Category Archives: Biologic Research & Development

In The News - Synthetic Biologics’ SYN-004 Microbiome-Protecting Preclinical Data Highlighted in Late-Breaking Poster at DDW 2015

syntheticbiologics

Synthetic Biologics, Inc. a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, presented preclinical results in a late-breaking poster at Digestive Disease Week® (DDW) 2015 in Washington, DC today. The research supports the development of SYN-004, the Company’s candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD). Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.

The “SYN-004, a Clinical Stage Oral Beta-Lactamase Therapy, Protects the Intestinal Microflora from Antibiotic-Mediated Damage in Humanized Pigs” poster summarized preclinical efficacy data that support the ability of SYN-004 to degrade certain beta-lactam antibiotics in the GI tract, with the following conclusions:

  • In fistulated dogs, oral delivery of SYN-004 resulted in efficient degradation of ceftriaxone in the GI tract, and
  • In humanized pigs, SYN-004 protected the intestinal microflora from ceftriaxone and maintained the natural balance of the microbiome.

“The data suggest that SYN-004 has the potential to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, including C. difficile infection, in patients receiving beta-lactam antibiotics,” stated Michael Kaleko, M.D., Ph.D., Senior Vice President, Research & Development of Synthetic Biologics.

“These findings support our ongoing Phase 2a clinical trial that is evaluating the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream,” noted Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

“We are on schedule to report topline data from the Phase 2a clinical trial of SYN-004 this quarter, with a Phase 2b clinical trial anticipated to initiate during the second half of this year.”

The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an “urgent public health threat,” and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of certain IV antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year. Approximately 118 million doses of IV beta-lactam antibiotics[iii] that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a monoclonal antibody combination for the treatment of Pertussis in collaboration with Intrexon Corporation (NYSE: XON), and a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential for SYN-004 to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, anticipated timing of the topline data from the Phase 2a and the initiation of the Phase 2b clinical trial and the size of the market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, the ability of SYN-004 to perform as expected, the results of the clinical trials and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

[i] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[ii] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

[iii] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

C. diff. Radio talk show “C.diff. Spores and More” debuts on Tuesday, March 3rd

What’s new in the C Diff Foundation?

Let us introduce you to the first internet radio talk show dedicated to C. diff. and more……

“C. diff. Spores and More”

#Cdiffradio

We invite you to join us in listening to this exciting, new internet talk show when it debuts Tuesday, March 3rd, 2015 at the following times:

ET 2 – 3 p.m., CT 1 – 2 p.m., MT 12 – 1 p.m., PT 11 – 12 p.m.

We are so excited to share the debut of “C. diff. Spores and More” with you – not only because the C Diff Foundation, our Founding Executive Director – Nancy C. Caralla, and Chairperson of Research and Development – Dr. Chandrabali Ghose, are introducing the first episode, but also because, as advocates of C. diff., we are very excited about what this cutting-edge new weekly radio show means for our Foundation’s community worldwide.

Fact: Deaths and illnesses are much higher than reports have shown. In March, 2012 the CDC said in a report that the C difficile infection kills 14,000 people a year. But that estimate is based on death certificates, which often don’t list the infection when patients die from complications, such as kidney failure. Hospital billing data collected by the federal Agency for Healthcare Research and Quality shows that more than 9% of C. diff-related hospitalizations end in death — nearly five times the rate for other hospital stays. That adds up to more than 30,000 fatalities among the 347,000 C. diff hospitalizations in 2010. Thousands more patients are treated in nursing homes, clinics and doctors’ offices.

“We’re talking in the range of close to 500,000 total cases a year,” says Cliff McDonald, a C. diff expert and senior science adviser in the CDC’s Division of Healthcare Quality Promotion. And annual fatalities “may well be … as high as * 30,000.”

* AHRQ News and Numbers provides statistical highlights on the use and cost of health services and health insurance in the United States.

“This does not include the number of C. diff. infections taking place and being treated in other countries.” “The CDF supports hundreds of communities by sharing the CDF mission and raising C. diff. awareness to healthcare professionals, individuals, patients, families, and communities working towards a shared goal ~ witnessing a reduction of newly diagnosed C. diff. cases by 2020 .” ” The CDF Volunteers are greatly appreciated as they create positive changes sharing their time so generously worldwide aiding in the success of our mission and raising C. diff. awareness.”

“C. diff. Spores and More” will spotlight world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more. Through their interviews, the CDF mission will connect, educate, and empower many in over 180 countries.

Please join us in listening to the first of many episodes of “C. diff. Spores and More” debuting on Tuesday, March 3rd .

View the programs and radio information:

health.voiceamerica.com

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

President Obama Will Announce Launch of $215M Precision Medicine Initiative

laboratorytests

President Obama today will announce the launch of a $215 million precision medicine initiative to leverage advances in genomics, informatics, and health information technology to accelerate biomedical discoveries in the hopes of yielding more personalized medical treatments for patients in the US.

The public-private initiative, which will be included in the President’s 2016 budget proposal to be released next week, will provide new funding to the National Institutes of Health, the National Cancer Institute, the US Food and Drug Administration, and the Office of the National Coordinator for Health Information.

That funding will help those agencies to, among other things, develop a voluntary national research cohort of more than 1 million people, obtain sequencing data for as many of those individuals as possible, identify genomic drivers of cancer, improve how next-generation sequencing-based tests are evaluated and marketed, and develop methods for managing and analyzing large patient data sets while protecting individual privacy.

“Precision medicine is about moving beyond this one-size-fits-all kind of approach to medicine and instead approaching disease prevention and treatment by taking into account individual differences in people’s genes, their microbiomes, their environments, and their lifestyles,” Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy, said yesterday in a press briefing previewing today’s announcement. “The idea is to give clinicians tools to better understand the mechanisms underlying a patient’s condition, and to better predict which treatments will be most effective and safe.”

The largest part of the initiative will provide $130 million to the NIH to help develop a national research cohort of a million or more volunteers whose data — including medical records, genetic and metabolomic profiles, microbiomes, and environmental and lifestyle information — will contribute to a further understanding of disease and help establish a new way of doing research through engaged participants and open, responsible data sharing, the White House said.

In addition, the NCI will be budgeted for $70 million to scale up efforts to understand the genetic basis of cancer by expanding genetically based clinical trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” that will generate and share new knowledge.

Meantime, $10 million will be earmarked for the FDA to help it acquire additional tools and expertise to develop high-quality, curated databases that will be used in its efforts to evaluate next-generation sequencing technologies and ensure their accuracy, reliability, and safety for patients.

And, finally, the initiative calls for a $5 million investment in the ONC to support the development of interoperability standards and requirements that address patient privacy and enable the secure exchange of data across systems.

“This concept of precision medicine – that is, prevention and treatment strategies that take individual differences into account – is not entirely new,” NIH Director Francis Collins said during the briefing. “But for much of medicine, this kind of personalizing just has not been possible. We just didn’t know enough. That’s all changing now, and at an unprecedented pace, which makes now the right time to launch this initiative.”

Collins pointed to advances over the past several years in basic research, data science, mobile connectivity, use of electronic medical records, and “perhaps most dramatic of all in terms of the scale, the decline in the cost of DNA sequencing. It cost us $400 million for that first genome, and now a genome can be sequenced for a cost approximating $1,000. That’s more than 100,000-fold drop in 15 years.”

Regarding the NIH’s plan to create a longitudinal cohort of more than 1 million patients, Collins noted that the agency and its partners will not need to start from scratch, but will instead tap into already-established cohorts, both public and private.

“We are aware that there is something like 200 cohorts that have already been put in place that have at least 10,000 participants,” Collins said. “They’re in different sorts of shape as far as the kind of information that’s already been collected. But there is a wealth of potential there.”

Collins noted that a large part of this cohort effort will be trying to piece together many of these existing cohorts, and he said that this could be aided by existing projects such as the Electronic Medical Records and Genomics (eMERGE) program, which aims to combine electronic medical records technologies with DNA biorepositories for use in large-scale, high-throughput genomics research projects.

In terms of the types of existing cohorts that could be tapped into, Collins mentioned the attractiveness of the cohorts generated so far under Kaiser Permanente’s Research Program on Genes, Environment, and Health, which includes more than 430,000 adult members of Kaiser’s system in Northern California and has generated a 100,000-individual cohort in partnership with the University of California, San Francisco. However, Collins stressed that the NIH will be encouraging new participants to volunteer to help build the national cohort.

Another large part of the cohort effort will be attempting to obtain sequencing data for as many of the participants as possible. Although the cost of sequencing has dropped dramatically in recent years, this component of the initiative remains a major hurdle.

“We would love to have whole-genome sequence [data] on all the participants in the cohort, but the expense has to be considered, and where are we going to find those funds?” Collins said. Although it now costs about $1,000 to sequence a whole genome, “that curve is coming down, and that is actually quite reassuring,” Collins added. “It will take us, of course, a matter of some time to assemble this cohort. Our expectation would be that, as it’s being assembled, the cost [of sequencing] would be coming down, and so ultimately the goal would be to have a full-genome sequence on as many of the cohort as are comfortable.”

Another important aspect of the national cohort project will be its interactive nature. “The precision medicine initiative is not just about scale,” Collins said. “It’s also intended to be a new model of research, one in which people who participate are true partners – not subjects, not even patients – partners.”

To that end, the ONC is charged with developing new and better ways to ensure secure data exchange with patients’ consent, and the initiative overall will be committed to protecting patients’ privacy by launching a “multi-stakeholder process” that will solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify legal and technical issues.

Summarizing, Collins noted that although the cohort initiative will likely yield its greatest benefits many years into the future, “there should be some successes in the relatively near future, as well, especially in the areas of cancer, and the field called pharmacogenomics – how to provide the right drug at the right dose to the right patient at the right time. This initiative will provide a wonderful platform for finding out how to apply that strategy to more and more people.”

On the regulatory side, FDA Commissioner Margaret Hamburg noted during the briefing that the agency’s funding would primarily be used to improve the way it oversees the marketing of new types of precision medicine technologies, particularly NGS.

“Our current market review approaches for evaluating a test’s analytical and clinical performance are designed around a more traditional one test-one disease paradigm,” Hamburg said. “In contrast, next-generation sequencing produces a massive amount of data, potentially bearing on a huge range of diseases, conditions, and risk factors that will be better handled using a new approach.”……………………………………….

…………. the FDA is currently in the process of considering what that approach should be, referring to the fact that the agency has scheduled a public meeting on Feb. 20 to discuss the challenges of regulating NGS technologies. Ahead of the meeting, last year the agency issued a white paper to lay out its current thinking and provide the basis for future discussion.

President Obama plans to fully announce the precision medicine initiative at an 11:00 AM event at the White House today.

 

To read the article in its entirety please click on the following link:

https://www.genomeweb.com/policy-legislation/president-obama-launch-215m-precision-medicine-initiative?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Daily%20News:%20President%20Obama%20to%20Launch%20$215M%20%27Precision%20Medicine%27%20Initiative%20-%2001/30/2015%2011:10:00%20AM

C. difficile Prevention Clinical Trials; Synthetic Biologics Announces Positive Results from Phase 1a of SYN-004

In the news:

Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection

Synthetic Biologics, Inc. a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced positive top-line safety and tolerability results from a Phase 1a clinical trial of SYN-004, the Company’s investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

Since December 2nd, 2014 the randomized double-blind, placebo-controlled Phase 1a clinical trial conducted at Clinical Pharmacology of Miami, has enrolled 24 healthy volunteers in three cohorts of eight patients each. A total of 18 volunteers have been administered one dose of SYN-004 at increasing dose levels by cohort, and six volunteers received placebo. No clinically significant or relevant adverse events have been reported to date.

“Completing the first safety review and reporting positive top-line results in the Phase 1a clinical trial of SYN-004 is an important event for Synthetic Biologics, bringing us closer to the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat. Achieving this milestone moves us closer to validating our ground-breaking approach to preventing C. difficile infection in a way that protects the gut microbiome, which also holds the hope of treating a variety of GI, metabolic and CNS disorders,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

Mr. Riley added, “Based on the results observed in the first three cohorts, and per our clinical plan, we intend to proceed with our planned multiple-ascending dose placebo-controlled Phase 1b study of SYN-004, in which healthy volunteers will receive increasing doses of SYN-004 over several days. We expect enrollment into our Phase 1b SYN-004 clinical trial to begin before year-end, with top-line data available during the first quarter of 2015. We also expect to initiate enrollment in a Phase 2 SYN-004 clinical trial ahead of schedule during the first quarter of 2015.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent C. difficile infection. Its mechanism of action is to bind with and neutralize certain common IV beta-lactam antibiotics in the gut.

During 2012, 14.4 million U.S. patients received approximately 117.6 million doses of IV antibiotics [i] that could be inactivated in the gastrointestinal (GI) tract by SYN-004.

SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infections[ii] and 30,000 C.difficile related deaths[iii] in the United States each year.

The U.S. Centers for Disease Control (CDC) has identified C. difficile as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal pain, cramping, nausea, colitis, and even death. In all, 24 million Americans receive IV antibiotics annually [iv].

References:

[i] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[ii] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[iii] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

[iv] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

SOURCE Synthetic Biologics, Inc.

For further information: Synthetic Biologics:

Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

To read this article in its entirety please click on the link below:

https://ca.finance.yahoo.com/news/synthetic-biologics-announces-positive-topline-115800549.html

C. difficile Infection Prevention; Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004

Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004
for the Prevention of C. difficile Infection
First-in-Class Clinical Program Targets Protection of Microbiome to Prevent Overgrowth of deadly C. difficile Infection Linked with Use of IV Antibiotics
Rockville, MD, December 2, 2014 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1a clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

The randomized, double-blind, placebo-controlled Phase 1a study, which is now underway at Clinical Pharmacology of Miami, is designed to evaluate the safety, tolerability and pharmacokinetics of five single ascending doses of oral SYN-004 in healthy volunteers.

In all, up to 40 healthy adult volunteers will be enrolled into five cohorts, with approximately six participants receiving SYN-004 and two receiving placebo in each cohort. Before the end of the year, top line Phase 1 data is expected to be reported and a Phase 1b study evaluating multiple-ascending doses of SYN-004 is planned to begin.

“The initiation of the clinical program for SYN-004 represents an important milestone for Synthetic Biologics and a key step towards the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We look forward to moving Synthetic Biologics’ innovative therapeutic approach to prevent C. difficile infection through
clinical development, and further validating the connection between protecting the gut microbiome and a variety of GI, metabolic and CNS disorders.”

Currently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection, which the U.S. Centers for Disease Control (CDC) has identified as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal
pain, cramping, nausea, colitis, and even death.

In all, 24 million Americans receive IV antibiotics annually.
SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV betalactam antibiotics in the gut.

For further information, please contact:
Synthetic Biologics: Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
ii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
iii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
iv U.S. Department of Health & Human Services. Agency for Healthcare

C. difficile Prevention; Synthetic Biologics Safe-to-Proceed Under IND to Initiate Clinical Trials of SYN-004

Phase 1a and 1b Trials to Use SYN-004 to Protect Microbiome; Intended to Prevent Overgrowth of Potentially Deadly C. difficile Bacteria

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that its Investigational New Drug (IND) application which was submitted to the U.S. Food and Drug Administration (FDA) in October will be proceeding into clinical trials for the development of the Company’s oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous (IV) beta-lactam antibiotic therapy. Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end.

“We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Taking immediate and aggressive action to develop a therapy that can prevent C. difficile before it starts is critical in addressing this pervasive and life-threatening infection, and IND activation for SYN-004 is a key step toward the development and eventual commercialization of therapy to protect the millions of at risk U.S. patients.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only prophylactic treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV beta-lactam antibiotics in the gut. SYN-004 is intended to block the unintended harmful effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infectionsii and 30,000 C. difficile-related deathsiii in the U.S. each year.

Synthetic Biologics has met each milestone for its C. difficile program leading up to the IND submission to the agency. Clinical drug manufacturing of SYN-004 under cGMP guidelines to support Synthetic Biologics’ planned Phase 1 and 2 clinical trials was completed on time to support the IND submission and clinical trial initiation. Most recently, the U.S. Patent and Trademark Office issued a Notice of Allowance for the first composition of matter patent application directly pertaining to SYN-004 in the U.S., which carries a patent term to at least 2031.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage biotechnology company developing pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome. The Company is developing an oral biologic to protect the gastrointestinal (GI) microflora from the effects of intravenous (IV) antibiotics for the prevention of C. difficile infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS) and a monoclonal antibody combination for the treatment of Pertussis being developed in collaboration with Intrexon Corporation (XON). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

For the complete Press Release article - click on the following link:

https://ca.finance.yahoo.com/news/synthetic-biologics-safe-proceed-under-115700305.html

Synthetic Biologics, Inc. Is Issued a Notice of Allowance for a Composition of Matter Patent Application covering SYN-004, Leading Product in its C. difficile Program

* In the news *

Synthetic Biologics, Inc., a biotechnology company developing novel pathogen-specific therapies for serious infections and diseases, announced that as of October 22, 2014 the U.S. Patent and Trademark Office has issued a Notice of Allowance for a composition of matter patent application that covers the lead product in its C. difficile program, SYN-004. This is Synthetic Biologics’ first allowed patent application directly pertaining to SYN-004 in the U.S. and adds to the Company’s extensive C. difficile patent estate.

Synthetic Biologics, Inc. Logo

SYN-004 is Synthetic Biologics’ novel oral enzyme drug candidate designed as the first and only prophylactic treatment intended to prevent the development of C. difficile infections, by binding with and neutralizing certain intravenous (IV) beta-lactam antibiotics in the gut.

SYN-004 is intended to block the effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of bacterial flora (the gut microbiome), potentially preventing the 1.1 million C. difficile infections in the U.S. each year. The U.S. patent to be issued has claims to compositions of matter and pharmaceutical compositions of beta-lactamases, including SYN-004, and carries a patent term to at least 2031. In addition to the newly allowed patent, the Company has numerous related granted and pending U.S. and international patent applications that are central to the Synthetic Biologics’ intellectual property estate.

“This new patent will strengthen the protection of Synthetic Biologics’ SYN-004 and reiterates our position as a key player in the prevention of microbiome-based diseases,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We continue to bolster the Company’s patent estate while making progress towards our goals to initiate Phase Ia and Ib C. difficile clinical trials this quarter.”

 

Resource: Synthetic Biologics news release.