Tag Archives: C. difficile biologic and development

Synthetic Biologics Announced Positive Topline Results From the First Phase 2a Study Of SYN-004 For C. difficile Infection Prevention

syntheticbiologics
Synthetic Biologics Announces Positive Topline Results from First Phase 2a Clinical Trial of SYN-004, the Company’s Candidate for the Prevention of C. difficile Infection

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen specific diseases, announced positive topline results from the first Phase 2a study of SYN-004, the Company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). Topline results from the ten ileostomized participants who completed the Phase 2a open-label study demonstrated that SYN-004 successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream.

Evaluation of the chyme from the ileostomized participants indicates that both dosage strengths of SYN-004 (75 mg and 150 mg) degrade residual IV ceftriaxone present in the chyme, supporting the mechanism of action of SYN-004. In addition, both dosage strengths of SYN-004 appear to be well tolerated by the participants in the study. Overall, the topline data support the hypothesis that SYN-004 has the capacity to degrade residual IV ceftriaxone in the GI tract, thereby preserving the balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms, without affecting the antibiotic level in the bloodstream intended for treatment of a primary infection.

“The completion of the first Phase 2a clinical trial for SYN-004 is an important achievement for Synthetic Biologics. These positive topline results demonstrate the potential for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea,” stated Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “The second Phase 2a clinical trial for SYN-004 is currently ongoing to evaluate the GI antibiotic-degrading effects and the safety of SYN-004 in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with functioning ileostomies. We anticipate reporting topline results from the second Phase 2a of SYN-004 during the first half of 2016.”

Mr. Riley concluded, “We are pleased to report additional progress from our SYN-004 program. We have begun dosing patients in the SYN-004 Phase 2b proof-of-concept clinical trial that is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection and C. difficile associated diarrhea, as well as antibiotic-associated diarrhea in up to 370 patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.”

 

First SYN-004 Phase 2a Clinical Trial Design

The Phase 2a randomized, multi-center, open-label study evaluated the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of 10 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consisted of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of IV ceftriaxone with one of two dosage strengths of oral SYN-004. Chyme samples were collected from the participants to measure the capability of SYN-004 to degrade the residual antibiotic in the GI tract. Participants were enrolled at two trial sites located in Canada.

 

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

http://money.cnn.com/news/newsfeeds/articles/prnewswire/CL69745.htm

 

— SYN-004 Degraded IV Ceftriaxone in Gastrointestinal Tract without Affecting
Antibiotic Levels in the Bloodstream —
— First Patients Dosed in Phase 2b Proof-of-Concept Clinical Trial for SYN-004 —
— SYN to Host Microbiome Clinical Program Seminar in NYC on Thursday, December 10, 2015

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 gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea, the timing of the reporting of topline results from the second Phase 2a of SYN-004, the potential market for SYN-004, and the intended therapeutics results of SYN-004 and SYN-010. 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, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products 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  Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

ii Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

C Diff Foundation Welcomes Dr. David Cook, Ph.D.

Welcome cloud

We are pleased to welcome

Dr. David Cook,Ph.D.

joining the C Diff Foundation’s Research and Development Committee and Research Community.

David Cook is a scientist and entrepreneur who has held senior operating and management positions in the biotechnology industry over his 20-year career. Before joining Seres Health, he was the chief operating officer for the International AIDS Vaccine Initiative (IAVI), a global R&D organization whose mission is to develop a safe, globally accessible vaccine for HIV. Prior to IAVI, David was the founding CEO at Anza Therapeutics, a biotechnology start-up developing a novel microbial vaccine platform to induce cellular immune responses to fight or prevent diseases such as cancer, hepatitis C, malaria and tuberculosis. Before launching Anza, David held positions of increasing responsibility at the biotechnology corporations Cerus and Eligix, with oversight over R&D, program management, manufacturing, and clinical and regulatory affairs. He has led teams to develop and commercialize several biotech products and has been directly responsible for obtaining marketing authorization from the European Union for four novel medical products. He is also a co-inventor on over twenty-five patents. He received his undergraduate degree from Harvard College and his Ph.D. in chemistry from the University of California, Berkeley.

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

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.