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Rebiotix and the C Diff Foundation Applaud the State of Minnesota as it Declares November C. difficile Infection Awareness Month

 Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, and the C Diff Foundation have joined today to voice support for the State of Minnesota in declaring November “C. difficile Infection Awareness Month.

Rebiotix and the C Diff Foundation believe this important action by Governor Mark Dayton and his administration adds significant weight to the ongoing effort to prevent and treat Clostridium difficile infection (C. diff.), which is a national health concern resulting in more than 500,000 infections and 29,000 deaths annually.

C. diff infection is a debilitating and potentially life-threatening condition that is now recognized as the number one healthcare associated infection in the U.S.,” said Lee Jones, president and CEO of Rebiotix.  “Increasing the awareness of this disease is important.  We applaud both the C Diff Foundation and the State of Minnesota in its effort to build awareness of this significant health concern and welcome the opportunity to be at the forefront of developing a potentially new treatment for patients to address the most challenging of C. diff infections.”

Rebiotix’s first product, RBX2660,  is intended to prevent recurrent C. diff infections. RBX2660 is currently the subject of a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate its efficacy and safety for the prevention of recurrent C. diff infection and is Rebiotix’s most clinically advanced drug product developed from the company’s Microbiota Restoration Therapy™ (MRT) platform.   Rebiotix is also advancing RBX7455, a lyophilized, non-frozen, oral capsule formulation of its MRT technology in an investigator sponsored Phase 1 study for the prevention of recurrent C. diff infection.

“The ability to prevent and potentially eradicate recurrent C. diff infection requires leadership from across the landscape of healthcare, from government institutions to advocacy to academia to emerging biotechnology companies,” said Nancy Caralla, founder of the C Diff Foundation.  “We commend the State of Minnesota and Rebiotix as each seeks to play an important role in reducing the rate and impact of C. diff infection.”

About Clostridium difficile Infection
Clostridium difficile (C. diff.) infection is a serious and potentially fatal gastrointestinal disease, characterized by severe diarrhea, fever, and loss of appetite. It is a leading healthcare-associated infection (HAI), and in the U.S. alone, there are about 500,000 people infected and over 29,000 deaths annually from the disease. Currently, 20-30% of patients with C. diff. go on to experience more than one episode of the disease, which is known as recurrent C. diff. infection. Recurrent C. diff. infection is especially challenging to treat as, to date, there are no approved microbial-based drugs to treat patients with two or more recurrences.

About the C Diff Foundation
The C Diff Foundation, a 501(c) (3)  non-profit organization, established in 2012, and comprised of 100% volunteering professionals dedicated at supporting public health through education and advocating for C. difficile infection (CDI) prevention, treatments, environmental safety, and support worldwide.  The Foundation’s founder is a Nurse and after suffering through C. difficile infections herself and witnessing the loss of her Father, whose life was claimed by C. difficile involvement, the C Diff Foundation came to fruition.  The C Diff Foundation Members, with  their Volunteer Patient Advocates, successfully “Raise C. diff. Awareness”  nationwide and in fifty-six  (56) countries and host a U.S. Nationwide information Hot-Line (1-844-FOR-CDIF) to support health care providers, patients, and families manage through the difficulties of a C. diff. infection among many other programs.

About Rebiotix Inc.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection.  RBX2660 has been granted Fast Track status and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff. infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff. infection.  In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy (MRT) platform.  MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

Minnesota Has Declared November “C. difficile Infection Awareness Month

 

 

 

 

http://www.clipsyndicate.com/video/play/7172019

According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

The state of Minnesota has declared November C. difficile Infection Awareness Month.” According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

Doctors at Mayo Clinic want people to know that they can get the infection even outside of hospitals. They also say once you get it, it’s easier to get it each time.

Dr. Sahil Khanna said ways to prevent C. diff is to wash hands and avoid unnecessary antibiotics.

He said Mayo Clinic is also studying whether or not there could be a vaccination for C. Diff.

“So there’s a large multi-center study that’s going on right now in people who may be at risk for C. Diff infection,” Khanna said. “So if you’ve been to the hospital, if you’ve received antibiotics, those patients can be enrolled in a vaccine study to see if this vaccine would prevent C. Diff from happening.”

Mayo Clinic is also working with Minnesota-based company Rebiotix on another form of treatment for the infection where people can simply ingest a tablet.

“Newer studies are being derived where you can actually take material from donor stool, process donor stool in a lab, and derive all the good bacteria that you need from the donor stool and put them in capsule form,” Khanna said.

Khanna said this capsule-based treatment has more advantages than a colonoscopy-based treatment that is currently being used to treat C. Diff.

 

Rebiotix Features Three Posters Highlighting RBX2660 Clinical and Microbiome Data at ID Week™ 2017 in San Diego, October 4th – 8th

Positive Topline Data from Open-Label Phase 2 Trial of RBX2660 in Recurrent Clostridium
difficile to be Presented for First Time

 

 

 

Rebiotix Inc., a clinical-stage microbiome company focused
on harnessing the power of the human microbiome to treat challenging diseases, today announced that three posters highlighting RBX2660 clinical and microbiome data will be featured at ID Week™ 2017 in San Diego, Oct. 4th to the 8th.

The posters describe clinical findings that highlight the key changes to
the human microbiome profiles of patients who received RBX2660, Rebotix’s Phase 3 drug candidate.

For the first time, researchers will discuss findings from the open-label Phase 2 trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff.) infection. Data indicated that RBX2660 was well tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001, N=242). These results demonstrate a 55% reduction in recurrence for those patients treated with RBX2660 compared to the historical controls reflecting standard-of-care antibiotics today.

RBX2660 is currently being evaluated in a multinational Phase 3 clinical trial for the prevention of recurrent C. diff.  Researchers will also be presenting two posters on the microbiome analyses of the Phase 2B  randomized, placebo-controlled, double-blind clinical trial of RBX2660. The analyses, utilizing leading  edge genomic sequencing technology to measure the patient’s microbiome, provide measurable  evidence of RBX2660’s rehabilitative effect on human microbiome profiles of patients who were successfully treated with Rebiotix’s microbiota drug technology.

“The clinical potential of RBX2660 has been highlighted in multiple trials, including our recently
completed open-label Phase 2 study, and the data being presented at ID Week enables us to more fully understand RBX2660’s ability to rehabilitate a dysbiotic intestinal microbiome,” commented Lee Jones, president and CEO of Rebiotix. “These findings are important in that not only can we observe the clinical 2 effect of RB X2660, such as in the open-label Phase 2 study, but by analyzing the microbiota of RBX2660-treated patients, we can see how the microbiome changes in response to RBX2660 treatment and how those changes correlate to treatment success and to the microbiomes of healthy individuals.”

The first poster (#1863; to be presented Friday, Oct. 6th), titled RBX2660 is Safe, Superior to Antibiotic- Treated Controls for Preventing Recurrent Clostridium difficile, and May Rehabilitate Patient Microbiomes:  Open Label Trial Results, reported data from an open-label Phase 2 study of RBX2660 that included 242 subjects. Data from the study indicated that RBX2660’s efficacy in preventing recurrent Clostridium difficile infection (rCDI) was higher (78.8%) than CDI-free rates in the Historical Control Group (51.8%, p<0.0001). The reduction in recurrence of C. diff between these two arms is approximately 55%. Moreover, the safety profile of RBX2660 was consistent with results from previous clinical trials, and microbiota analysis suggested that RBX2660 may rehabilitate patient microbiota as RBX2660-treated subjects’ microbiomes were significantly altered compared to baseline and more closely resembled the RBX2660 microbiome profile than at baseline (p<0.05 by Dirichlet multinomial Wald-type pairwise hypothesis test).

The second poster (#1267; to be presented Saturday, Oct, 7th), titled Successful Response to
Microbiota-Based Drug RBX2660 in Patients with Recurrent Clostridium Difficile Infection is Associated with More Pronounced Alterations in Microbiome Profile, involved an analysis of 58 patients whose stool samples were collected in the randomized Phase 2B clinical trial to determine the effect of RBX2660 on rCDI patient microbiomes. 16s RNA sequencing analyses of patients’ microbiomes indicated that RBX2660 treatment shifted the relative microbiome densities, with taxa-specific increase in Bacteroidia, Clostridia, and decrease in Gamma-proteobacteria abundance. Importantly, a larger shift from baseline microbiome was seen in responders to RBX2600 compared to non-responders, and RBX2660 treatment appears to increase microbiome diversity.

 

The third poster (#1870; to be presented Saturday, Oct. 7th), titled Microbiome Profile is Distinct in Patients with Successful Response to Microbiota-Based Drug RBX2660 Relative to Placebo Responders involved a sub-analysis of 57 patients who participated in the randomized Phase 2B clinical trial of RBX2660. 16s rRNA sequencing analysis was used to compare the microbiome changes from baseline of patients classified as responders to RBX2660 vs placebo. Investigators determined that RBX2660 treatment for rCDI is associated with greater changes in patient microbiomes than placebo treatment. Notably, at 7, 30 and 60 days, microbiomes from RBX2660-treated patients had high Kullback-Leibler divergence from baseline and significantly different means from baseline (p<0.001). Further, active responders trended toward higher Bacteroides and lower Gamma-proteobacteria and Bacilli after treatment, both of which are characteristic of a healthier microbiome. According to the 3 researchers, these changes are consistent with the hypothesis that RBX2660 can restore a healthier microbiome in rCDI patients.

Rebiotix, Inc. funded all three studies.

For More Information About Rebiotix Please

Click On the Following Link:

http://www.rebiotix.com

First Patient Is Enrolled In Rebiotix Phase 3 Clinical Trial of RBX2660 For the Prevention of Recurrent C. difficile Infection

REBIOTIX

 

Phase 3 Clinical Trial of RBX2660 for the Prevention of

Recurrent Clostridium difficile Infection

Phase 3 Initiation Advances Development of Lead Microbiome-based Drug, RBX2660, Following Completion of Three Separate Phase 2 Trials

Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that it has enrolled the first patient in a Phase 3 clinical trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection.

RBX2660 is Rebiotix’s most clinically advanced drug product developed from the company’s Microbiota Restoration Therapy™ (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to deliver a broad consortium of spore and non-spore forming microbes into a patient’s intestinal tract to restore a dysbiotic gut to a healthier state.

The randomized, double-blind, placebo-controlled Phase 3 clinical trial will evaluate the efficacy and safety of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection. The primary endpoint of the trial compares the proportion of subjects with treatment success following a blinded treatment with RBX2660 compared to the blinded placebo arm. Treatment success is defined as preventing recurrent C. diff infection for eight weeks. The multicenter Phase 3 clinical trial of RBX2660 will be conducted in the United States and Canada and is designed to support a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).

“Patients with debilitating, recurrent C. diff need solutions. We plan to continue our strong momentum generated by our Phase 2 results in this Phase 3 trial as we seek to advance RBX2660 toward registration and potential approval so patients have an option for this unmet medical need,” said Ms. Lee Jones, President and CEO of Rebiotix. “Initiating the Phase 3 clinical study of RBX2660 is a significant milestone for Rebiotix and showcases the potential of our Microbiota Restoration Therapy™ (MRT) platform to enable the development of microbiome-directed drug products.”

“It’s exciting to see RBX2660 begin a Phase 3 trial for recurrent C. diff infection,” said Dale Gerding, MD, MACP, FIDSA, Professor of Medicine at Loyola University Chicago and Chief Medical Officer of Rebiotix. “This disease is especially challenging to treat and having this microbial therapy available to physicians could dramatically change how we manage the vexing problem of recurrences of this leading healthcare-associated infection.”

RBX2660 is the first drug product in clinical study from the Microbiota Restoration Therapy (MRT) platform The initiation of the Phase 3 clinical trial follows a Phase 2 program that evaluated the safety and efficacy of RBX2660 for the prevention of recurrent C. diff infection. The Phase 2 program consisted of three separate Phase 2 studies, including a randomized, double-blind, placebo controlled Phase 2b trial. The drug has been tested in approximately 300 patients with many followed to 24 months post treatment. Rebiotix is also advancing RBX7455, a lyophilized, room-temperature stable, oral capsule formulation of its MRT technology in an investigator sponsored Phase 1 study

For more information on Rebiotix and its pipeline of human microbiome directed therapies, visit

www.rebiotix.com.

Rebiotix a Clinical Stage Microbiome Company Shared RBX2660 and RBX7455 Clinical Study Data At ASM Microbe 2017


Rebiotix Inc a clinical stage microbiome company focused on
harnessing the power of the human microbiome to treat challenging diseases, announced that it presented three posters during the American Society for Microbiology’s ASM Microbe 2017, held

June 1-5, 2017 in New Orleans.

Two posters include microbiome data analyses from a randomized placebocontrolled
Phase 2b clinical study featuring RBX2660,

Rebiotix’s Phase 3-ready broad-spectrum
microbiota suspension designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.

A third poster was also presented showing a meta analysis
of placebo response rates  among recurrent Clostridium difficile clinical trials, which provides a field benchmark for future clinical studies.

“The two microbiome analysis posters presented during ASM Microbe 2017 were very important in illustrating the ability of RBX2660 to potentially rehabilitate the microbiome of patients with C. difficile infections.  Two separate data analyses from the PUNCH CD2 Phase 2b clinical trial of RBX2660 demonstrated that patients successfully treated with RBX2660 exhibited microbiomes that more closely  align with healthy subjects, and that one dose of RBX2660 is sufficient to induce microbiome changes  associated with successful outcomes,” stated Lee Jones, president and CEO of Rebiotix.

The poster titled “Changing the Microbiome: Patients with a Successful Outcome Following Microbiota- Based RBX2660 Treatment Trend Toward Human Microbiome Project Healthy Subjects’ Profile,”   detailed the results of the PUNCH CD2 Phase 2b trial of the microbiome-based drug, RBX2660.

In this trial, a single dose of RBX2660 demonstrated a significantly better treatment response rate of preventing recurrent Clostridium difficile infections than placebo (67% vs 46%, respectively; p = 0.048).

In a further analysis, investigators determined that patient microbiomes became more diverse and more closely aligned to a healthy microbiome as defined by the Human Microbiome Project (HMP) after treatment with RBX2660, with the largest shift occurring seven days after treatment. 2  The second poster, titled “Resetting the Microbial Landscape: Donor Microbiome Engraftment in  Patients Treated with RBX2660 for Multi-Recurrent Clostridium difficile Infection,” further elaborated on  the shift of the patient microbiome profile towards the profile of RBX2660. In this poster, 16S rRNA sequencing was performed on stool samples collected from 42 subjects in the RBX2660 treatment arm and 19 RBX2660 drug lots. The RBX2660 microbial profiles had similar taxonomic distributions, with a
group mean that was highly divergent and significantly different from patient baseline microbiome  profiles. After RBX2660 treatment, the patients’ microbiomes progressively shifted to more closely  resemble RBX2660, with the largest shift occurring 7 days after treatment. Further work is planned to  define specific taxa and strains that directly engraft from RBX2660 to the patient. Importantly, this study  also confirmed that one dose of RBX2660 is sufficient to support the microbiome change associated
with successful outcome.

About Rebiotix Inc.
Rebiotix Inc. is a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically  advanced microbiome company in the industry, with its lead drug candidate, RBX2660, expected to  enter Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection.

RBX2660 has been granted Fast Track status and Breakthrough Therapy designation from the FDA for  its potential to prevent recurrent C. diff. infection.

Rebiotix’s clinical pipeline also features RBX7455, a room temperature stable oral capsule formulation, which is currently the subject of an investigator sponsored  Phase 1 trial for the prevention of recurrent C. diff. infection. In addition, Rebiotix is targeting  several other disease indications with drug products built on its pioneering Microbiota Restoration Therapy (MRT) platform.

MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s  intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

Rebiotix Reports Topline Results From a Controlled Open-label Phase 2 Trial of RBX2660 (PUNCH™ Open Label) For the Prevention of Recurrent Clostridium difficile (C. diff.) Infection (rCDI)

In The News

April 2017

 

 

Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced topline results from a controlled open-label Phase 2 trial of RBX2660 (PUNCH™ Open Label) for the prevention of recurrent Clostridium difficile (C. diff.) infection.

Data indicated that RBX2660 was well-tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001). RBX2660 is a broad-spectrum microbiota suspension that is designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.

Lee Jones, president and CEO of Rebiotix, stated, “The 78.8% treatment success achieved in this open label Phase 2 trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff. recurrence. These results, coupled with the safety and efficacy data observed in our prior Phase 2b and Phase 2 clinical trials, position Rebiotix to advance RBX2660 into Phase 3 clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry.”

PUNCH™ Open Label was designed as a prospective, multicenter, open-label, controlled Phase 2 study to assess the efficacy and safety of RBX2660 for the prevention of recurrent C. diff.

The primary efficacy endpoint involved a comparison of patients treated with RBX2660 to a closely matched set of antibiotic only treated historical controls through 56 days. There were 31 active treatment sites and four control sites in the US and Canada. 132 RBX2660 and 110 historical control subjects were included in this topline analysis.

Actively treated patients, after determining eligibility, were administered two doses of RBX2660; the first at day one and the second at day seven. Patients were then monitored for eight weeks to determine whether there was a recurrence of C. diff.

Top line results from the trial, which examined responses from 132 patients versus a historical control of 110 patients, indicated a treatment success rate of 78.8% as compared to a historical control of 51.8% (p<0.0001). Overall, RBX2660 was generally well-tolerated with the most commonly reported adverse events being gastrointestinal, including diarrhea, abdominal pain, flatulence, constipation and distension.


About Rebiotix Inc.

Rebiotix Inc. is a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its lead drug candidate, RBX2660, expected to enter Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff.) infection. Previously, RBX2660 was the subject of three Phase 2 trials in recurrent C. diff, including a Phase 2b randomized, double-blind, placebo-controlled trial (PUNCH™ CD2), with data indicating the drug was well-tolerated and demonstrated statistically significant treatment efficacy. RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to prevent recurrent C. diff. infection.

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

For More Information About C. difficile Clinical Trials In Progress : 

https://cdifffoundation.org/clinical-trials-2/

 

For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

 

Source:  Rebiotix 4/17

Rebiotix Treats First Patient In Phase 1 Study of RBX7455 Oral Capsule – A Formulation of Rebiotix’s Microbiota Restoration Therapy (MRT)

rebiotixlogo

Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017

 

Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.

RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.

This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.

  • RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.

“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”

The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH™ CD2).

“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”

RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”

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