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