Ritter Pharmaceuticals Reports Microbiome Data from Phase 2b Study of RP-G28 Promotes Beneficial Adaptation of the Gut Microbiome
- Category: Small Molecules
- Published on Monday, 12 March 2018 15:51
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LOS ANGELES, CA, USA I March 12, 2018 I Ritter Pharmaceuticals, Inc. (NASDAQ:RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of novel therapeutics that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of the first FDA-approved treatment for lactose intolerance, announced today that its lead drug, RP-G28, promoted beneficial adaptation of the gut microbiome in its Phase 2b study of 377 lactose intolerance patients.
In a report prepared by Andrea Azcarate-Peril, Ph.D., Associate Professor of Medicine at University of North Carolina at Chapel Hill, RP-G28 modified the relative abundance of 28 bacterial species. Specifically, a dramatic increase in species of Bifidobacterium was observed, including some known to metabolize lactose. The understood mechanism of action of RP-G28 for mitigating lactose intolerance symptoms is by increasing lactose-metabolizing bacteria in the colon that compensate for the deficit of endogenous lactase activity. These beneficial bacteria remove the undigested lactose found in dairy products from the gut thus reducing the gas production and water retention that produce lactose intolerance symptoms.
“These findings are consistent with the Phase 2a clinical data of RP-G28 for the treatment of lactose intolerance,” commented Dr. Azcarate-Peril. “During the Phase 2a study, we observed an increase in bifidobacteria, which were confirmed in this larger Phase 2b study. This is significant since Bifidobacterium have proven health benefits for both the gastrointestinal tract and the immune system.”
Key findings of the study’s microbiome data include the following:
- Treatment with RP-G28 resulted in a beneficial adaptation of the microbiome and a significant impact on the abundance of 28 bacterial species.
- High-throughput quantitative polymerase chain reaction (qPCR) data showed a clear and significant increase in the relative abundance of the phylum Actinobacteria, family Bifidobacteriaceae, genus Bifidobacterium and family Lactobacillaceae after 30 days of treatment, in both groups of RP-G28 treated patients, but not in the placebo group. Specifically, abundances of B. angulatum, B. gallicum, B. longum, B. bifidum, B. breve, and B. catenulatum were increased by treatment with RP-G28.
- Actinobacteria of the family Bifidobacteriaceae increased in a higher proportion of treated patients. Bifidobacteria increased in 77.7% (77/99) of individuals in the treatment group compared to 52.1% (49/94) in the placebo group (p=<.001), correlating with a similar trend reflected in the Phase 2a data.
- Pediococcus, species of the Lactobacillales order, Enterococcaceae, and Delftia were increased in clinical responders after days 30 of treatment in both low and high dose patient groups.
“These results confirm an effective mode of action for RP-G28 and further support the therapeutics’ potential for use in other indications,” added Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, Inc. “As we move forward with our Phase 3 clinical trial of RP-G28 for the treatment of lactose intolerance in Q2 2018, we will consider how these findings can make a positive impact for patients beyond lactose intolerance in other indications.”
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company’s lead product, RP‐G28, has the potential to become the first FDA‐approved treatment for lactose intolerance, a condition that affects millions worldwide. RP-G28 has been studied in Phase 2 trials and is now in Phase 3 clinical development. The Company is further exploring the functionality and discovering the therapeutic potential gut microbiome changes may have on treating/preventing a variety of conditions including: gastrointestinal diseases, immuno‐oncology, metabolic, and liver disease.
SOURCE: Ritter Pharmaceuticals