Ritter Pharmaceuticals, a developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced its Phase 3 plans following its End-of-Phase 2 meeting with the U.S. FDA regarding the path forward for RP-G28 for the treatment of lactose intolerance (LI).
The Company has incorporated guidance from the FDA on key elements of its Phase 3 program and received clear guidance and expectations on necessary components, including clinical, non-clinical, and chemistry, manufacturing and controls (CMC) requirements needed to support a successful NDA submission.
William Sandborn, M.D., Chief, Division of Gastroenterology at University of California San Diego commented, “The FDA meeting was very collaborative and constructive in helping the Company fully understand the agency’s objectives and expectations of the Phase 3 program. Having guidance and agreement on key clinical items such as screening methods to ensure an appropriate patient population, validated measures to capture appropriate clinical outcomes and well-defined endpoints for assessment, I believe the Company is well-positioned to enter Phase 3 trials to meet the FDA’s guidance on the expected clinical aspects needed for a successful NDA filing.”
Meeting highlights include:
• The Phase 3 clinical program: Will consist of two confirmatory clinical trials of similar trial design and size as the Company’s Phase 2b/3 clinical trial and will include additional components to allow for claims for durability of effect. The trials may be run in parallel. The Company anticipates initiating the Phase 3 program during the first half of 2018.
• Protocol design: Will consist of multi-center, randomized, doubled-blind, placebo-controlled, parallel-group trials designed to determine the efficacy, safety and durability of RP G28 compared to a placebo in subjects with lactose intolerance. The protocol designs include screening to determine lactose intolerance, 30-day course of treatment, and 6-months of post-treatment observation.
• Primary endpoint: Will evaluate a patient’s composite LI symptoms (including abdominal pain, cramping, bloating and gas) after a lactose challenge, comparing baseline symptom scores to 30-days post-treatment symptom scores to assess patients’ clinically meaningful benefit.
• Secondary endpoints: Will evaluate LI signs and symptoms and global assessment outcomes to evaluate and assess a patient’s continued meaningful treatment benefit.
“We are pleased with the productive discussion and open dialog we had with the FDA regarding our Phase 3 plans,” said Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, Inc. “We are confident we can execute a successful Phase 3 program furthering our goal to ultimately file a successful NDA and commercialize RP-G28 as the first FDA-approved treatment for lactose intolerance.”
RP-G28 is a novel, non-digestible oligosaccharide of ultra-high purity developed to modulate the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal tract to metabolize lactose to improve lactose tolerance. One 30-day course treatment is expected to allow for durable treatment benefit.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. Its lead product, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions worldwide. 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.