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Understanding the Unmet Medical Need in Lactose Intolerance Patients and the Potential of RP-G28, Currently in a Phase 3 TrialTicker(s): RTTR
Name: Dr William Chey
Institution: University of Michigan
Director of the Gastrointestinal Physiology Lab at Michigan Medicine.
Member of the Board of Trustees of the American College of Gastroenterology, the Board of Directors of the Rome Foundation, and a member of the Advisory Board of the International Foundation of Functional GI Disorder.
Authored more than 300 manuscripts, reviews and book chapters, and was the Co-Editor-in-Chief of the American Journal of Gastroenterology from 2010 to 2015.
- Member of Ritter Pharmaceutical’s medical advisory board.
Ritter Pharmaceuticals is an LA-based, publicly traded company developing potentially the first FDA-approved treatment for lactose intolerance, RP-G28. RP-G28 is now in Phase 3 trials with the first pivotal study underway. In December 2018, Ritter Pharmaceuticals announced that it had reached the halfway mark enrollment in this study, known as “Liberatus”, and expects data readout in h2 2019. Liberatus is a double-blinded, placebo controlled, 525-subject, multi-centered U.S. only study
What is your experience and involvement with RP-G28 and Ritter Pharmaceuticals?Added By: joe_mccann
Please describe your clinical practice. How are patients currently diagnosed with LI?
- How big of an issue is LI in your practice?
- How satisfied with these treatments are your patients?
- What is the breakdown of severe, moderate and mild patients you see?
Moving into RP-G28's profile which is a non-digestible oligosaccharide designed to selectively stimulate growth of lactose metabolizing colonic bacteria in the gut. The product is taken for 30 days and thereafter patients experience reduced or no symptoms when consuming dairy foods.
- What role does the microbiome play in Lactose Intolerance?
- Why would a Prebiotic approach be a better strategy than a Probiotic approach in addressing LI?
- What do you see as the treatment benefit RP-G28 provides LI patients?
- The Phase 3 study uses a symptom composite score comprised of abdominal pain, bloating, gas and cramping as the primary endpoint.
- What is your view of this test's ability to measure a patient's response to study treatment?
- What is your view of this test's ability to measure a patient response to study treatment - Is a 4-point or greater reduction in a patient's LI composite score meaningful to you? Your Patients?
What is your overall assessment of the of the Phase 2b data?
- Thoughts on the primary endpoint as measured by the symptom composite score, placebo vs. treatment response
- What are your thoughts on the phase 2b data?
On a scale of 1-10 how optimistic about the Phase 3 trial being positive are you? If the Phase 3 trials are positive and the drug is approved, how excited on a scale of 1-10 would you be for your LI patients?Added By: joe_mccann
What is your view of the current regulatory environment for GI product candidates in general and RP-G28 for LI specifically?Added By: joe_mccann
What is your opinion on durability of effect of a product that induces a change in metabolic activity or type of intestinal bacteria. Please estimate likelihood that those patients who gain beneficial effect on LI symptom control during short term treatment will have sustained benefit. Durability of effect may be regulatory concern; should this be addressed in Phase 3?
Added by D Earnest
have you considered the interaction between the lactase enzyme and alcohol? Alcohols tend to deactivate enzymes. In taking the lactase enzyme supplement orally, the lactose then interacts with the enzyme in the stomach where the alcohol may be present. Could drinking alcohol lessen the impact the lactase enzyme could have?
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