LOS ANGELES, Feb. 28, 2019 (GLOBE NEWSWIRE) -- Ritter Pharmaceuticals, Inc. (RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases (GI) with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance (LI), today recaps remarks made by Dr. William Chey, Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan in an expert call hosted by the Company. The full transcript and audio replay of the call is available at: https://www.ritterpharmaceuticals.com/investors/events-presentations
During the call, Dr. Chey discussed the prevalence of LI in the United States: approximately 40 million Americans are affected with LI, and roughly nine million are affected moderately to severely1. Dr. Chey discussed the benefit of RP-G28 given the drawbacks of the currently available LI treatment options such as dairy avoidance and the use of lactase supplements. Dr. Chey explained that dairy avoidance can prove difficult given that many Americans consume processed food where lactose is hidden. Additionally, lactase supplements are dose dependent and challenging for the average person to determine the appropriate dosage.
Dr. Chey continued by describing RP-G28’s Phase 2 trial results. As Dr. Chey remarked: “the nice thing about this data set is that they've evaluated the data in a variety of different ways. The thing that's exciting about it is the consistency of the response. Regardless of whether you're looking at those composite or individual lactose intolerance symptoms, or milk and dairy consumption, or a more global assessment, like, adequate relief, for example, or satisfaction with the treatment, all of these different sets of endpoints are going in the same direction, which to me is very promising.”
Dr. Chey went on to discuss the Phase 3 program planned for RP-G28, including its first Phase 3 trial, known as “Liberatus” currently underway. He discussed the close cooperation between the Company and the FDA on determining endpoints and overall trial design. Additionally, Dr. Chey voiced optimism regarding the current regulatory environment as a number of GI drugs with similar patient reported outcomes-based endpoints have recently been approved by the FDA.
Dr. Chey added that by supporting the growth of bacteria strains necessary to address a specific disease state, selective “prebiotics” such as RP-G28 represent a possibly game-changing approach to addressing lactose intolerance as well as other diseases. “To me, that's the really exciting part of this whole thing; to see if this strategy of manipulating the microbiome to affect symptoms of lactose intolerance holds true. Because if it does, this could be the beginning of something really big.”
Ritter Pharmaceuticals expects completion and data readout of its first pivotal phase 3 trial in lactose intolerance during the second half of 2019. The 525-subject multicenter, randomized, double-blind, placebo-controlled, parallel-group study continues to enroll on-time and is expected to fully enroll very soon. To learn more about the Liberatus study visit www.clinicaltrials.gov (NCT03597516) or www.liberatusstudy.com/clinical-research.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.ritterpharma.com, @RitterPharma) develops innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company’s lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions worldwide. RP-G28 is in Phase 3 clinical development with its first Phase 3 clinical trial, known as “Liberatus,” currently underway. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including: gastrointestinal diseases, cancer, metabolic, and liver disease.
About Dr. William Chey
Dr. Chey is Nostrant Collegiate Professor of Gastroenterology & Nutrition Sciences, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at Michigan Medicine. Dr. Chey is a member of the Company’s medical advisory board. He also serves as a 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 Disorders. Dr. Chey has authored more than 300 manuscripts, reviews and book chapters, and he was the Co-Editor-in-Chief of the American Journal of Gastroenterology from 2010 to 2015. He has been elected to “Best Doctors” since 2001 and “America’s Top Doctors” since 2009. Dr. Chey has been inducted into the Clinical Excellence Society of the Department of Medicine, received the Dean’s Outstanding Clinician Award, was inducted into the League of Research Excellence at the University of Michigan and has received the Distinguished Clinician Award from the American Gastroenterological Association. Dr. Chey received his B.A. from the University of Pennsylvania and medical degree and training in internal medicine at the Emory University School of Medicine, completing his fellowship in gastroenterology at the University of Michigan.
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals’ management. Any statements contained herein that do not describe historical facts are forward-looking statements, including statements related to our anticipated timing for achieving full enrollment in our Liberatus study, completion of the Liberatus study and our release of data from the study. Forward-looking statements are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Ritter cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.
1 NIH Consensus Statement, LIH, Vol. 27 #2 (February 2010); Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance and RP-G28,” p. 4 and 7 (June 2012)