SOURCE: Ritter Pharmaceuticals, Inc.

March 21, 2016 06:00 ET

Ritter Pharmaceuticals Doses First Patient in Phase 2b/3 Trial of RP-G28 in Lactose Intolerance

LOS ANGELES, CA--(Marketwired - Mar 21, 2016) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or the "Company"), a leading developer of novel therapeutics that modulate the human gut microbiome to treat gastrointestinal diseases, today announced the dosing of the first patient in its Phase 2b/3 clinical trial of RP-G28 for the treatment of lactose intolerance.

Andrew J. Ritter, Founder and President of Ritter Pharmaceuticals, stated, "We are pleased to have initiated dosing in the Phase 2b/3 clinical trial of our lead product candidate, RP-G28 for the treatment of lactose intolerance. This puts us on the path towards potential commercialization of the first FDA-approved drug for this indication."

Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue University and Chair of Ritter Pharmaceuticals' medical board, further stated, "Millions of Americans and many more worldwide suffer from this condition with few treatment options available. This study will assist in the development of a medication that may help many people around the globe who suffer from lactose intolerance."

The Phase 2b/3 trial is a double-blind, placebo-controlled, multicenter study to determine the efficacy and safety of two RP-G28 dosing regimens on symptoms related to lactose intolerance relative to placebo treatment. Approximately 350 patients will be randomized at up to 20 locations within the United States. Patients will undergo a 30-day treatment process, followed by a 30-day post-treatment evaluation where dairy will be included back into the diet. In addition, the study will further evaluate participant's microbiome, expanding knowledge of the effects RP-G28 may have on positively adapting and shifting the gut microbiota for health benefits. The company expects top-line data by early 2017.

One can learn more about participating in the clinical trial at www.LactoseTrial.com or by calling toll-free 877-852-9598.

About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company is advancing human gut health research by exploring the metabolic capacity of the gut microbiota, and translating the functionality of these microbiome modulators into safe and effective applications. Their lead drug candidate, RP-G28, has the potential to become the first FDA-approved drug for lactose intolerance, a condition that affects more than one billion people worldwide.

Forward-Looking Statements
This release may contain forward-looking statements, which express the current beliefs and expectations of Ritter Pharmaceuticals' management. Such statements involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information