LOS ANGELES (August 15, 2016) – Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that it has completed patient enrollment on schedule for its Phase 2b/3 clinical trial of its investigational compound RP-G28 for the treatment of lactose intolerance. Topline results of the trial are expected to be announced in the first quarter of 2017.
The Phase 2b/3 trial is a double-blind, placebo-controlled, three arm, multicenter study evaluating safety, efficacy and tolerability of two dosing regimens of its investigational compound RP-G28 in patients with moderate to severe lactose intolerance symptoms. Enrollment was initiated in March of 2016 and completed within 6-months, achieving the company’s projected enrollment milestones. The study aims to evaluate a patient’s ability to consume dairy foods post-treatment with improved tolerance and reduced digestive symptoms. A total of 377 subjects were enrolled in the trial with 18 clinical sites participating throughout the United States. Patients undergo a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance  . In addition, the study will evaluate each participant’s microbiome, expanding knowledge of the effects that RP-G28 may have on adapting the gut microbiota in a beneficial manner.
Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue University and Chairman of Ritter Pharmaceuticals’ medical advisory board, further stated, “the rapid speed of recruitment and sheer number of patients requesting participation in the trial demonstrates that lactose intolerant individuals are actively seeking options to treat embarrassing and often painful symptoms associated with this condition.
William Sandborn, M.D., Chief and Professor, Division of Gastroenterology and Director at UCSD Inflammatory Bowel Disease Center, further added, “It is exciting to see rapid progress in a large human clinical study involving the microbiome in a GI condition. We feel the knowledge gained from exploring our study’s microbiome data could be beneficial in a number of diseases.”
Andrew J. Ritter, Founder and President of Ritter Pharmaceuticals, added, “we are delighted to have successfully met our enrollment target on schedule. I would like to recognize our clinical sites for their hard work and diligence in helping us achieve our goals. Completion of enrollment marks an important milestone in our pursuit of the first FDA-approved treatment for lactose intolerance which may help the over 60 million Americans and globally millions more who suffer from this condition.”
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 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.
This release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our release of topline results from our Phase 2b/3 clinical trial of RP-G28. Management believes that these forward-looking statements are reasonable as and when made. However, 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. These risks and uncertainties include, but are not limited to, risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process. For a discussion of certain risks and uncertainties affecting Ritter Pharmaceuticals’ forward-looking statements, please review the Company’s reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2015 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2016 and June 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management’s current expectations and Ritter Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.