Ritter Pharmaceuticals Concludes Last Patient Visit of Its Phase 2b/3 Clinical Trial of RP-G28 for the Treatment of Lactose Intolerance

LOS ANGELES, CA--(Oct 17, 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 the last patient has completed dosing and all monitoring visits in its Phase 2b/3 clinical trial of RP-G28 for the treatment of lactose intolerance. Topline results of the trial are expected to be announced in the first quarter of 2017.

 

Andrew J. Ritter, Co-Founder and President of Ritter Pharmaceuticals stated, "We are pleased to have met our timeline and concluded the dosing of our investigational drug in 377 patients. This significant milestone brings us one step closer to data read-out and reporting. Considering the enormous population of over 40 million individuals in the United States that suffer from lactose intolerance and the lack of sufficient treatment options, we are eager to establish our therapeutic product as potentially the first FDA-approved treatment for this condition."

 

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 RP-G28 in patients with moderate to severe lactose intolerance symptoms. Enrollment was initiated in March of 2016 and completed in August 2016, achieving the company's projected enrollment time period. 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 underwent a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance [1]. 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.

 

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.

 

Forward-Looking Statements

 

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.

 

[1] Additional information on the study is available at:

https://clinicaltrials.gov/ct2/show/NCT02673749?term=lactose+intolerance&rank=6