Ritter Pharmaceuticals Announces Lactose Intolerance Treatment, RP-G28, Demonstrated Efficacy and Clinically Meaningful Benefit in Phase 2b/3 Clinical Trial

LOS ANGELES, CA--(Marketwired - Mar 28, 2017) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR)

• Data Supports Further Clinical Development into Phase 3
• Conference call and webcast at 9 a.m. EDT, March 29, 2017

Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company") today announced topline findings from its Phase 2b/3 study designed to evaluate RP-G28 in subjects with lactose intolerance. Results from the 377-subject trial show a clinically meaningful benefit to subjects in the reduction of lactose intolerance symptoms across a variety of outcome measures. The majority of analyses showed positive outcome measures and the robustness of the data point to a clear drug effect. Based on these trial results, the Company believes that the successful completion of a confirmatory Phase 3 program could be adequate to support a New Drug Application (NDA) submission and therefore has requested an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

About the Trial and RP-G28

The Phase 2b/3, multi-center, randomized, doubled-blind, placebo-controlled, parallel-group study was designed to determine the efficacy, safety, and tolerability of two dosing regimens of RP-G28 in subjects with lactose intolerance. RP-G28 is a novel, non-digestible oligosaccharide of ultra-high purity developed to modulate the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal (GI) tract to metabolize lactose to improve lactose tolerance. The pre-specified primary endpoint was the proportion of subjects who were abdominal symptom responders comparing the two active dose groups combined versus placebo using a two-sided test at the alpha=0.05 level of significance. An abdominal symptom responder represents a clinically meaningful reduction, defined, as a subject showing lessening of a composite symptom score comprised of abdominal pain, abdominal cramping, abdominal bloating and gas movement.

Primary Endpoint

The primary endpoint established in this trial focused on defining and best quantifying a clinically meaningful benefit to patients suffering from lactose intolerance to support product approval and labeling claims. This endpoint was discussed with the FDA in a Type C informational meeting prior to un-blinding the data and incorporates the agency's recommendations.