Ritter Pharma Selects Medpace for Phase III Trials

Ritter Pharmaceuticals, Inc., a developer of novel therapeutics to treat gastrointestinal diseases, has signed an agreement with Medpace to conduct the first of two pivotal Phase III clinical trials for RP-G28 in patients with lactose intolerance (LI).

With support from Medpace, Ritter will conduct a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in the U.S., in approximately 525 patients to evaluate the efficacy, safety, durability, and tolerability of RP-G28 in patients with LI. The primary objective is to assess the efficacy of RP-G28 compared to placebo on the reduction of LI symptoms following 30 days of treatment and 30 days of real-world lactose consumption. Secondary objectives include assessments of the safety, tolerability and durability of effect of treatment on LI symptoms after 3 months of lactose consumption.

“Our team has worked diligently to identify and select the right CRO partner to execute our pivotal Phase 3 clinical trial for RP-G28,” said Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, Inc. “Medpace is an established, highly regarded full-service Phase I-IV CRO with expertise in numerous therapeutic areas that is focused on supporting the biotech and pharmaceutical industry. It is a scientifically-driven organization with a dedicated in-house study team and clinical research physician support. Medpace has an extensive portfolio of successfully completed late-stage clinical programs supporting NDA filings, including programs with patient-reported outcomes like ours. Medpace is our ideal CRO choice as they provide the experience and range of services to competently execute our Phase III study.”

“Medpace is pleased to have been chosen by Ritter Pharmaceuticals to conduct its Phase III study for RP-G28,” said Susan Burwig, executive vice president, Operations at Medpace. “Our team has the appropriate therapeutic experience in conducting clinical trials in the area of gastrointestinal diseases. We look forward to partnering with Ritter Pharmaceuticals and utilizing our knowledge and experience in the GI and microbiome fields to execute this pivotal trial.”