LOS ANGELES—Today Ritter Pharmaceuticals, Inc., a developer of novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases, announced that it has signed an agreement with the clinical research organization (CRO) Medpace Inc. to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).
Ritter’s initial focus is on the development of the first FDA-approved treatment for lactose intolerance. RP-G28 has been studied in Phase 2 trials, and is expected to commence Phase 3 clinical development in the second quarter of 2018. Ritter Pharmaceuticals is exploring the therapeutic potential that gut microbiome changes may have on treating and/or preventing a variety of diseases, including gastrointestinal diseases, cancer, metabolic and liver disease.
“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 3 study. With our CRO partner secured, we remain on track to initiate our RP-G28 Phase 3 trial this quarter.”
With support from Medpace, Ritter Pharmaceuticals will conduct a multicenter randomized double-blind placebo-controlled parallel-group trial in the United States, in approximately 525 patients. This trial aims to evaluate the efficacy, safety, durability, and tolerability of RP-G28 in patients with lactose intolerance.
The primary objective of the study is to assess the efficacy of RP-G28 compared to placebo on the reduction from baseline of LI symptoms, following 30 days of treatment and 30 days of real-world lactose consumption. Secondary objectives include assessments of the safety and tolerability of treatment with RP-G28, the durability of effect of treatment on LI symptoms after 3 months of lactose consumption, and the response over time on patient-reported outcomes and global assessment measures.
“Medpace is pleased to have been chosen by Ritter Pharmaceuticals to conduct its Phase 3 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.”