Ritter Pharmaceuticals, a U.S. developer of novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of the first FDA-approved treatment for lactose intolerance, signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).
Medpace is a scientifically driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
With support from Medpace, Ritter Pharmaceuticals will conduct a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial, in approximately 525 patients to evaluate the efficacy, safety, durability, and tolerability of RP-G28 in patients with lactose intolerance (LI). 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.
Ritter Pharmaceuticals develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The company’s lead product candidate, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of people worldwide. RP-G28 has been studied in Phase 2 trials, and is expected to commence Phase 3 clinical development in the second quarter of 2018.