Ritter Pharmaceuticals, Inc. (Nasdaq: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases, today announced that the last patient has completed their final visit in the Company’s first pivotal Phase 3 clinical trial of RP-G28 for the potential treatment of lactose intolerance (LI), a study known as “Liberatus” (NCT03597516).
- The 557-subject clinical trial began enrollment in late June 2018 and completed on-time in just over a year. Trial finalization leading to data lock and top-line data readout has now begun.
- Top-line data readout remains on track for early Q4 2019
- As recently reported, the Company has achieved alignment with the Food and Drug Administration (FDA) over key elements of the Liberatus statistical analysis plan including the primary endpoint, secondary endpoints and other critical components.
“RP-G28 is potentially a breakthrough therapy for patients with LI as there are few effective treatment options available today.”
“The novel mode of action of RP-G28 based on gut modulation has shown great promise and I’m encouraged by this study’s potential to validate the capabilities of gut microbiome modulating therapies while also evaluating relevant clinical outcomes.”
said William J. Sandborn, M.D, Chief of the Division of Gastroenterology at the University of California, San Diego and Medical Advisor to Ritter Pharmaceuticals,
“With the unblinding and topline data readout imminent, we hope to demonstrate that one, 30-day course of treatment with RP-G28 improves tolerance to dairy products in those suffering from LI, ultimately enabling patients to be able to enjoy dairy foods without worrying about the often bothersome and embarrassing symptoms of LI,”
said Andrew J. Ritter, CEO of Ritter Pharmaceuticals.
About Phase 3 Liberatus Clinical Trial
The Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group Liberatus clinical trial was designed to determine the efficacy, safety and tolerability of RP-G28 to treat lactose intolerance. Participants underwent a 2-week screening period, followed by a randomized 30-day study drug treatment period (RP‑G28 or placebo). Then participants were followed for a 90-day “real-world experience” period to assess study drug response and durability of effect after treatment as patients consume their normal diets, including dairy products. The primary endpoint in this study compares RP-G28 to placebo on the reduction of the lactose intolerance symptom composite score at Day 61, comprised of 30 days of treatment and 30 days of real-world lactose exposure. Secondary endpoints evaluate patients’ continued treatment benefit for 90 days following treatment. The study utilizes prior validated symptom assessment measures and real-time, electronic data capture of patient experiences to document relevant outcomes. In addition, risk-based data review is being conducted through an electronic, centrally-monitored database to assess potential protocol deviations and site quality indicators. The study remains blinded to all participants and while all patients have completed all protocol periods, analysis of the data will not take place until the database has been locked.