Ritter Pharmaceuticals Completes Dosing of Last Patient in Pivotal 557-Subject Phase 3 Clinical Trial

Ritter Pharmaceuticals (NASDAQ:RTTR) has announced that the final patient in its pivotal Phase 23 trial of RP-G28 trial to treat lactose intolerance has finished the 30 day treatment dosing period.

As quoted in the press release:

“We are excited to announce that the last of the 557 enrolled patients in our Liberatus trial has completed dosing and we remain on track for data readout in early Q4 2019,” said Andrew J. Ritter, CEO of Ritter Pharmaceuticals. “With patient completion of the 30-day treatment period, approximately 43%, or 240 patients are continuing at various points through the 90-day “real-world” observational portion of the trial, while approximately 50%, or 280 subjects have completed the trial. To date, we project the rate of patients lost to follow-up or dropout to be approximately or below 10% of the study population. No safety signals have been reported to date which continues to support the well-tolerated safety and tolerability profile we have observed in earlier clinical studies.”

The Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group Liberatus study was designed to determine the efficacy, safety and tolerability of RP-G28 to treat LI. Participants underwent a 2-week screening period, followed by a randomized 30-day study drug treatment period (RP‑G28 or placebo) followed by 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. Aligning with FDA guidance, the primary endpoint in this study compares RP-G28 to placebo on the reduction from baseline of the lactose intolerance (LI) symptom composite score at Day 61 after 30 days of treatment and 30 days of real-world lactose exposure. Secondary endpoints evaluate LI signs and symptom outcomes to evaluate patients’ continued treatment benefit. The study utilizes prior validated symptom assessment measures and real-time, electronic data capture of patient questionnaires 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 analysis of the data will not take place until all patients have completed all protocol periods and the data base has been locked.

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