05/07/2019 | Press release | Distributed by Public on 05/07/2019 16:48
Top-line Data Readout on Target for early Q4 2019
LOS ANGELES(May 7, 2019) - 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 final patient in its first pivotal Phase 3 clinical trial of RP-G28 for the potential treatment of Lactose intolerance (LI), a study known as the "Liberatus" study (NCT03597516), has completed the 30-day treatment dosing period.
"We are excited to announce that the last of the 557 enrolled patients in our Liberatus trial has completed dosingand 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.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops innovative 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 over one billion people worldwide. RP-G28 is in Phase 3 clinical development with its first Phase 3 clinical trial, known as "Liberatus," currently underway. The Company is further exploring the therapeutic potential that gut microbiome changes may have on treating/preventing a variety of diseases including gastrointestinal diseases, cancer, metabolic, and liver disease.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of Ritter Pharmaceuticals' management. Any statements contained herein that do not describe historical facts are forward-looking statements, including statements related to our anticipated timing for completion of the Liberatus study, our release of data from the study, expected trial results and the funding and timing of future clinical studies. Forward-looking statements are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Some of the factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Ritter cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date they were made. The Company undertakes no obligation to update or revise forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.