LOS ANGELES, June 20, 2019 (GLOBE NEWSWIRE) -- Ritter Pharmaceuticals, Inc. (RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of innovative therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first Food and Drug Administration (FDA)-approved treatment for lactose intolerance (LI), today provided an update of its Phase 3 clinical trial and regulatory efforts.
- The 557-subject Phase 3 clinical trial of RP-G28, known as “Liberatus”, remains on track with anticipated top-line data readout in early Q4 2019. As previously reported, all subjects have completed enrollment with last-patient-last-visit expected in July 2019. The study remains blinded and unblinding and analysis of the data will not take place until patients have completed all protocol periods and the database has been locked.
- The Company has been in dialog with the FDA to confirm that the analyses defined in the Statistical Analysis Plan (SAP) for the Liberatus Phase 3 clinical trial would be supported by the FDA. The Company has achieved alignment over key elements of the study’s SAP, including the primary endpoint, secondary endpoints and other critical components.
“We are pleased with our most recent interactions with the FDA, we understand their clinical and regulatory priorities and expectations going into our upcoming data readout,” said Andrew J. Ritter, CEO of Ritter Pharmaceuticals. “We expect that the feedback and agreements reached with the FDA will result in a high-quality analysis of the Liberatus data.”
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 LI. Participants underwent a 2-week screening period, followed by a randomized 30-day study drug treatment period (RP‑G28 or placebo), then 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 from baseline of the lactose intolerance 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 of 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 with top-line data expected in early Q4 2019. 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 may contain 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 clinical trial, our release of data from the study, expected trial results, the funding and timing of future clinical studies, interactions and comments related to the FDA and our regulatory strategy and SAP. 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. The Company 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.