Full Enrollment on Target for Q2 2019 with Data Readout Expected in the Second Half of 2019
LOS ANGELES, Dec. 04, 2018 (GLOBE NEWSWIRE) -- 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 with an initial focus on the development of RP-G28, a drug candidate with the potential to be the first FDA-approved treatment for lactose intolerance (LI), today announced that it has passed the 50 percent enrollment point in its first pivotal Phase 3 clinical trial of RP-G28 for the potential treatment of LI, a study known as the “Liberatus” study.
“We are pleased to have achieved this important milestone in study enrollment and we remain on track with our projected timeline for the completion of the Liberatus study in the second half of 2019,” said Andrew J. Ritter, CEO of Ritter Pharmaceuticals. “RP-G28 has the potential to be the only FDA-approved, pharmaceutical solution to treat lactose intolerance, a condition afflicting more than 40 million people in the United States and millions more worldwide. We look forward to sharing the Liberatus study results with patients, medical professionals and our investors next year.”
To date, 267 of the expected 525 study subjects have been enrolled in the Liberatus study, with 79 percent (23 out of 29) of the active screening clinical sites having enrolled at least one study subject. For high-enrolling sites, total patient enrollment is capped to ensure reasonable distribution among sites. The demographic profile of the study subjects enrolled thus far in the study is trending consistent with the Phase 2 program’s study population, which was completed in 2017. Full enrollment is expected to be achieved during the second quarter of 2019, with data readout during the second half of 2019. Persons interested in participating in the Liberatus study may receive more information by visiting www.clinicaltrials.gov (NCT03597516) or visit www.liberatusstudy.com/clinical-research.
The 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 undergo a 2-week screening period, followed by a randomized 30-day study drug treatment period and 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 is the mean change in LI symptom composite score 30-days post-treatment compared to baseline. Secondary endpoints evaluate LI signs and symptoms and global assessment outcomes to evaluate patients’ continued treatment benefit. The study utilizes the prior validated symptom assessment measure 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.
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 millions 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 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 achieving full enrollment in our Liberatus study, completion of the Liberatus study and our release of data from the study. 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.