Additional Data Describes Novel Clinical Symptom Assessment Tool Developed in Phase 2b Trial and to be Used in Upcoming Phase 3 Clinical Trial
LOS ANGELES, June 05, 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 presented highlighted data and additional insights from its previously completed Phase 2b trial of RP-G28 in two posters at Digestive Disease Week, 2018 in Washington, D.C.
“This study was one of the largest double-blind randomized studies ever conducted in lactose intolerance,” commented Dennis Savaiano, Ph.D. professor, Department of Nutrition Science, Purdue University and one of the leading lactose intolerance experts in the U.S., “Each of these posters provides insight into the potential clinical meaningfulness of RP-G28 on treating patients with LI.”
Posters:
The first poster highlights RP-G28’s treatment benefit in safely and effectively reducing or eliminating key symptoms of LI, while the second outlines the development and validation of a novel tool to measure changes in the severity of LI symptoms over time and shows the instrument’s reliability and responsiveness, illustrating its utility for evaluating treatment intervention effects.
“Improvement of Clinical Symptoms of Lactose Intolerance with a Novel Galacto-Oligosaccharide, RP-G28”
This poster, presented today, highlights key efficacy and safety assessments seen in a recently completed Phase 2b 377-subject study of RP-G28 vs. placebo in treating lactose intolerance. Across multiple endpoints, a 30-day course of RP-G28 significantly improved overall and individual LI symptoms and patients in the study reported positive experiences and feelings towards treatment benefit.
The primary endpoint demonstrated that 40 percent of RP-G28 treated-patients reported a meaningful improvement of their LI symptoms, compared to 26 percent of placebo patients (p=0.016), after excluding one study site due to significant irregularities demonstrated at that site. Further, there was a statistically significant difference between groups of those who reported complete elimination of abdominal pain (p=0.014), cramping (p=0.002), bloating (p=0.015) and gas movement (p=0.001). Multiple global assessment scales, including symptom severity (p=0.001), adequate relief (p=0.042), satisfaction (p=0.030) and symptom improvement (p=0.034) assessed through patient questionnaires 30-days after treatment, reported statistically significant improved results as well. This poster demonstrates that RP-G28 may offer a potentially novel treatment for patients with LI.
“A Novel Tool to Assess Symptoms of Lactose Intolerance and Define Meaningful Patient Benefit”
This poster, presented yesterday, June 4th, 2018, describes the development of a patient-reported LI symptom questionnaire, which is able to assess a patient’s response to treatment in a clinical trial. The tool, validated in our recently completed Phase 2b clinical trial of RP-G28 contains 4-items that contribute to a composite score; each item measuring a key symptom of LI (i.e., pain, cramping, bloating and gas movement) on an 11-point numerical response scale. The questionnaire and composite score were shown to be reliable, valid, and responsive in measuring LI change symptom severity. Further, the tool can be correlated to a patient-focused endpoint in LI clinical trials in being able to measure a “meaningful treatment benefit,” as well as for assessment of LI symptom severity in clinical practice.
“Together, these posters provide additional support for our upcoming Phase 3 program of RP-G28 in that we now have a validated tool to reliably measure patients’ symptom severity and correlate symptom improvement to what is a meaningful benefit to the patient,” said Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, Inc. “We look forward to beginning our first Phase 3 pivotal trial of RP-G28 for the treatment of LI.”
About Digestive Disease Week
Highlighting the most relevant, up-to-date and cutting-edge science, Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT). In 2018, it is held from June 2-5 in Washington, D.C.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel 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 of people worldwide. RP-G28 has been studied in Phase 2 trials, and is now in Phase 3 clinical development. 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.
Forward-Looking Statements
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, including statements regarding the timing and commencement of our first Phase 3 clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that 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. 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. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.