Ritter Pharmaceuticals Highlights Key Phase 2b Clinical Trial Data of RP-G28 for Lactose Intolerance at Digestive Disease Wee...
June 05 2018 - 8:30AM
Additional Data Describes Novel Clinical
Symptom Assessment Tool Developed in Phase 2b Trial and to be Used
in Upcoming Phase 3 Clinical Trial
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
PharmaceuticalsRitter 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 StatementsThis 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.
Contacts
Investor Contact:
John Beck
310-203-1000
john@ritterpharma.com
Media Contact:
Jules Abraham
CoreIR
917-885-7378
julesa@coreir.com
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