Dr. William Chey Highlights Unmet Medical Need of Lactose Intolerance and Potential for Phase 3 Drug Candidate RP-G28 in Expe...
February 28 2019 - 8:30AM
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 (GI) 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 recaps remarks made by Dr. William Chey, Professor of
Medicine, Director of the GI Physiology Laboratory, and Co-Director
of the Michigan Bowel Control Program at the University of Michigan
in an expert call hosted by the Company. The full transcript and
audio replay of the call is available at:
https://www.ritterpharmaceuticals.com/investors/events-presentations
During the call, Dr. Chey discussed the
prevalence of LI in the United States: approximately 40 million
Americans are affected with LI, and roughly nine million are
affected moderately to severely1. Dr. Chey discussed the benefit of
RP-G28 given the drawbacks of the currently available LI treatment
options such as dairy avoidance and the use of lactase supplements.
Dr. Chey explained that dairy avoidance can prove difficult given
that many Americans consume processed food where lactose is hidden.
Additionally, lactase supplements are dose dependent and
challenging for the average person to determine the appropriate
dosage.
Dr. Chey continued by describing RP-G28’s Phase
2 trial results. As Dr. Chey remarked: “the nice thing about this
data set is that they've evaluated the data in a variety of
different ways. The thing that's exciting about it is the
consistency of the response. Regardless of whether you're looking
at those composite or individual lactose intolerance symptoms, or
milk and dairy consumption, or a more global assessment, like,
adequate relief, for example, or satisfaction with the treatment,
all of these different sets of endpoints are going in the same
direction, which to me is very promising.”
Dr. Chey went on to discuss the Phase 3 program
planned for RP-G28, including its first Phase 3 trial, known as
“Liberatus” currently underway. He discussed the close cooperation
between the Company and the FDA on determining endpoints and
overall trial design. Additionally, Dr. Chey voiced optimism
regarding the current regulatory environment as a number of GI
drugs with similar patient reported outcomes-based endpoints have
recently been approved by the FDA.
Dr. Chey added that by supporting the growth of
bacteria strains necessary to address a specific disease state,
selective “prebiotics” such as RP-G28 represent a possibly
game-changing approach to addressing lactose intolerance as well as
other diseases. “To me, that's the really exciting part of this
whole thing; to see if this strategy of manipulating the microbiome
to affect symptoms of lactose intolerance holds true. Because if it
does, this could be the beginning of something really big.”
Ritter Pharmaceuticals expects completion and
data readout of its first pivotal phase 3 trial in lactose
intolerance during the second half of 2019. The 525-subject
multicenter, randomized, double-blind, placebo-controlled,
parallel-group study continues to enroll on-time and is expected to
fully enroll very soon. To learn more about the Liberatus study
visit www.clinicaltrials.gov (NCT03597516) or
www.liberatusstudy.com/clinical-research.
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.
About Dr. William Chey
Dr. Chey is Nostrant Collegiate Professor of
Gastroenterology & Nutrition Sciences, Director of the GI
Physiology Laboratory, and Co-Director of the Michigan Bowel
Control Program at Michigan Medicine. Dr. Chey is a member of the
Company’s medical advisory board. He also serves as a member of the
Board of Trustees of the American College of Gastroenterology, the
Board of Directors of the Rome Foundation and a member of the
Advisory Board of the International Foundation of Functional GI
Disorders. Dr. Chey has authored more than 300 manuscripts, reviews
and book chapters, and he was the Co-Editor-in-Chief of the
American Journal of Gastroenterology from 2010 to 2015. He has been
elected to “Best Doctors” since 2001 and “America’s Top Doctors”
since 2009. Dr. Chey has been inducted into the Clinical Excellence
Society of the Department of Medicine, received the Dean’s
Outstanding Clinician Award, was inducted into the League of
Research Excellence at the University of Michigan and has received
the Distinguished Clinician Award from the American
Gastroenterological Association. Dr. Chey received his B.A. from
the University of Pennsylvania and medical degree and training in
internal medicine at the Emory University School of Medicine,
completing his fellowship in gastroenterology at the University of
Michigan.
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. 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.
ContactsInvestor Contact:John Beck 310-203-1000
john@ritterpharma.com
Media Contact:Jules Abraham
CoreIR917-885-7378julesa@coreir.com
1 NIH Consensus Statement, LIH, Vol. 27 #2 (February 2010);
Objective Insights, “Market Research Analysis and Forecasts on
Lactose Intolerance and RP-G28,” p. 4 and 7 (June 2012)
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