Ritter Pharmaceuticals Announces Last Patient Last Visit in its Phase 3 “Liberatus” Clinical Trial of RP-G28 for Lactose ...
2019年7月2日 - 10:00PM
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, today announced that the last patient
has completed their final visit in the Company’s first pivotal
Phase 3 clinical trial of RP-G28 for the potential treatment of
lactose intolerance (LI), a study known as “Liberatus”
(NCT03597516).
- The 557-subject clinical trial
began enrollment in late June 2018 and completed on-time in just
over a year. Trial finalization leading to data lock and top-line
data readout has now begun.
- Top-line data readout remains on
track for early Q4 2019
- As recently reported, the Company
has achieved alignment with the Food and Drug Administration (FDA)
over key elements of the Liberatus statistical analysis plan
including the primary endpoint, secondary endpoints and other
critical components.
“RP-G28 is potentially a breakthrough therapy
for patients with LI as there are few effective treatment options
available today,” said William J. Sandborn, M.D, Chief of the
Division of Gastroenterology at the University of California, San
Diego and Medical Advisor to Ritter Pharmaceuticals, “The novel
mode of action of RP-G28 based on gut modulation has shown great
promise and I’m encouraged by this study’s potential to validate
the capabilities of gut microbiome modulating therapies while also
evaluating relevant clinical outcomes.”
“With the unblinding and topline data readout
imminent, we hope to demonstrate that one, 30-day course of
treatment with RP-G28 improves tolerance to dairy products in those
suffering from LI, ultimately enabling patients to be able to enjoy
dairy foods without worrying about the often bothersome and
embarrassing symptoms of LI,” said Andrew J. Ritter, CEO of Ritter
Pharmaceuticals.
About Phase 3 Liberatus Clinical
TrialThe 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 lactose intolerance. Participants underwent a
2-week screening period, followed by a randomized 30-day study drug
treatment period (RP‑G28 or placebo). Then participants were
followed for 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 of the lactose intolerance symptom composite score at Day
61, comprised of 30 days of treatment and 30 days of real-world
lactose exposure. Secondary endpoints evaluate patients’ continued
treatment benefit for 90 days following treatment. The study
utilizes prior validated symptom assessment measures and real-time,
electronic data capture of patient experiences 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 while all patients
have completed all protocol periods, analysis of the data will not
take place until the database has been locked.
About Ritter
PharmaceuticalsRitter 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 in its finalization stage 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.
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. Any statements contained herein that
do not describe historical facts are forward-looking statements,
including statements related to our anticipated timing for the
release of data from our Liberatus clinical trial, expected trial
results, the funding and timing of future clinical studies,
interactions and comments related to the FDA and our regulatory
strategy and statistical analysis plan. 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.
ContactsInvestor Contact: John Beck
310-203-1000 john@ritterpharma.com
Ritter Pharmaceuticals (NASDAQ:RTTR)
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