Ritter Pharmaceuticals Completes Dosing of Last Patient in Pivotal 557-Subject Phase 3 Clinical Trial of RP-G28 in Patients w...
07 May 2019 - 11:15PM
Top-line Data Readout on Target for early Q4
2019
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 final patient
in its first pivotal Phase 3 clinical trial of RP-G28 for the
potential treatment of Lactose intolerance (LI), a study known as
the “Liberatus” study (NCT03597516), has completed the 30-day
treatment dosing period.
“We are excited to announce that the last of the
557 enrolled patients in our Liberatus trial has completed dosing
and we remain on track for data readout in early Q4 2019,” said
Andrew J. Ritter, CEO of Ritter Pharmaceuticals. “With patient
completion of the 30-day treatment period, approximately 43%, or
240 patients are continuing at various points through the 90-day
“real-world” observational portion of the trial, while
approximately 50%, or 280 subjects have completed the trial. To
date, we project the rate of patients lost to follow-up or dropout
to be approximately or below 10% of the study population. No safety
signals have been reported to date which continues to support the
well-tolerated safety and tolerability profile we have observed in
earlier clinical studies.”
The Phase 3 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 underwent a 2-week screening
period, followed by a randomized 30-day study drug treatment period
(RP‑G28 or placebo) followed by 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. Aligning with FDA guidance, the primary endpoint in this
study compares RP-G28 to placebo on the reduction from baseline of
the lactose intolerance (LI) symptom composite score at Day 61
after 30 days of treatment and 30 days of real-world lactose
exposure. Secondary endpoints evaluate LI signs and symptom
outcomes to evaluate patients’ continued treatment benefit. The
study utilizes prior validated symptom assessment measures 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. The study remains blinded to all participants and
analysis of the data will not take place until all patients have
completed all protocol periods and the data base 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 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.
Forward-Looking StatementsThis
press release contains 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
completion of the Liberatus study, our release of data from the
study, expected trial results and the funding and timing of future
clinical studies. 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
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