Ritter Pharmaceuticals Provides Phase 3 Liberatus Clinical Trial and Regulatory Update
2019年6月20日 - 10:15PM
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 Food
and Drug Administration (FDA)-approved treatment for lactose
intolerance (LI), today provided an update of its Phase 3 clinical
trial and regulatory efforts.
- The 557-subject Phase 3 clinical
trial of RP-G28, known as “Liberatus”, remains on track with
anticipated top-line data readout in early Q4 2019. As previously
reported, all subjects have completed enrollment with
last-patient-last-visit expected in July 2019. The study remains
blinded and unblinding and analysis of the data will not take place
until patients have completed all protocol periods and the database
has been locked.
- The Company has been in dialog with
the FDA to confirm that the analyses defined in the Statistical
Analysis Plan (SAP) for the Liberatus Phase 3 clinical trial would
be supported by the FDA. The Company has achieved alignment over
key elements of the study’s SAP, including the primary endpoint,
secondary endpoints and other critical components.
“We are pleased with our most recent
interactions with the FDA, we understand their clinical and
regulatory priorities and expectations going into our upcoming data
readout,” said Andrew J. Ritter, CEO of Ritter Pharmaceuticals. “We
expect that the feedback and agreements reached with the FDA will
result in a high-quality analysis of the Liberatus data.”
About Phase 3 Liberatus Clinical
Trial The 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 LI. Participants underwent a 2-week screening
period, followed by a randomized 30-day study drug treatment period
(RP‑G28 or placebo), then 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 from baseline of the lactose intolerance
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 of 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 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
completion of the Liberatus clinical trial, our release of data
from the study, expected trial results, the funding and timing of
future clinical studies, interactions and comments related to the
FDA and our regulatory strategy and SAP. 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
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