Ritter Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Clinical Trial of RP-G28 in Patients with Lactose Intolerance
March 05 2019 - 8:30AM
Top-line Data Readout Expected in 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 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), a condition
afflicting more than 40 million people in the United States and
millions more worldwide, today announced that it has completed,
ahead of schedule, enrollment in its first pivotal Phase 3 clinical
trial of RP-G28 for the potential treatment of LI, a study known as
the “Liberatus” study (NCT03597516).
“We are encouraged and pleased to have achieved
this important milestone ahead of schedule. The large number of
patients interested in participating in the trial, highlights the
clinical need for new treatment options in this patient
population,” said Andrew J. Ritter, CEO of Ritter Pharmaceuticals.
“We remain on track for the top-line data readout of the Liberatus
study in early Q4 2019. As we near data readout and continue to
build our commercialization strategy for RP-G28, we look forward to
advancing our ongoing discussions with potential partners for the
continued further development and potential launch of this exciting
product candidate.”
Trial enrollment has exceeded expectations,
concluding with approximately 555 subjects randomized. No single
site enrolled more than 10% of the total population, 43% of sites
enrolled at least 15 subjects and more than 30 U.S. sites
participated in the study. Demographics, even though blinded,
indicate a broad population distribution with gender balance and
ethnic diversity. No safety signals have been reported to date
which continues to confirm the well-tolerated safety and
tolerability profile seen in earlier clinical studies.
“I have participated in hundreds of clinical
studies and was pleased to be part of the Liberatus trial to
evaluate RP-G28 in this under-served patient population,” said Mark
E. Kutner, M.D., the Medical Director at Suncoast Research Group.
“Patients were keen to participate and as such, recruitment went
well. Further, based on the profile of the treatment, patients were
motivated to participate, resulting in strong retention and overall
good compliance.”
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 undergo a 2-week screening period,
followed by a randomized 30-day study drug treatment period and 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 is the
mean change in LI symptom composite score 30-days post-treatment
compared to baseline. Secondary endpoints evaluate LI signs and
symptom outcomes to evaluate patients’ continued treatment benefit.
The study utilizes the prior validated symptom assessment measure
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.
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 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 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 completion of the Liberatus study, our
release of data from the study 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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