Ritter Pharmaceuticals Reaches Halfway Mark for Enrollment in Pivotal Phase 3 Clinical Trial of RP-G28 in Patients with Lacto...
December 04 2018 - 8:30AM
Full Enrollment on Target for Q2 2019 with Data
Readout Expected in the Second Half of 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), today
announced that it has passed the 50 percent enrollment point in its
first pivotal Phase 3 clinical trial of RP-G28 for the potential
treatment of LI, a study known as the “Liberatus” study.
“We are pleased to have achieved this important
milestone in study enrollment and we remain on track with our
projected timeline for the completion of the Liberatus study in the
second half of 2019,” said Andrew J. Ritter, CEO of Ritter
Pharmaceuticals. “RP-G28 has the potential to be the only
FDA-approved, pharmaceutical solution to treat lactose intolerance,
a condition afflicting more than 40 million people in the United
States and millions more worldwide. We look forward to sharing the
Liberatus study results with patients, medical professionals and
our investors next year.”
To date, 267 of the expected 525 study subjects
have been enrolled in the Liberatus study, with 79 percent (23 out
of 29) of the active screening clinical sites having enrolled at
least one study subject. For high-enrolling sites, total patient
enrollment is capped to ensure reasonable distribution among sites.
The demographic profile of the study subjects enrolled thus far in
the study is trending consistent with the Phase 2 program’s study
population, which was completed in 2017. Full enrollment is
expected to be achieved during the second quarter of 2019, with
data readout during the second half of 2019. Persons interested in
participating in the Liberatus study may receive more information
by visiting www.clinicaltrials.gov (NCT03597516) or visit
www.liberatusstudy.com/clinical-research.
The 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
symptoms and global assessment 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
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.
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
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