Ritter Pharmaceuticals Initiates First Pivotal Phase 3 Trial for RP-G28 for the Treatment of Lactose Intolerance
June 27 2018 - 7:00AM
Conference Call
Today - June 27, 2018 at 4:30 p.m. ET
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 the first patient has been enrolled in the first
pivotal Phase 3 clinical trial of RP-G28.
“The initiation of this Phase 3 clinical trial for RP-G28,
called the “Liberatus” study, is an important milestone not only
for the company, but potentially for the way lactose intolerance is
treated,” said Andrew J. Ritter, co-founder and president of Ritter
Pharmaceuticals, Inc. “To date, there are no prescription drugs
available to treat this condition, and we believe that our approach
of modulating the microbiome in the gut may have a tremendous
impact on the day-to-day lives of millions who suffer from lactose
intolerance. We look forward to providing further information and
updates on the trial as they become available.”
Liberatus Study Design Description: The purpose
of this study is to determine the efficacy, safety and tolerability
of RP-G28 to treat LI when compared to placebo. The study is a
multicenter, randomized, double-blind, placebo-controlled,
parallel-group study conducted in the United States. The estimated
enrollment of the trial will be 525 participants conducted at
approximately 28 sites. The protocol design includes a 2-week
screening period that includes one week of study drug
administration, 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. There will be
a second randomized, 30-day, study drug treatment period to assess
safety and efficacy of a repeat round of therapy. The primary
endpoint of the study will be the mean change in LI symptom
composite score 30-days post-treatment compared to baseline.
Secondary endpoints will evaluate LI signs and symptoms and global
assessment outcomes to evaluate patients’ continued treatment
benefit. The study will utilize the prior validated symptom
assessment measure and patient questionnaires to capture relevant
outcomes. In addition, risk-based data review will be used to
monitor and assess potential protocol deviations and site quality
indicators.
“The Liberatus protocol includes a number of study design
improvements and additional site and data safeguards incorporating
learnings from previous clinical studies of RP-G28,” said Diane J.
Plotkin, vice president of clinical development at the Company.
“These modifications aim to help ensure the consistent performance,
quality, and integrity of data collected by the multiple sites
participating in the study in order to best capture the efficacy
and meaningfulness of treatment benefit compared to placebo.”
Conference CallRitter Pharmaceuticals will host
a conference call, after market close, today at 4:30p.m. ET (1:30
p.m. PT). The conference call can be accessed by dialing
1-877-270-2148 for domestic callers and 1-412-902-6510 for
international callers and requesting the “Ritter Pharmaceuticals
Phase 3 Trial Initiation” conference call. The conference
call will also be available via webcast in the Investor section of
the Company’s website under “Events and Presentations”
(http://www.ritterpharmaceuticals.com/investors/events-presentations)
and an archive of the teleconference will be available on the
website for 90 days following the call.
About Ritter PharmaceuticalsRitter
Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma)
develops novel 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 of people worldwide. RP-G28 has been studied in
Phase 2 trials, and is now in Phase 3 clinical development. 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, including statements regarding the management
transition and the timing and commencement of our first Phase 3
clinical trial. Any statements contained herein that do not
describe historical facts are forward-looking statements that 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. 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. These forward-looking statements are made only
as of the date hereof, and the Company undertakes no obligation to
update or revise the forward-looking statements, except as
otherwise required by law, whether as a result of new information,
future events or otherwise.
Contacts
Investor Contact:
John Beck
310-203-1000
john@ritterpharma.com
Media Contact:
Jules Abraham
CoreIR
917-885-7378
julesa@coreir.com
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