Ritter Pharmaceuticals Reports Top-Line Results from its Liberatus Phase 3 Trial of RP-G28 for Lactose Intolerance
September 12 2019 - 04:15PM
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, announced today that its Phase 3
clinical trial of RP-G28 for lactose intolerance (LI) failed to
demonstrate statistical significance in its pre-specified primary
endpoint.
Top-line data from the 557-subject Phase 3
clinical trial indicates that RP-G28 provided significant symptom
improvement in patients; however, there was no or little difference
compared to placebo. In the primary endpoint, measuring LI symptom1
reduction at day 61 (30 days post-treatment) compared to baseline,
the treatment group reported a 3.159 mean reduction compared to a
reported 3.420 mean reduction in the placebo group (p-value,
one-sided = 0.106). Additionally, RP-G28 missed its first secondary
endpoint of responders with a meaningful treatment benefit: 36.2%
of treatment group compared to 34.1% of placebo group (p-value,
one-sided= 0.284). The remaining secondary endpoints also missed
statistical significance differences with treatment and placebo
generally reporting similar results to each other. RP-G28 was
generally well-tolerated, with placebo and treatment groups
reporting similar safety profiles.
The Phase 3 multicenter, randomized,
double-blind, placebo-controlled, clinical trial enrolled 557
subjects with LI and was designed to determine the efficacy, safety
and tolerability of RP-G28 for LI. Participants underwent a 2-week
screening period, followed by a randomized 30-day study drug
treatment period, 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.
“We are deeply disappointed in the results of
the phase 3 clinical trial,” said Andrew J. Ritter, CEO at Ritter
Pharmaceuticals. “We believe the clinical trial was well-designed
and executed. We are continuing to analyze the results of the trial
to better understand the data and clinical outcomes to assess a
path forward, which may include alternative strategic options for
the Company.”
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 is also 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.
1 LI symptoms are comprised of a composite score
of abdominal pain, cramping, bloating and gas.
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
clinical trial results and the future plans of the Company.
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
Ritter Pharmaceuticals (NASDAQ:RTTR)
Historical Stock Chart
From Feb 2024 to Mar 2024
Ritter Pharmaceuticals (NASDAQ:RTTR)
Historical Stock Chart
From Mar 2023 to Mar 2024