Ritter Pharmaceuticals Announces Phase 3 Plans after its End of Phase 2 Meeting with FDA on RP-G28 for Lactose Intolerance
18 August 2017 - 11:30PM
Marketwired
Ritter Pharmaceuticals Announces Phase 3 Plans after its End of
Phase 2 Meeting with FDA on RP-G28 for Lactose Intolerance
Company has incorporated guidance from FDA on key elements of
its Phase 3 program to support a New Drug Application (NDA) for
RP-G28
LOS ANGELES, CA-(Marketwired - Aug 18, 2017) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company"), a developer
of novel therapeutic products that modulate the human gut
microbiome to treat gastrointestinal diseases, today announced its
Phase 3 plans following its End-of-Phase 2 meeting with the U.S.
Food and Drug Administration (FDA) regarding the path forward for
RP-G28 for the treatment of lactose intolerance (LI).
The Company has incorporated guidance from the FDA on key
elements of its Phase 3 program and received clear guidance and
expectations on necessary components, including clinical,
non-clinical, and chemistry, manufacturing and controls (CMC)
requirements needed to support a successful NDA submission.
William Sandborn, M.D., Chief, Division of Gastroenterology at
University of California San Diego commented, "The FDA meeting was
very collaborative and constructive in helping the Company fully
understand the agency's objectives and expectations of the Phase 3
program. Having guidance and agreement on key clinical items such
as screening methods to ensure an appropriate patient population,
validated measures to capture appropriate clinical outcomes and
well-defined endpoints for assessment, I believe the Company is
well-positioned to enter Phase 3 trials to meet the FDA's guidance
on the expected clinical aspects needed for a successful NDA
filing."
Meeting highlights include:
- The Phase 3 clinical program: Will consist of two confirmatory
clinical trials of similar trial design and size as the Company's
Phase 2b/3 clinical trial and will include additional components to
allow for claims for durability of effect. The trials may be run in
parallel. The Company anticipates initiating the Phase 3 program
during the first half of 2018.
- Protocol design: Will consist of multi-center, randomized,
doubled-blind, placebo-controlled, parallel-group trials designed
to determine the efficacy, safety and durability of RP-G28 compared
to a placebo in subjects with lactose intolerance. The protocol
designs include screening to determine lactose intolerance, 30-day
course of treatment, and 6-months of post-treatment
observation.
- Primary endpoint: Will evaluate a patient's composite LI
symptoms (including abdominal pain, cramping, bloating and gas)
after a lactose challenge, comparing baseline symptom scores to
30-days post-treatment symptom scores to assess patients'
clinically meaningful benefit.
- Secondary endpoints: Will evaluate LI signs and symptoms and
global assessment outcomes to evaluate and assess a patient's
continued meaningful treatment benefit.
"We are pleased with the productive discussion and open dialog
we had with the FDA regarding our Phase 3 plans," said Andrew J.
Ritter, co-founder and president of Ritter Pharmaceuticals, Inc.
"We are confident we can execute a successful Phase 3 program
furthering our goal to ultimately file a successful NDA and
commercialize RP-G28 as the first FDA-approved treatment for
lactose intolerance."
RP-G28 is a novel, non-digestible oligosaccharide of ultra-high
purity developed to modulate the gut microbiome by stimulating and
adapting the bacteria in the gastrointestinal tract to metabolize
lactose to improve lactose tolerance. One 30-day course treatment
is expected to allow for durable treatment benefit.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com,
@RitterPharma) develops novel therapeutic products that modulate
the gut microbiome to treat gastrointestinal diseases. Its lead
product, RP-G28, has the potential to become the first FDA-approved
treatment for lactose intolerance, a condition that affects
millions worldwide. The Company is further exploring the
functionality and discovering the therapeutic potential gut
microbiome changes may have on treating/preventing a variety of
conditions including: gastrointestinal diseases, immuno-oncology,
metabolic, and liver disease.
Forward-Looking Statements
This release may contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements related to our proposed timing for initiating
our Phase 3 program and our ability to successfully complete a
confirmatory Phase 3 program that will be adequate to support a NDA
submission and to bring RP-G28 to market. Management believes that
these forward-looking statements are reasonable as and when made.
However, such statements involve a number of known and unknown
risks and uncertainties that could cause the Company's future
results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by
such forward-looking statements. These risks and uncertainties
include, but are not limited to, risks associated with the drug
development process generally, including the success, cost and
timing of planned clinical trials and the regulatory review
process. For a discussion of certain risks and uncertainties
affecting Ritter Pharmaceuticals' forward-looking statements,
please review the Company's reports filed with the Securities and
Exchange Commission, including, but not limited to, its Annual
Report on Form 10-K for the period ended December 31, 2016 and
Quarterly Reports on Form 10-Q for the periods ended March 31, 2017
and June 30, 2017. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date on which they are made. These statements are based on
management's current expectations and Ritter Pharmaceuticals does
not undertake any responsibility to revise or update any
forward-looking statements contained herein, except as expressly
required by law.
Contact Ellen Mochizuki 310-203-1000 ellen@ritterpharma.com
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