Ritter Pharmaceuticals Selects Medpace as its Clinical Research Organization for Pivotal Phase 3 Clinical Trial of RP-G28 in ...
2018年5月3日 - 7:00PM
Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a developer of novel
therapeutic products that modulate the gut microbiome to treat
gastrointestinal diseases with an initial focus on the development
of the first FDA-approved treatment for lactose intolerance, today
announces that it has signed an agreement with the clinical
research organization (CRO) Medpace to conduct the first of two
pivotal Phase 3 clinical trials for RP-G28 in patients with lactose
intolerance (LI).
“Our team has worked diligently to identify and
select the right CRO partner to execute our pivotal Phase 3
clinical trial for RP-G28,” said Andrew J. Ritter, co-founder and
president of Ritter Pharmaceuticals, Inc. “Medpace is an
established, highly regarded full-service Phase I-IV CRO with
expertise in numerous therapeutic areas that is focused on
supporting the biotech and pharmaceutical industry. It is a
scientifically-driven organization with a dedicated in-house study
team and clinical research physician support. Medpace has an
extensive portfolio of successfully completed late-stage clinical
programs supporting NDA filings, including programs with
patient-reported outcomes like ours. Medpace is our ideal CRO
choice as they provide the experience and range of services to
competently execute our Phase 3 study. With our CRO partner
secured, we remain on track to initiate our RP-G28 Phase 3 trial
this quarter.”
With support from Medpace, Ritter
Pharmaceuticals will conduct a multicenter, randomized,
double-blind, placebo-controlled, parallel-group trial in the
United States, in approximately 525 patients to evaluate the
efficacy, safety, durability, and tolerability of RP-G28 in
patients with lactose intolerance (LI). The primary objective of
the study is to assess the efficacy of RP-G28 compared to placebo
on the reduction from baseline of LI symptoms following 30 days of
treatment and 30 days of real-world lactose consumption. Secondary
objectives include assessments of the safety and tolerability of
treatment with RP-G28; the durability of effect of treatment on LI
symptoms after 3 months of lactose consumption; and the response
over time on patient-reported outcomes and global assessment
measures.
"Medpace is pleased to have been chosen by
Ritter Pharmaceuticals to conduct its Phase 3 study for RP-G28,"
said Susan Burwig, executive vice president, Operations at Medpace.
"Our team has the appropriate therapeutic experience in conducting
clinical trials in the area of gastrointestinal diseases. We look
forward to partnering with Ritter Pharmaceuticals and utilizing our
knowledge and experience in the GI and microbiome fields to execute
this pivotal trial."
About Ritter
Pharmaceuticals
Ritter 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 expected to
commence Phase 3 clinical development in the second quarter of
2018. 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.
About Medpace Inc.
Medpace is a scientifically driven, global,
full-service clinical contract research organization (CRO)
providing Phase I-IV clinical development services to the
biotechnology, pharmaceutical and medical device industries.
Medpace’s mission is to accelerate the global development of safe
and effective medical therapeutics through its high-science and
disciplined operating approach that leverages local regulatory and
deep therapeutic expertise across all major areas including
oncology, cardiology, metabolic disease, endocrinology, central
nervous system and anti-viral and anti-infective. Headquartered in
Cincinnati, Ohio, Medpace employs approximately 2,500 people across
36 countries. For more information visit the Medpace website
at: www.medpace.com.
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
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:
Shaun Novin
310-203-1000
shaun@ritterpharma.com
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