Ritter Pharmaceuticals Completes Enrollment for Phase 2b/3 Trial of RP-G28 in Lactose Intolerance
2016年8月15日 - 9:30PM
Marketwired
Ritter Pharmaceuticals Completes Enrollment for Phase 2b/3 Trial
of RP-G28 in Lactose Intolerance
LOS ANGELES, CA-(Marketwired - Aug 15, 2016) - Ritter
Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or
the "Company"), a pharmaceutical company developing novel
therapeutic products that modulate the human gut microbiome to
treat gastrointestinal diseases, today announced that it has
completed patient enrollment on schedule for its Phase 2b/3
clinical trial of its investigational compound RP-G28 for the
treatment of lactose intolerance. Topline results of the trial are
expected to be announced in the first quarter of 2017.
The Phase 2b/3 trial is a double-blind, placebo-controlled,
three arm, multicenter study evaluating safety, efficacy and
tolerability of two dosing regimens of its investigational compound
RP-G28 in patients with moderate to severe lactose intolerance
symptoms. Enrollment was initiated in March of 2016 and completed
within 6-months, achieving the company's projected enrollment
milestones. The study aims to evaluate a patient's ability to
consume dairy foods post-treatment with improved tolerance and
reduced digestive symptoms. A total of 377 subjects were enrolled
in the trial with 18 clinical sites participating throughout the
United States. Patients undergo a 30-day treatment, followed by a
30-day post-treatment evaluation of dairy tolerance1. In addition,
the study will evaluate each participant's microbiome, expanding
knowledge of the effects that RP-G28 may have on adapting the gut
microbiota in a beneficial manner.
Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue
University and Chairman of Ritter Pharmaceuticals' medical advisory
board, further stated, "The rapid speed of recruitment and sheer
number of patients requesting participation in the trial
demonstrates that lactose intolerant individuals are actively
seeking options to treat embarrassing and often painful symptoms
associated with this condition.
William Sandborn, M.D., Chief and Professor, Division of
Gastroenterology and Director at UCSD Inflammatory Bowel Disease
Center, further added, "It is exciting to see rapid progress in a
large human clinical study involving the microbiome in a GI
condition. We feel the knowledge gained from exploring our study's
microbiome data could be beneficial in a number of diseases."
Andrew J. Ritter, Founder and President of Ritter
Pharmaceuticals, added, "We are delighted to have successfully met
our enrollment target on schedule. I would like to recognize our
clinical sites for their hard work and diligence in helping us
achieve our goals. Completion of enrollment marks an important
milestone in our pursuit of the first FDA-approved treatment for
lactose intolerance which may help the over 60 million Americans
and globally millions more who suffer from this condition."
1 Additional information on the study is available at:
https://clinicaltrials.gov/ct2/show/NCT02673749?term=lactose+intolerance&rank=6
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products
that modulate the human gut microbiome to treat gastrointestinal
diseases. The Company is advancing human gut health research by
exploring the metabolic capacity of gut microbiota, and translating
the functionality of these microbiome modulators into safe and
effective applications. Their lead drug candidate, RP-G28, has the
potential to become the first FDA-approved drug for lactose
intolerance, a condition that affects more than one billion people
worldwide.
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 release of topline results from
our Phase 2b/3 clinical trial of RP-G28. 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 outcomes 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, 2015 and Quarterly
Reports on Form 10-Q for the periods ended March 31, 2016 and June
30, 2016. 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 Information
ContactsInvestor Contact:David Burkedburke@theruthgroup.com(646)
536-7009Media Contact:Chris
Hippolytechippolyte@theruthgroup.com646.536.7023
Ritter Pharmaceuticals (NASDAQ:RTTR)
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