Ritter Pharma Concludes Last Patient Visit of Its Phase 2b/3 Clinical Trial of RP-G28 for the Treatment of Lactose Intoleranc...
2016年10月17日 - 9:30PM
Marketwired
Ritter Pharmaceuticals Concludes Last Patient Visit of Its Phase
2b/3 Clinical Trial of RP-G28 for the Treatment of Lactose
Intolerance
LOS ANGELES, CA-(Marketwired - Oct 17, 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 the last
patient has completed dosing and all monitoring visits in its Phase
2b/3 clinical trial of RP-G28 for the treatment of lactose
intolerance. Topline results of the trial are expected to be
announced in the first quarter of 2017.
Andrew J. Ritter, Co-Founder and President of Ritter
Pharmaceuticals stated, "We are pleased to have met our timeline
and concluded the dosing of our investigational drug in 377
patients. This significant milestone brings us one step closer to
data read-out and reporting. Considering the enormous population of
over 40 million individuals in the United States that suffer from
lactose intolerance and the lack of sufficient treatment options,
we are eager to establish our therapeutic product as potentially
the first FDA-approved treatment for this condition."
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 RP-G28 in patients with
moderate to severe lactose intolerance symptoms. Enrollment was
initiated in March of 2016 and completed in August 2016, achieving
the company's projected enrollment time period. 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 underwent a
30-day treatment, followed by a 30-day post-treatment evaluation of
dairy tolerance [1]. 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.
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.
[1] Additional information on the study is available at:
https://clinicaltrials.gov/ct2/show/NCT02673749?term=lactose+intolerance&rank=6
Contact Information
Contacts Investor Contact: David Burke dburke@theruthgroup.com
(646) 536-7009 Media Contact: Chris Hippolyte
chippolyte@theruthgroup.com (646) 536-7023
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