Ritter Pharmaceuticals Announces Issuance of New Patents for its Lactose Intolerance Treatment, RP-G28, and Provides an Updat...
2017年5月3日 - 1:45AM
Ritter Pharmaceuticals, Inc. (NASDAQ:RTTR) (“Ritter
Pharmaceuticals” or the “Company”), a leading developer of novel
therapeutic products that modulate the human gut microbiome to
treat gastrointestinal diseases, today announced that it has been
issued three new patents directed to its development compound
RP-G28. The Company is also providing an update on its phase
3 program based on conversations with regulatory authorities and
experts.
The Company has been issued two new U.S. patents
and one new Australian patent. The two new U.S. patents (U.S.
Patent Nos. 9,579,340 and 9,592,248) are directed to compositions
containing RP-G28 and methods of using RP-G28, further
strengthening the intellectual property positions of RP-G28.
The issuance of an Australian patent (No. 20102184) provides
additional international protection for compositions containing the
compound.
“We are pleased to add these additional issued
patents to our portfolio of issued and pending claims, providing
both validation and protection for our compound, RP-G28, in
development for the treatment of lactose intolerance,” stated
Michael Step, CEO of Ritter Pharmaceuticals. “We now have 15
issued patents and over 25 additional pending patent
applications. This additional intellectual property continues
to protect our compound and its uses, likely beyond 2030.”
In addition to the new intellectual property, the
company has been working diligently on preparing for phase 3,
having had preliminary discussions with its regulatory experts and
the U.S. Food and Drug Administration (FDA). “We will be
holding an end of phase 2 meeting with the FDA to present and
discuss our phase 3 plan, for which we hope to receive guidance and
agreement on what is expected before filing a new drug application
(NDA) for commercializing RP-G28,” said Andrew Ritter, President
and co-founder of Ritter Pharmaceuticals. “We believe that
the completion of one well-powered phase 3 study with robust
clinical results may be sufficient to successfully file this
NDA. Based on our communication with the FDA, including our
Type C meeting in March 2017 and subsequent communications, we feel
we have established agreement with the FDA on defining clinically
meaningful benefit to patients and have established endpoints that
we feel are both achievable in the clinic and represent sufficient
basis for an approval once completed. We will be discussing
the final features of this trial and other relevant aspects of the
program with the FDA at our upcoming meeting to ensure we have a
product that meets regulatory goals in phase 3,” stated Andrew
Ritter.
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 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 that
the FDA will not agree with our interpretation of the data results
from our phase 2b/3 clinical trial and 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, 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.
Contacts
Ellen Mochizuki
310-203-1000
ellen@ritterpharma.com
Ritter Pharmaceuticals (NASDAQ:RTTR)
過去 株価チャート
から 6 2024 まで 7 2024
Ritter Pharmaceuticals (NASDAQ:RTTR)
過去 株価チャート
から 7 2023 まで 7 2024