Appili Therapeutics Announces Notice of Allowance from the U.S. Patent and Trademark Office for ATI-1501 Liquid Oral Reformulation of Metronidazole
January 13 2023 - 7:19AM
Business Wire
Anticipated new patent strengthens ATI-1501’s potential position
as a more convenient alternative treatment option for metronidazole
prescriptions on the market.
Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company”
or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases and biodefense products, today
announced that the United States Patent and Trademark Office
(“USPTO”) has issued a Notice of Allowance of new patent claims for
ATI-1501, Appili’s liquid oral reformulation of the antibiotic
metronidazole. A notice of allowance is issued by the USPTO to
indicate that the application has passed the examination.
Metronidazole is a widely used frontline oral treatment with
over 10 million prescriptions written in the United States every
year to help treat parasitic and anaerobic bacterial infections.
The current tablet form of metronidazole is the only approved oral
form on the U.S. market, but its bitter taste and lack of
appropriate dosage forms for patients with difficulty swallowing
often presents treatment compliance challenges.
“We are pleased with this notice of allowance for a new patent
that will further strengthen ATI-1501’s potential as a more
convenient antibiotic treatment option,” said Don Cilla, Pharm.D.,
M.B.A., President and Chief Executive Officer of Appili
Therapeutics. “For far too long, the bitter taste of the current
form of metronidazole has made it challenging for patients to take,
increasing rates of treatment failure, infection recurrence and
antibiotic resistance. This patent protects our investment in
making metronidazole more accessible and easier to take for all
patients, especially for the elderly and children who often have
difficulty taking solid oral medicines.”
Appili and their partner Saptalis Pharmaceuticals LLC
(“Saptalis”), a New York-based specialty pharmaceuticals company,
expect ATI-1501 to be approved by the FDA by the end of 2023.
About Appili Therapeutics Appili Therapeutics is an
infectious disease biopharmaceutical company that is purposefully
built, portfolio-driven, and people-focused to fulfill its mission
of solving life-threatening infections. By systematically
identifying urgent infections with unmet needs, Appili’s goal is to
strategically develop a pipeline of novel therapies to prevent
deaths and improve lives. The Company is currently advancing a
diverse range of anti-infectives, including a vaccine candidate to
eliminate a serious biological weapon threat, a topical
antiparasitic for the treatment of a disfiguring disease, and a
novel easy to use, liquid oral formulation targeting parasitic and
anaerobic infections. Led by a proven management team, Appili is at
the epicenter of the global fight against infection. For more
information, visit www.AppiliTherapeutics.com.
About Saptalis Pharmaceuticals, LLC Saptalis
Pharmaceuticals, LLC is a rapidly growing pharmaceutical company
specialized in development, manufacturing, and commercialization of
generic and innovative products in liquid and semi-solid dosage
forms. Located in the Hauppauge Industrial Park on Long Island, NY,
USA, Saptalis has fully equipped Research & Development
Laboratories and state of the art commercial scale manufacturing
facility designed to meet FDA cGMP requirements. For more
information, visit www.Saptalis.com.
Forward looking statements This news release contains
“forward-looking statements”, including with respect to the
proposed development and commercialization plans for ATI-1501.
Wherever possible, words such as “may,” “would,” “could,” “should,”
“will,” “anticipate,” “believe,” “plan,” “expect,” “intend,”
“estimate,” “potential for” and similar expressions have been used
to identify these forward-looking statements. Forward looking
statements contained in this press release are provided in reliance
on certain assumptions, including with respect to the FDA
application and approval process for ATI-1501. Although the Company
believes that the expectations reflected in these forward-looking
statements are reasonable, the Company cannot give assurance that
these expectations will prove to have been correct.
Forward looking statements involve significant known and unknown
risks, uncertainties and assumptions, including, without
limitation, the risk that the New Drug Application for ATI-1501 may
ultimately not be approved by the FDA, and the other risk factors
listed in the annual information form of the Company dated June 23,
2022 and the other filings made by the Company with the Canadian
securities regulatory authorities (which may be viewed at
www.sedar.com). Should one or more of these risks or uncertainties
materialize or should assumptions underlying the forward-looking
statements prove incorrect, actual results, performance or
achievements may vary materially from those expressed or implied by
the forward-looking statements contained in this news release.
These factors should be considered carefully, and prospective
investors should not place undue reliance on the forward-looking
statements. The Company disclaims any intention or obligation to
revise forward-looking statements whether as a result of new
information, future developments or otherwise, except as required
by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230112005901/en/
Media: Celia Dewyer/APCO
Worldwide T: 1-646-717-9915 E: CDewyer@apcoworldwide.com
Investor Relations: Jenna
McNeil, Communications Manager Appili Therapeutics E:
Info@AppiliTherapeutics.com
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