Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission
31 Octobre 2024 - 12:15PM
Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company”
or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases and medical countermeasures,
today announced that the U.S. Food and Drug Administration (“FDA”)
has provided positive feedback regarding the development strategy
for ATI-1801, and agreed on the necessary registration package to
support a New Drug Application (“NDA”). ATI-1801, a novel topical
formulation of paromomycin (15% w/w), is under advanced clinical
development for treating cutaneous leishmaniasis, a disfiguring
skin infection affecting hundreds of thousands globally.
“This positive response from the FDA simplifies
and de-risks our development program for ATI-1801,” said Don Cilla,
President and CEO of Appili Therapeutics. “The agency's agreement
with our proposed strategy enables Appili to leverage key results
from the clinical dossier for ATI-1801 licensed from U.S. Army
Medical Materiel Development Activity (“USAMMDA”), including the
successful results of a Phase 3 study, and provides a clear path
towards an NDA submission.”
In a recent response to Appili's Type B meeting
request, the FDA agreed with the Company's proposed strategy to
establish a scientific bridge between previous clinical trial
material and new drug product batches. This approach includes
developing an appropriately validated in-vitro release test
(“IVRT”) method and manufacturing a new reference standard to use
in IVRT studies to support the scientific bridge to products used
in prior studies. This will allow completion and submission of an
NDA much sooner than if additional clinical data were required.
Subject to securing the requisite funding Appili
expects to implement the agreed-upon strategy and continue to
advance ATI-1801 topical paromomycin cream (15% w/w) program to NDA
submission.
ATI-1801 has received Orphan Drug Designation
from the FDA for certain forms of cutaneous leishmaniasis. The
company is evaluating ATI-1801’s eligibility for a priority review
voucher (“PRV”), which, if confirmed, would make it the second
PRV-eligible program at Appili, alongside ATI-1701, which is
potentially eligible for a PRV pending renewal of certain U.S.
legislation.
Aditxt Arrangement
On April 2, 2024, the Company announced that it
had entered into a definitive arrangement agreement (the
“Arrangement Agreement”) pursuant to which Aditxt Inc. (NASDAQ:
ADTX) (“Aditxt”), through its wholly-owned subsidiary, Adivir,
Inc., agreed to acquire all of the issued and outstanding Class A
common shares of the Company. Under the terms of the Arrangement
Agreement, shareholders of the Company will receive (i) US$ 0.0467
in cash and (ii) 0.0000686251 of a share of Adixt common stock (the
“Transaction”).
This Transaction represents a premium to
Appili’s recent trading price, and assuming the completion of the
transaction, provides shareholders with immediate value.
On October 1, 2024, the Company obtained an
interim order from the Ontario Superior Court of Justice in
connection with the Transaction. The order permits the mailing of
all requisite meeting materials in connection with the special
meeting of Appili shareholders (the “Meeting”) scheduled to be held
virtually on November 6, 2024 at 11:00 am ET.
Shareholders are encouraged to vote
their shares as soon as possible.
The notice of the special meeting of
shareholders and management information circular containing all
relevant details with respect to the Meeting (including voting
instructions) and the Transaction are available on the Company’s
website at: www.appilitherapeutics.com/proxy-info/ as well as
under Appili’s profile on SEDAR+ www.sedarplus.ca.
About ATI-1801Licensed from the
U.S. Department of Defense through the U.S. Army Medical Materiel
Development Activity, Appili’s ATI-1801 is a novel topical product
with demonstrated safety and efficacy across multiple Phase 2 and
Phase 3 studies. As current treatments are often invasive and
require hospitalization, ATI-1801 has the potential to
significantly reduce suffering from cutaneous leishmaniasis by
providing patients in need with a safe and effective topical
therapy that can be used in the outpatient setting.
About Appili TherapeuticsAppili
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
an FDA approved ready-made suspension of metronidazole for the
treatment of antimicrobial infections, a vaccine candidate to
eliminate a serious biological weapon threat, and a topical
antiparasitic for the treatment of a disfiguring disease. Led by a
proven management team, Appili is at the epicenter of the global
fight against infection. For more information,
visit www.AppiliTherapeutics.com.
Forward Looking StatementsThis
news release contains “forward-looking statements”, including with
respect to (i) the potential for ATI-1801 as a treatment for
leishmaniasis and the proposed development plan for
ATI-1801(including the NDA submission and the expected timing
thereof) and (ii) the potential that certain of Appili’s programs
may be PRV-eligible. 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. These forward-looking statements reflect the current
expectations of the Company’s management for future growth, results
of operations, performance and business prospects and opportunities
and involve significant known and unknown risks, uncertainties and
assumptions, including, without limitation, those listed in the
annual information form of the Company dated June 25, 2024, and the
other filings made by the Company with the Canadian securities
regulatory authorities (which may be viewed
at www.sedarplus.ca). 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.
Media Contact:Jenna McNeil,
Corporate Affairs and Communications ManagerAppili TherapeuticsE:
JMcNeil@AppiliTherapeutics.com
Investor Relations Contact:Don
Cilla, Pharm.D. M.B.A.Appili
TherapeuticsE: Info@AppiliTherapeutics.com
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