Topical formulation of paromomycin ATI-1801
already shown to be safe and effective against the disfiguring
disease in Phase 3 study
ATI-1801 may be eligible for tropical disease
priority review voucher if approved by FDA
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, today announced the addition
of ATI-1801, a clinical stage topical paromomycin product to treat
cutaneous leishmaniasis, to its development pipeline. Licensed from
the US Department of Defense (“DOD”) via the US Army Medical
Materiel Development Activity (“USAMMDA”), ATI-1801 is a novel
topical product with demonstrated safety and efficacy in a Phase 3
study. Appili will be working with international partners to
complete the remaining development activities to enable
registration with global regulatory authorities, including the US
Food and Drug Administration (“FDA”).
Cutaneous leishmaniasis is a disfiguring infection of the skin
that affects hundreds of thousands of people around the world
annually, characterized by the formation of lesions and ulcers that
often lead to scarring, disfigurement, disability, and
stigmatization of the infected. The disease is a serious impediment
to socioeconomic development, especially for women, and a priority
for governments and non-governmental organizations ("NGOs") around
the world. Current treatments are often invasive, toxic and/or
require hospitalization, limiting access.
ATI-1801 has the potential to significantly reduce the burden of
the disease by providing patients with a safe and effective topical
therapy that can be used in the outpatient setting. Appili holds
the full clinical dossier for ATI-1801, including the results of a
randomized, double-blind, vehicle-controlled Phase 3 study which
evaluated the safety and efficacy of ATI-1801 for the treatment of
cutaneous leishmaniasis in Tunisia. The study met its primary
endpoint, with ATI-1801 administered topically once daily for 20
days demonstrating a significant improvement in the rate of
clinical cure of the index lesion compared to vehicle (82% vs 58%;
p-value < 0.001).
Appili plans to meet with the FDA later this year to discuss the
previously generated Phase 3 data and agree on the necessary
registration package to support a new drug application (“NDA”)
submission, which the Company expects will include available
nonclinical, manufacturing, and clinical data generated to date.
Appili expects to pursue non-dilutive funding and partnership
opportunities with NGOs and government agencies which share the
Company’s focus on tropical diseases to help complete remaining
development work.
“We are excited to be working with our partners at the US DOD to
complete the development of and ultimately make available a product
urgently needed to address the disability and inequity caused by
cutaneous leishmaniasis,” said Dr. Armand Balboni, CEO of Appili
Therapeutics. “This is a unique opportunity to build on an
extensive data set and bring a treatment that has already
demonstrated Phase 3 efficacy to patients around the world. This is
exactly the type of mission that Appili was built to take on and I
look forward to applying our expertise, capabilities, and partner
network to this effort.”
Appili believes that ATI-1801 may be eligible for a priority
review voucher (“PRV”), if approved by the FDA. The PRV program was
developed to incentivize drug development in US government priority
areas including medical countermeasures and tropical diseases such
as leishmaniasis. Once issued, a PRV can be used by its holder to
accelerate the review of a subsequent drug submission. PRVs are
transferrable and the secondary market for PRVs is well established
with over 20 transactions reported publicly and recent transactions
often exceeding US$100 million. The Company is actively evaluating
the eligibility of ATI-1801 for a PRV which, if confirmed, would
make ATI-1801 the third PRV eligible program at Appili, joining
ATI-1701, a leading and potential first-in-class vaccine to prevent
infection by top priority biothreat Francisella tularensis, and
ATI-2307, Appili’s novel clinical stage antifungal candidate.
About ATI-1801
Appili’s ATI-1801 is a novel topical paromomycin product already
evaluated in Phase 3 study for the treatment of cutaneous
leishmaniasis, a disfiguring infection of the skin that affects
hundreds of thousands of people around the world annually and is
characterized by the formation of lesions and ulcers that often
lead to scarring, disfigurement, and stigmatization for those
infected. The disease is a serious impediment to socioeconomic
development, especially for women, and a priority for governments
and non-governmental organizations around the world. Appili intends
to work with these various stakeholders to help complete remaining
development activities, secure regulatory approvals, and ultimately
make the product available worldwide.
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 broad-spectrum antifungal, a vaccine candidate to
eliminate a serious biological weapon threat, and two novel
antibiotic programs. 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 statements
This news release contains “forward-looking statements”,
including with respect to the proposed development plans with
respect to ATI-1801, the potential for ATI-1801 to treat cutaneous
leishmaniasis, expected non-dilutive funding and partnership
opportunities and the potential PRV eligibility of ATI-1801.
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. 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 ATI-1801 may prove to be ineffective for
the treatment of cutaneous leishmaniasis, the risk that the Company
may never secure all requisite regulatory to develop and
commercialize ATI-1801, the risk that ATI-1801 may ultimately be
determined not to be PRV eligible, and the other risk factors
listed in the annual information form of the Company dated June 23,
2021, 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/20220412006175/en/
Media Contact: Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com
Investor Relations Contact: Stéphane Paquette; Vice
President, Corporate Development Appili Therapeutics E:
Info@AppiliTherapeutics.com
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