Appili Therapeutics Announces New Late-Stage Clinical Program ATI-1801 to Treat Cutaneous Leishmaniasis
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
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
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
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
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.
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
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