Cutaneous Leishmaniasis Disease Program Advances

Appili Therapeutics Inc. recently announced a product update for the first quarter of its fiscal year 2025, which ended on June 30, 2024.

“In recent months, we’ve achieved significant milestones by engaging regulatory authorities for ATI-1701 and ATI-1801, and together with our partner, Saptalis Pharmaceuticals, we launched our leading asset, LIKMEZ™ (ATI-1501),” said Don Cilla, President and CEO of Appili, in a press release on August 13, 2024.

“These achievements, together with ATI-1701 U.S. Air Force Academy (USAFA) funding commitments, are expected to enable us to execute our infectious disease programs and advance their development to bring these products to market for the benefit of patients and shareholders.”

ATI-1701, a novel live-attenuated vaccine for preventing F. tularensis, has secured $14 million in awards from the USAFA.    Tularemia is a potentially serious illness caused by the bacterium Francisella tularensis. People can become infected in several ways, including tick and deer fly bites and contact with infected animals.

Under the USAFA Cooperative Agreement, Appili will manage a comprehensive development program, including nonclinical studies, CMC/manufacturing, clinical preparatory, and regulatory activities supporting an IND submission in 2025. Appili has engaged with the U.S. Food and Drug Administration (“FDA”) via a pre-IND meeting, confirming the development pathway for ATI-1701, and is incorporating suggested changes into the development plan.

ATI-1801, a novel topical formulation of paromomycin (15% w/w), is under advanced clinical development for treating cutaneous leishmaniasis, a Neglected Tropical Disease, is a disfiguring skin infection affecting hundreds of thousands globally. Cutaneous and mucosal leishmaniasis can cause substantial morbidity; visceral and mucosal leishmaniasis can be life-threatening.

Appili is currently engaging with the FDA. In 2024, it submitted a type-B meeting request to discuss linking previously generated Phase 3 data and agreeing on the necessary registration package for a New Drug Application submission. ATI-1801 has received an Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis. 

In September 2023, Appili and its U.S. partner, Saptalis Pharmaceuticals LLC., announced the approval by the U.S. FDA of LIKMEZ™ (ATI-1501), a proprietary taste-masked liquid suspension formulation of metronidazole. LIKMEZ is the first FDA-approved ready-made suspension of metronidazole, addressing the unmet need in both pediatric patients and patients with dysphagia. Saptalis launched LIKMEZ in November 2023, and the product is available to patients and doctors in the U.S.