Appili Therapeutics Advances ATI-1801 Development for Cutaneous Leishmaniasis with FDA Alignment
Key Insights
Appili Therapeutics (search) has secured FDA alignment on development requirements for ATI-1801, a novel topical paromomycin formulation for treating cutaneous leishmaniasis (search), paving the way for NDA submission.
The company's LIKMEZ™, the first FDA-approved liquid metronidazole formulation, has launched in the U.S. market through partner Saptalis Pharmaceuticals (search), offering a new option for patients with swallowing difficulties.
Shareholders have approved a pending acquisition by Aditxt Inc. (search), with the transaction expected to close in Q1 2025, subject to financing conditions.
Appili Therapeutics (search) has achieved significant progress in its infectious disease portfolio, marking key regulatory and commercial milestones across multiple programs. The company's development strategy continues to focus on addressing urgent unmet needs in infectious disease treatment.
FDA Alignment Accelerates ATI-1801 Development
In a significant regulatory advancement, Appili has secured FDA alignment on the development requirements for ATI-1801, their novel topical antiparasitic treatment for cutaneous leishmaniasis (search). The 15% w/w paromomycin formulation targets a disfiguring skin infection that affects hundreds of thousands globally each year.
The FDA has endorsed Appili's proposed strategy to establish a scientific bridge between previous clinical trial materials and new drug product batches. This agreement enables the company to leverage existing clinical data, including successful Phase 3 study outcomes, streamlining the path toward a New Drug Application (NDA).
ATI-1801 has received Orphan Drug Designation from the FDA for specific forms of cutaneous leishmaniasis (search), potentially qualifying for a priority review voucher (PRV).
LIKMEZ™ Launches in U.S. Market
Appili's commercialization efforts have reached a milestone with the U.S. launch of LIKMEZ™ (ATI-1501), the first and only FDA-approved liquid formulation of metronidazole. The product addresses a significant market need by providing an alternative for patients who struggle with the traditional tablet form's bitter taste and swallowing difficulties.
Through its partnership with Saptalis Pharmaceuticals (search), Appili stands to benefit from sales-based milestone payments and royalties. The product's patent protection extends through 2039, securing a long-term commercial opportunity. Saptalis is currently seeking an alternative commercialization partner to maximize market reach.
Corporate Development and Financial Position
Shareholders have overwhelmingly approved a proposed acquisition by Aditxt Inc. (search) (NASDAQ:ADTX) through its subsidiary Adivir, Inc. The transaction, subject to Aditxt securing sufficient financing, is expected to close in the first quarter of 2025.
Financial results for the third quarter ended December 31, 2024, showed a net loss of $0.5 million ($0.00 per share), compared to a $0.1 million loss in the same period of 2023. The company maintained a cash position of $0.2 million as of December 31, 2024.
Dr. Don Cilla, President and CEO of Appili, expressed optimism about the company's trajectory: "It is a tremendous privilege to lead the company towards new stages of growth, and I'm excited to steer Appili towards new milestones. This year holds significant importance, marked by advancing funded ATI-1701 activities to IND submission and engaging regulatory authorities to align on ATI-1801 development plans."