Appili Therapeutics Announces Alignment with FDA on Development Requirements for ATI-1801 Topical Antiparasitic Product NDA Submission

Core Insights - Appili Therapeutics has received positive feedback from the FDA regarding the development strategy for ATI-1801, a topical formulation of paromomycin for treating cutaneous leishmaniasis, which is a significant step towards submitting a New Drug Application (NDA) [1][2][8] Development Strategy - The FDA's agreement on the proposed strategy allows Appili to utilize key results from previous clinical trials, including a successful Phase 3 study, to expedite the NDA submission process [2][3] - The strategy includes developing an in-vitro release test (IVRT) method and manufacturing a new reference standard to support the scientific bridge to prior studies, which will facilitate a quicker NDA submission [2] Product Information - ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis and is being evaluated for eligibility for a priority review voucher (PRV) [4] - The product has demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies, offering a non-invasive treatment option that can be administered in an outpatient setting [8] Transaction Details - Appili has entered into an arrangement agreement with Aditxt Inc. for the acquisition of all issued and outstanding Class A common shares of the Company, providing shareholders with immediate value [5][6] - Under the terms of the transaction, shareholders will receive US$ 0.0467 in cash and a fractional share of Aditxt common stock [5][6] Shareholder Engagement - Shareholders are encouraged to vote their shares ahead of the special meeting scheduled for November 6, 2024, to discuss the transaction [7]