Appili Therapeutics Aligns with FDA on ATI-1801 NDA Submission

Appili Therapeutics Inc., a biopharmaceutical company specializing in the development of treatments for infectious diseases and medical countermeasures, provided a significant update on October 31, 2024. The U.S. Food and Drug Administration (FDA) has given positive feedback on the development strategy for ATI-1801, a topical formulation of paromomycin designed to treat cutaneous leishmaniasis, a skin infection affecting many individuals worldwide.

Don Cilla, President and CEO of Appili Therapeutics, expressed that the FDA's positive response simplifies and reduces the risks of the development program for ATI-1801. This agreement on the development strategy allows Appili to utilize key results from the clinical dossier provided by the U.S. Army Medical Materiel Development Activity (USAMMDA). These results include successful outcomes from a Phase 3 study, paving a clearer path towards a New Drug Application (NDA) submission.

The FDA's agreement includes establishing a scientific link between previous clinical trial materials and new drug product batches through a validated in-vitro release test (IVRT) method and a new reference standard for IVRT studies. This approach should streamline the completion and submission of an NDA without needing additional clinical data.

Appili plans to implement this strategy and continue advancing the ATI-1801 program, subject to securing necessary funding. ATI-1801 has been granted Orphan Drug Designation by the FDA for certain cutaneous leishmaniasis forms. The company is also exploring the possibility of a priority review voucher (PRV) for ATI-1801. If granted, it would be Appili's second PRV-eligible program, alongside ATI-1701.

In another significant development, Appili announced an arrangement with Aditxt Inc. On April 2, 2024, both companies entered into a definitive agreement where Aditxt Inc., through its subsidiary Adivir, Inc., will acquire all issued and outstanding Class A common shares of Appili. Shareholders of Appili will receive cash and a fraction of Aditxt common stock as part of this transaction.

This transaction offers a premium to Appili's recent trading price, providing shareholders with immediate value upon completion. On October 1, 2024, Appili secured an interim order from the Ontario Superior Court of Justice, allowing for the distribution of all necessary meeting materials for a special shareholders meeting scheduled for November 6, 2024. Shareholders are urged to vote their shares promptly.

The special meeting of shareholders will be held virtually, with detailed instructions and information available on Appili's website and SEDAR+. The company emphasizes the importance of shareholders' participation in voting.

Appili’s ATI-1801, licensed from the U.S. Department of Defense through the U.S. Army Medical Materiel Development Activity, has shown safety and efficacy in multiple Phase 2 and Phase 3 studies. This topical product offers a potential solution for cutaneous leishmaniasis, which currently requires invasive treatments and hospitalization. ATI-1801 presents a less invasive, effective outpatient therapy option.

Appili Therapeutics aims to tackle life-threatening infections by developing a pipeline of novel therapies. The company's portfolio includes an FDA-approved ready-made suspension of metronidazole for antimicrobial infections, a vaccine candidate to eliminate a biological weapon threat, and a topical antiparasitic treatment for a disfiguring disease. Led by an experienced management team, Appili is committed to its mission of combating global infections.