07:57 AM EDT, 10/31/2024 (MT Newswires) -- Appili Therapeutics ( APLIF ) on Thursday said the U.S. Food and Drug Administration (FDA) has provided positive feedback regarding the development strategy for ATI-1801, a topical antibiotic treatment for cutaneous leishmaniasis, a disfiguring skin infection.

The regulator also agreed on the necessary registration package to support a New Drug Application (NDA). ATI-1801 has received Orphan Drug Designation from the FDA for certain forms of cutaneous leishmaniasis.

"This positive response from the FDA simplifies and de-risks our development program for ATI-1801," said Appili Chief Executive Don Cilla. "The agency's agreement with our proposed strategy enables Appili to leverage key results from the clinical dossier for ATI-1801 licensed from U.S. Army Medical Materiel Development Activity (USAMMDA), including the successful results of a Phase 3 study, and provides a clear path towards an NDA submission."

Appili also provided an update on its acquisition by Adivir, saying they company will be mailing meeting materials to shareholders ahead of the special meeting to be held on Nov. 6.