Appili Therapeutics (TSX:APLI; OTCPink:APLIF) announced that the FDA has provided positive feedback on the development strategy and NDA application for the company’s ATI-1801 for cutaneous leishmaniasis (CL).
ATI-1801, a novel topical formulation of paromomycin, is in advanced clinical development for treating CL, a disfiguring skin infection affecting hundreds of thousands worldwide.
“This positive response from the FDA simplifies and de-risks our development program for ATI-1801,” said Don Cilla, president and CEO of Appili.
“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, including the successful results of a Phase 3 study, and provides a clear path towards an NDA submission,” he added.
