Biopharma Bucking Market Trends on Positive FDA Feedback

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Thursday, October 31, 2024

This firm’s treatment for a disfiguring skin infection has demonstrated safety and efficacy across multiple Phase 2 and Phase 3 studies, and shares are holding their own despite today's downturn in the overall market.

Biopharmaceutical Appili Therapeutics Inc. (TSX: APLI) (OTCPink: APLIF) focuses on drug development for infectious diseases and medical countermeasures. In a press release today, the firm announced that the U.S. Food and Drug Administration (“FDA”) provided positive feedback regarding the development strategy for ATI-1801 and agreed on the necessary registration package to support a New Drug Application (“NDA”). 

The treatment, ATI-1801, is a novel topical formulation of paromomycin (15% w/w) and is under advanced clinical development for treating cutaneous leishmaniasis, a disfiguring skin infection affecting hundreds of thousands globally.

The FDA agreed with the company’s proposed strategy in a recent response to Appili's Type B meeting request. Appili’s proposed strategy establishes a scientific bridge between previous clinical trial material and new drug product batches. This approach includes developing an appropriately validated in-vitro release test (“IVRT”) method and manufacturing a new reference standard to use in IVRT studies to support the scientific bridge to products used in prior studies. This will allow the completion and submission of an NDA much sooner than if additional clinical data were required.

Appili is a target acquisition for Aditxt, a social innovation platform dedicated to accelerating promising health innovations. Shares of Aditxt (ADTX) were trading up in noon trade.

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