Inozyme Pharma Gets FDA Fast Track Designation for INZ-701 in ABCC6 Deficiency

By Chris Wack

Inozyme Pharma said the U.S. Food and Drug Administration granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency.

Fast Track is an FDA program designed to facilitate and expedite the development and review of new medicines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need.

The biopharmaceutical company said the designation for INZ-701 was been granted based on nonclinical pharmacology data and preliminary safety and efficacy data from its ongoing Phase 1/2 trial in adults with ABCC6 Deficiency.

With Fast Track designation, the company said the development of INZ-701 can benefit from more frequent engagement with the FDA and expedited regulatory review.

In April, Inozyme reported positive topline safety and immunogenicity data from its ongoing Phase 1/2 trial of INZ-701 in adults with ABCC6 Deficiency. Clinical improvements were observed in vascular pathology, visual function, and patient reported outcomes.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 02, 2024 08:55 ET (12:55 GMT)

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