Biopharmaceutical company Acurx Pharmaceuticals Inc (NASDAQ: ACXP) disclosed on Monday that it has received conditional FDA acceptance for CIFBEZY, the proposed proprietary name for its lead antibiotic candidate ibezapolstat, alongside a trademark allowance from the U.S. Patent and Trademark Office.
The milestones establish the proposed commercial identity for ibezapolstat as Acurx prepares to advance the treatment into its international Phase 3 programme for the acute treatment and reduction of recurrence of Clostridioides difficile infection. Final FDA review and approval of the brand name will be requested with the marketing application.
Acurx said ibezapolstat is Phase 3 ready, subject to financing, with the company targeting a single Phase 3 trial to support potential indications for both treatment and reduction of recurrence of Clostridioides difficile infection.
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