FibroBiologics has completed site onboarding for its Phase 1/2 clinical trial evaluating CYWC628 in patients with refractory diabetic foot ulcers. The company stands ready to activate additional sites as needed to achieve recruitment targets outlined in the protocol.

The open-label, multicenter study will treat participants for up to 12 weeks, comparing standard-of-care alone to standard-of-care plus either a low or high dose of topically applied allogeneic fibroblast spheroid therapy CYWC628. Key objectives include assessing safety, tolerability and wound healing efficacy through clinical observations and imaging.

An interim analysis is scheduled after a predefined cohort completes six weeks of treatment to evaluate primary safety and efficacy endpoints. Southern Star Research is managing all trial operations across the Asia-Pacific region to ensure high-quality data generation.