FibroBiologics Achieves First Patient Dosing in CYWC628 Phase 1/2 Trial for Diabetic Foot Ulcers

Three consecutive GMP manufacturing runs running in parallel with first-in-human dosing signals that FibroBiologics is treating batch release logistics and clinical execution as a single, integrated challenge, a posture that will define the reproducibility record regulators examine as CYWC628 advances. The company confirmed that initial patient dosing in its Phase 1/2 trial for refractory diabetic foot ulcers (DFUs) occurred during the week of 1 June 2026.

Drug product from the second GMP run has been released and was scheduled for shipment to Australia during the week of 15 June 2026. Manufacturing of the first two batches of a third GMP run is already complete. For ATMP programmes operating under comparability and process validation expectations, the ability to demonstrate inter-run consistency at this stage carries direct weight in future regulatory submissions.

The trial is a prospective, multicenter, randomised study evaluating the safety, tolerability, and efficacy of CYWC628, an investigational topically administered allogeneic fibroblast cell-based therapy, across up to 12 weeks of treatment. Cohorts are randomised to standard of care alone or standard of care plus a low or high dose of CYWC628. The multi-site, cross-border design introduces the batch release and cold-chain documentation burden that QA leads at ATMP sponsors will recognise: each shipment to Australia requires release against GMP standards on both ends of the supply chain.

Chief Scientific Officer Hamid Khoja, Ph.D., characterised the consecutive runs as evidence that the fibroblast manufacturing platform is reproducible and capable of supplying ongoing and future clinical demand. For manufacturing and quality teams, reproducibility at this scale is not a marketing claim, it is the dataset that underpins process validation packages and, eventually, comparability arguments if the process is transferred or scaled.

The trial's progression to active dosing means batch disposition timelines, chain-of-custody documentation, and site readiness at Australian clinical centres are now live operational variables, not planning assumptions.

The third GMP run's completion will be a measurable indicator of whether inter-batch consistency holds as the programme scales to meet enrolment demand across multiple sites.

Source: FibroBiologics, Inc. via GlobeNewswire, 16 June 2026.