FDA grants Intent Bio BTD for PEP biologic in diabetic foot ulcers

Minnesota-based INTENT Biologics announced receipt of US FDA Breakthrough Therapy Designation (BTD) for PEP Biologic (Purified Exosome Product), a platelet-derived exosome biologic, for the treatment of diabetic foot ulcers (DFU) currently under Investigational New Drug (IND) application. The designation positions the company to pursue more intensive FDA engagement and rolling Biologics License Application (BLA) submission as it advances toward a pivotal trial.

The BTD is the second expedited designation the FDA has granted for PEP Biologic in DFU. INTENT received Fast Track Designation for the same indication in January 2026, and separately secured FDA agreement on a full pediatric waiver under its Initial Pediatric Study Plan the same month, removing the requirement to conduct pediatric studies as a condition of BLA submission. BTD provides intensive FDA guidance on an efficient development program, organizational commitment from senior FDA managers, and eligibility for rolling review and priority review, all of which can materially compress the timeline between pivotal data readout and regulatory decision.

PEP Biologic is a shelf-stable, lyophilized powder derived from human platelets. Each dose delivers regenerative exosomes — nanoscale extracellular vesicles — that carry polyvalent biologic signals designed to modulate immune responses, suppress chronic hyper-inflammation, and promote tissue repair and regeneration. The mechanism is distinct from passive coverage approaches such as skin substitutes: rather than providing a structural scaffold, PEP Biologic is intended to actively reactivate the body’s own healing program at the cellular signaling level, including through polarization of resident macrophages and modulation of T-cell activity.

INTENT is a clinical-stage biotech spun out of RION, a Rochester, Minnesota-based regenerative medicine company that has spent more than two decades developing platelet-derived exosome platforms originating from Mayo Clinic research. INTENT launched in September 2025 with exclusive, perpetual worldwide rights to RION’s PEP platform in inflammation and immunology, and has since accumulated a series of regulatory interactions with the FDA that collectively define a clear pre-BLA pathway.

DFU are among the most clinically and economically consequential complications of diabetes. The condition affects an estimated 19–34% of patients with diabetes during their lifetime and is a leading driver of lower-extremity amputation. Despite the severity of the disease, no new biologic has received FDA approval for diabetic wound care in approximately three decades. The most recent approved biologic in this space, becaplermin (a recombinant platelet-derived growth factor), received approval in 1997. The absence of approved regenerative biologics for DFU has left clinicians reliant on standard wound care, debridement, offloading, and infection management — approaches that fail to address the underlying biology of persistent inflammation and impaired tissue regeneration that characterises chronic, non-healing ulcers.

RION, INTENT’s parent, completed enrollment of a 59-patient, multi-center, prospective, open-label Phase II study in DFU in January 2025. That trial evaluated PEP applied topically in conjunction with standard wound care versus standard care alone, over up to 12 weekly applications, with primary endpoints of wound closure rates, time to healing, and safety. Topline results from this study have not been publicly disclosed, though the company has indicated the Phase II program is complete and that PEP Biologic is advancing into Phase III pivotal development in 2026.

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