INTENT Biologics Receives FDA Fast Track Designation for First-in-Class Exosome Therapy for Diabetic Foot Ulcers
Key Insights
INTENT Biologics (search) has received FDA Fast Track designation for PEP Biologic (search)™, a first-in-class exosome-based therapy for treating diabetic foot ulcers (search) under IND 019567.
If approved, PEP Biologic (search) would be the first FDA-approved biologic for diabetic foot ulcers (search) in nearly 30 years and the first exosome-based biologic ever approved.
The therapy is advancing into pivotal Phase III clinical development in 2026 after completing Phase II trials, targeting a condition affecting 19-34% of diabetes (search) patients.
INTENT Biologics (search), a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration has granted Fast Track designation for PEP Biologic (search)™ for the treatment of diabetic foot ulcers (search) under IND 019567. The designation represents a significant regulatory milestone for what could become the first FDA-approved biologic for diabetic foot ulcers in nearly three decades and the first exosome-based biologic ever approved.
Addressing Critical Unmet Medical Need
Diabetic foot ulcers (search) affect an estimated 19-34% of patients with diabetes (search) during their lifetime and represent a leading cause of lower-extremity amputations and a major driver of healthcare costs. Many patients fail to achieve durable healing with currently available treatment options, resulting in increased mortality rates.
"FAST TRACK designation from FDA is a meaningful milestone confirming our belief that patients suffering serious burns, ulcers and other complicated wounds continue to suffer from high unmet medical need that current therapies do not adequately address," said Suneet Varma, Chief Executive Officer of INTENT Biologics (search).
Novel Exosome-Based Mechanism
PEP Biologic (search) is a platelet-derived exosome biologic designed to deliver regenerative signaling messages that modulate immune responses and promote tissue repair, supporting resolution of inflammation and tissue regeneration. The therapy is packaged as a shelf-stable lyophilized powder, with each dose containing regenerative exosomes that deliver polyvalent biologic signals to induce tissue regeneration and regulate immune responses for accelerated healing.
The treatment features a novel mechanism of action that reduces hyper-inflammation, regulates immune response, and repairs and regenerates tissue. INTENT Biologics (search) is advancing PEP Biologic (search) based on a proprietary exosome platform originating from RION (search) and Mayo Clinic research.
Clinical Development Timeline
The company has completed Phase II trials and is advancing PEP Biologic (search) into pivotal Phase III clinical development in 2026. Under the Fast Track program, PEP Biologic is now eligible for more frequent interactions with the FDA, rolling submission of portions of its Biologics License Application (BLA), and potentially accelerated or priority review in the future.
"We are more excited than ever as we have completed our Phase II trial and advanced PEP Biologic (search) into pivotal Phase III clinical development in 2026 and prepare for registration and commercialization in the near future," Varma stated.
Scientific Foundation
PEP Biologic (search) (Purified Exosome Product) is a first-in-class exosome therapeutic discovered through Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program and developed on RION (search)'s industry-leading platelet-derived exosome biomanufacturing platform. The development builds on more than two decades of research at Mayo Clinic.
FDA Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and address unmet medical needs, including the potential to dramatically improve patient outcomes compared to existing therapies.