INTENT Biologics, a clinical-stage biotechnology company focused on developing exosome-based therapies for serious diseases with significant unmet medical needs, has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational therapy, PEP Biologic, for the treatment of Diabetic Foot Ulcers (DFU).

The designation, granted under Investigational New Drug (IND) application 019567, is intended to accelerate the development and regulatory review of therapies that demonstrate the potential to offer substantial improvements over existing treatment options for serious or life-threatening conditions.

The latest designation builds on the Fast Track status previously granted to PEP Biologic and further strengthens its regulatory pathway. According to the company, the recognition highlights the urgent need for improved therapies for chronic, non-healing diabetic foot ulcers and validates the regenerative potential of its platelet-derived exosome technology.

PEP Biologic is designed to deliver regenerative biological signals that regulate immune responses, reduce excessive inflammation and stimulate tissue repair and regeneration. The company believes the therapy could redefine the treatment approach for chronic wounds by addressing the underlying biological causes rather than providing passive wound coverage.

"Breakthrough Therapy designation is a transformational milestone for INTENT Biologics and for the field of advanced wound care," said Suneet Varma, Chief Executive Officer, INTENT Biologics. He noted that patients with diabetic foot ulcers continue to face high rates of non-healing wounds, infections, hospitalisations and amputations despite current treatment options, adding that the FDA's decision recognises the therapy's potential to significantly improve patient outcomes while enabling an expedited regulatory pathway.

Dr. Atta Behfar, Co-Founder of RION and Scientific Founder of the PEP platform, said PEP Biologic represents a first-in-class exosome therapy designed to activate the body's natural healing mechanisms. He added that the FDA designation validates both the science behind platelet-derived exosomes and their potential to transform treatment for chronic, difficult-to-heal wounds.

Diabetic foot ulcers remain one of the most serious complications associated with diabetes and are a leading cause of lower-limb amputations worldwide. Many patients fail to achieve sustained healing with currently available therapies, creating a need for treatments capable of overcoming chronic inflammation, impaired tissue repair and defective regenerative signalling.

PEP Biologic originated from the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Programme and has been developed using RION's platelet-derived exosome manufacturing platform. The therapy is formulated as a shelf-stable lyophilised powder containing regenerative exosomes that promote tissue regeneration and modulate immune responses. INTENT Biologics is advancing the therapy into pivotal clinical trials across multiple advanced wound care indications.