Rochester, Minn. — INTENT Biologics announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to PEP Biologic™ for the treatment of diabetic foot ulcers.
The designation applies to the company’s first-in-class platelet-derived exosome biologic under IND 019567 and represents a major regulatory milestone as INTENT prepares the treatment for pivotal Phase 3 clinical development and a potential Biologics License Application.
FDA Breakthrough Therapy designation is intended to accelerate the development and review of drugs and biologics for serious or life-threatening conditions when preliminary clinical evidence indicates they may offer substantial improvement over existing treatments.
The designation builds on the Fast Track status previously granted to PEP Biologic and reflects the significant unmet need among patients with diabetic foot ulcers.
“Breakthrough Therapy designation is a transformational milestone for INTENT Biologics and for the field of advanced wound care,” said Suneet Varma, Chief Executive Officer of INTENT Biologics. “Patients suffering from diabetic foot ulcers continue to face high rates of non-healing, infection, hospitalization and amputation despite the current standard of care. FDA’s decision recognizes the potential of PEP Biologic to meaningfully improve outcomes for these patients and provides an expedited regulatory path as we advance into pivotal clinical development.”
PEP Biologic is designed to deliver regenerative signaling messages that regulate immune responses, reduce excessive inflammation and promote tissue repair and regeneration. INTENT said the treatment could move advanced wound care beyond passive wound coverage toward active biologic regeneration.
“PEP Biologic is not another skin substitute or incremental wound care product,” said Dr. Atta Behfar, co-founder of RION and scientific founder of the PEP platform. “It is a first-in-class exosome therapeutic engineered to switch on the body’s own healing program. Exosomes are poised to reshape modern medicine, and this Breakthrough Therapy designation is an example of what our technology can do for diseases with few options and poor prognosis. It affirms both the science behind regenerative platelet-derived exosomes and PEP Biologic’s potential to change the course of serious, non-healing wounds.”
Diabetic foot ulcers are a serious complication of diabetes and a leading cause of lower-extremity amputations. Many patients do not achieve lasting healing with existing treatments, creating demand for therapies that address persistent inflammation, impaired tissue repair and failed regenerative signaling.
