Breakthrough Designation represents a major regulatory milestone on the path to a Biologics License Application (BLA) for a first-in-class platelet-derived exosome biologic being advanced into pivotal clinical development for advanced wound care
ROCHESTER, Minn.--(BUSINESS WIRE)--INTENT Biologics, a clinical-stage biotechnology company developing first-in-class exosome-based biologic therapies for serious conditions with significant unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PEP Biologic™ for the treatment of diabetic foot ulcers (DFU) under IND 019567.
FDA Breakthrough Therapy designation is intended to expedite the development and review of truly innovative new therapeutic drugs and biologics intended to treat serious or life-threatening conditions where clinical evidence indicates the therapy may demonstrate substantial improvement over available treatments on one or more clinically significant endpoints.
This represents another significant regulatory milestone for INTENT Biologics and further strengthens the development pathway for PEP Biologic building on PEP Biologic on previously granted Fast Track from FDA, reflecting the serious unmet need in DFU and the therapeutic potential for PEP Biologic’s novel regenerative mechanism of action to address the underlying biology of chronic, non-healing wounds, burns and 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 a platelet-derived exosome biologic designed to deliver regenerative signaling messages that modulate immune responses, reduce hyper-inflammation and promote tissue repair and regeneration. INTENT believes this mechanism has the potential to redefine the standard of care treatments by moving beyond passive coverage and 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 among the most serious and costly complications of diabetes and are a leading cause of lower-extremity amputations. Many patients fail to achieve durable healing with currently available treatment options, creating a significant need for therapies that can address persistent inflammation, impaired tissue repair and failed regenerative signaling.
About PEP Biologic™
PEP Biologic (Purified Exosome Product) is a first-in-class exosome therapeutic discovered through Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program and developed on RION’s industry-leading platelet-derived exosome biomanufacturing platform. Packaged as a shelf-stable lyophilized powder, each dose contains regenerative exosomes that deliver polyvalent biologic signals to induce tissue regeneration and regulate immune responses for accelerated healing. With a novel mechanism of action that reduces hyper-inflammation, regulates immune response and repairs & regenerates tissue, PEP Biologic is being advanced by INTENT Biologics into pivotal clinical trials for a range of advanced wound care indications where current treatments fail to address the underlying biology.
About INTENT Biologics
INTENT Biologics is a clinical-stage biotechnology company dedicated to developing first-in-class exosome-based therapeutics in Advanced Wound Care. Spun out of RION, a global leader in regenerative exosome science, and built on more than two decades of research at the Mayo Clinic, INTENT is advancing PEP Biologic into late-stage clinical development for multiple indications in advanced tissue regeneration. Headquartered in Minnesota, the company is focused on “revolutionizing and replacing” standards of care in chronic wounds by harnessing regenerative exosomes to treat diseases with significant unmet need. More information can be found at www.intent.bio.
About RION
RION is a clinical-stage regenerative medicine company founded out of the Mayo Clinic after two decades of stem cell and exosome research and innovation. RION is the global leader in isolating and mass-producing platelet-derived regenerative exosomes into a proprietary therapeutic platform to produce Purified Exosome Product (PEP), a shelf-stable biologic designed to activate the body’s natural healing processes. RION is advancing a deep pipeline with clinical and preclinical programs in diabetic foot ulcers, knee osteoarthritis, musculoskeletal injury, dermatologic conditions, pulmonary disease, cardiovascular health, and women’s health. RION’s regenerative PEP technology will be integral to the therapeutic exosome revolution. More information can be found at www.riontx.com.
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