RION Announces First Patient Dosed in Phase 2 Clinical Study of Purified Exosome Product™ for Diabetic Foot Ulcers

RION, a clinical-stage regenerative medicine company at the forefront of exosome therapeutics, announced today the first subject was dosed in the Phase 2 clinical trial with its novel product, known as Purified Exosome Product™ (PEP™). This event marks a pivotal milestone in evaluating PEP™ as an innovative treatment for chronic conditions such as Diabetic Foot Ulcers (DFUs).

PEP was administered to the first subject as part of a 40-subject Phase 2A study. The Phase 2A study is a multi-center, prospective, open-label, and randomized study to evaluate the safety and efficacy of topically applied PEP. The objective of the study is to compare subjects treated with PEP versus Standard of Care for up to 12 weekly applications (NCT06319287).

Annually, DFUs affect an estimated 18.6 million individuals globally, leading to significant morbidity and economic stress on healthcare systems, with treatment costs in the U.S. alone reaching approximately $13 billion. PEP™ features a polyvalent mode of action critical for tissue healing in patients suffering with DFUs.

“Dosing the first subject in the Phase 2 trial represents a key clinical advancement of our lead program and is an important moment for both the company and the field of exosome science,” said Dr. Atta Behfar, Co-founder of RION. “With the Phase 2 effort, Rion has established key advances in exosome manufacturing and scaling, while cementing its commitment to revolutionizing the treatment of chronic wounds. This pioneering exosome therapy is a testament to the potential of PEP™ to radically improve advanced wound care paradigms and patient outcomes.”

A positive Phase 2 trial outcome has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA) laying the foundation for PEP™ to address a significant unmet medical need in the realm of diabetic wound care.

Source – BusinessWire

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