RION Begins Dosing in Phase 2 Study of Purified Exosome Product™ for Diabetic Foot Ulcers

RION, a clinical-stage regenerative medicine company based in Rochester, Minnesota, has announced a significant milestone in its ongoing research into exosome therapeutics. The company has successfully initiated dosing in a Phase 2 clinical trial for its innovative treatment, Purified Exosome Product™ (PEP™), aimed at addressing chronic conditions like Diabetic Foot Ulcers (DFUs).

The Phase 2A clinical trial involves 40 participants and is designed to assess the safety and effectiveness of topically applied PEP. This multi-center, open-label, randomized study will compare the outcomes of subjects treated with PEP against those receiving the Standard of Care over a period of up to 12 weeks (NCT06319287).

DFUs are a severe complication of diabetes, impacting an estimated 18.6 million people worldwide each year. These ulcers not only contribute significantly to patient morbidity but also impose a substantial economic burden on healthcare systems, with annual treatment costs in the United States alone estimated at approximately $13 billion. PEP™ offers a unique polyvalent approach essential for tissue healing in patients suffering from DFUs.

Dr. Atta Behfar, Co-founder of RION, described the dosing of the first subject in the Phase 2 trial as a crucial advancement for the company and the broader field of exosome science. He highlighted that the Phase 2 trial underscores RION's progress in exosome manufacturing and its commitment to transforming chronic wound care. Dr. Behfar emphasized the potential of PEP™ to significantly enhance advanced wound care paradigms and improve patient outcomes.

Should the Phase 2 trial yield positive results, it could set the stage for a pivotal study and the eventual submission of a Biologics License Application (BLA). This progression would enable PEP™ to address a significant unmet medical need in diabetic wound care.

RION originated from the Mayo Clinic after two decades of extensive research and innovation. The company is recognized globally for its breakthroughs in isolating and mass-producing platelet-derived regenerative exosomes into shelf-stable products like PEP™. RION's advanced biomanufacturing platform is at the forefront of regenerative therapy, harnessing the therapeutic potential of these cellular messengers.

The Purified Exosome Product™ (PEP™) developed by RION is a shelf-stable, lyophilized powder derived from human platelets. This product contains stabilized, platelet-derived regenerative exosomes discovered by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program. PEP™ is designed to promote cell growth and the formation of new blood vessels, reduce inflammation, and protect cells. Extensive research by RION and its collaborators has shown PEP™'s potential to heal various damaged tissues. Currently, the company is evaluating PEP™ in multiple preclinical and clinical studies for different conditions, with a primary focus on wound healing. Additionally, RION is exploring applications for PEP™ in musculoskeletal, cardiovascular, and pulmonary diseases, as well as women’s health disorders, creating new solutions for unmet clinical needs.

Diabetic Foot Ulcers (DFUs) are a common and serious complication of diabetes, leading to wounds on the feet that are slow to heal and prone to infection. These ulcers significantly affect the quality of life, causing pain, reduced mobility, and an increased risk of amputation. Approximately 15-25% of individuals with diabetes will experience a DFU in their lifetime, and about 14-24% of these cases will result in amputation. In the United States, an amputation due to DFU occurs every three and a half minutes, underscoring the condition's severity. Managing DFUs is challenging, with many patients suffering recurrent ulcers and a high mortality rate, with around 40% of patients succumbing to the condition. The economic impact of DFUs is also considerable, with substantial direct treatment expenses and indirect costs related to loss of productivity and long-term disability.

As RION continues its clinical trials, the potential of PEP™ to transform the treatment landscape for DFUs and other chronic conditions remains a promising frontier in regenerative medicine.