Phase 2 Trial for Diabetic Foot Ulcers Begins with First Patient Dosed

RION, a company at the cutting edge of regenerative medicine and exosome therapies, has reached a significant milestone with the commencement of a Phase 2 clinical trial for its innovative product, the Purified Exosome Product™ (PEP™). The trial's first participant has received the treatment, which is being evaluated as a potential solution for chronic conditions like Diabetic Foot Ulcers (DFUs).

The Phase 2A study involves 40 participants and is designed to assess the safety and effectiveness of PEP when applied topically. It is a multi-center, open-label, and randomized trial that will compare the outcomes of those treated with PEP against the current Standard of Care, with treatments administered weekly for up to 12 weeks.

DFUs are a prevalent complication of diabetes, impacting around 18.6 million people worldwide each year. These ulcers not only cause significant suffering but also place a considerable economic burden on healthcare systems, with treatment costs in the United States estimated at approximately $13 billion. PEP™ is intended to support tissue healing with its multifaceted approach, which is crucial for patients dealing with DFUs.

Dr. Atta Behfar, RION's Co-founder, has highlighted the importance of this clinical advancement, stating that it represents a significant step forward for the company and the broader field of exosome science. RION's efforts in Phase 2 have focused on refining exosome manufacturing and scaling processes, with a commitment to transforming the treatment of chronic wounds. The success of PEP™ in the Phase 2 trial could lead to a pivotal study and the submission of a Biologics License Application (BLA), positioning PEP™ to address a substantial unmet need in diabetic wound care.

RION has its roots in Mayo Clinic and is renowned for its pioneering work in isolating and mass-producing platelet-derived regenerative exosomes into a shelf-stable form, known as PEP™. The company is at the forefront of regenerative medicine, with a proprietary biomanufacturing platform that aims to shape the future of regenerative therapy.

PEP™, derived from human platelets, is a lyophilized powder containing stabilized platelet-derived regenerative exosomes. It has been shown in extensive research to promote cell growth, new blood vessel formation, reduce inflammation, and protect cells. RION is currently exploring PEP™'s potential in preclinical and clinical studies for various indications, with a primary focus on wound healing. The company is also working on IND-enabling efforts for musculoskeletal, cardiovascular, pulmonary, and women's health disorders, aiming to provide new solutions where existing standards of care fall short.

DFUs are a severe complication characterized by slow-healing wounds on the feet that are prone to infection. They significantly affect the quality of life, causing pain, reduced mobility, and the risk of amputation. It is estimated that 15-25% of individuals with diabetes will develop a DFU during their lifetime, with a concerning rate of amputation in these cases. The management of DFUs is complex, with high recurrence rates and a high mortality rate associated with the condition. The economic impact of DFUs is also significant, with direct treatment costs and indirect costs related to productivity loss and disability.