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 globally¹, leading to significant morbidity and economic stress on healthcare systems, with treatment costs in the U.S. alone reaching approximately $13 billion². 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.

About RION

RION was born out of Mayo Clinic after two decades of research and innovation. RION is located in Rochester, MN and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf stable PEP™.

RION is rewriting the regenerative medicine playbook. Our cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers. RION’s regenerative PEP™ technology will be integral to the therapeutic exosome revolution.

About PEP™

RION's Purified Exosome Product™ (PEP™) is a shelf stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. Discovered by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, PEP™ is an exosome therapeutic that is designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells. RION and its scientific collaborators have performed extensive research showing the potential of PEP™ to heal a wide array of damaged tissue. The company is currently evaluating PEP™ in preclinical and clinical studies for several indications. While our focus remains on wound healing, multiple IND-enabling efforts in musculoskeletal, cardiovascular disease, pulmonary disease and women’s health disorders are creating new solutions where current standards of care cannot address unmet clinical needs.

About Diabetic Foot Ulcers (DFU)

Diabetic Foot Ulcers (DFUs) are a severe and common complication of diabetes, characterized by wounds on the feet that are slow to heal and susceptible to infection. DFUs significantly impact the quality of life due to pain, reduced mobility, and the potential for amputation. Approximately 15-25% of people with diabetes will develop a DFU in their lifetime³. Alarmingly, around 14-24% of these cases result in amputation⁴. Furthermore, every three and a half minutes in the US⁵, there is an amputation due to DFU, highlighting the severity of this condition. The management of DFUs is challenging, with many patients experiencing recurrent ulcers. Additionally, DFU patients face a high mortality rate, with about 40% succumbing to the condition⁶. The economic burden of DFUs is substantial, imposing significant costs on healthcare systems, from direct treatment expenses to indirect costs related to loss of productivity and long-term disability.

References

1. Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID: 37395769; PMCID: PMC10723802.
2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882.
3. Yazdanpanah L, Shahbazian H, Nazari I, Arti HR, Ahmadi F, Mohammadianinejad SE, Cheraghian B, Hesam S. Incidence and Risk Factors of Diabetic Foot Ulcer: A Population-Based Diabetic Foot Cohort (ADFC Study)-Two-Year Follow-Up Study. Int J Endocrinol. 2018 Mar 15;2018:7631659. doi: 10.1155/2018/7631659. PMID: 29736169; PMCID: PMC5875034.
4. Liao X, Li SH, El Akkawi MM, Fu XB, Liu HW, Huang YS. Surgical amputation for patients with diabetic foot ulcers: A Chinese expert panel consensus treatment guide. Front Surg. 2022 Nov 8;9:1003339. doi: 10.3389/fsurg.2022.1003339. PMID: 36425891; PMCID: PMC9679004.
5. Amputation Prevention Alliance. (n.d.). Amputation prevention alliance. Amputation Prevention Alliance | ADA.
6. Jeyaraman K, Berhane T, Hamilton M, Chandra AP, Falhammar H. Mortality in patients with diabetic foot ulcer: a retrospective study of 513 cases from a single Centre in the Northern Territory of Australia. BMC Endocr Disord. 2019 Jan 3;19(1):1. doi: 10.1186/s12902-018-0327-2. PMID: 30606164; PMCID: PMC6318899.

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