RION Announces Initiation of Phase 2A Clinical Study for Purified Exosome Product™ (PEP™) in Diabetic Foot Ulcers

  • RION’s Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU).
  • Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems.
  • The trial is a key part of RION’s broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

RION, located in Rochester, MN, is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived exosomes. 

RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU).

Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year and are associated with increasing rates of amputation and death​​. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems. The trial is a key part of RION’s broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.

Building on the success of the Phase 1B study conducted at Mayo Clinic, RION’s Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes.

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

Dr. Atta Behfar, Co-founder of RION, said, “The progress we’ve made in advancing PEP™, reflects our deep commitment to developing powerful exosome therapies that unleash the body’s ability to heal from within. Not only will this study address a critical unmet need in chronic wound care, but it’s a pivotal moment for RION. We are disrupting the boundaries of exosome technology, to develop a new generation of therapies endowed with the potential to truly transform the way we treat complex and incurable diseases.”

In the United States, the treatment of DFUs remains a significant challenge in the medical community, with no new biologics approved by the US FDA for diabetic wounds since the late 1990s. RION is committed to bringing exosome-based therapies to patients as quickly and safely as possible to transform the management and outcomes of this devastating condition​​​​.

SourceBusinessWire

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