RION, a clinical-stage regenerative medicine company developing exosome-based therapeutics, has announced the enrolment of the first patient in its Phase 1b clinical study evaluating Purified Exosome Product (PEP) for the treatment of Knee Osteoarthritis (OA).
Discovered at the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Programme, PEP is an exosome therapeutic that designed to promote cell growth and formation of new blood vessels, while also reducing inflammation and protecting cells.
RION’s open-label, multi-centre trial will enrol 24 patients across the United States.
Participants with symptomatic unilateral Knee OA will receive single intra-articular injections of PEP in escalating doses to evaluate safety, tolerability, and preliminary efficacy, including signals of cartilage regeneration and inflammation reduction.
Atta Behfar, MD, PhD is co-founder of RION.
Behfar said: “The enrolment of the first patient in this trial represents an exciting milestone for RION and the field of regenerative medicine.
“PEP offers a groundbreaking approach to addressing the unmet needs of knee osteoarthritis patients by leveraging the body’s natural repair mechanisms.
“This trial is the first step in advancing PEP as a transformative therapy that goes beyond symptom management to target the underlying causes of this debilitating condition.”
Knee Osteoarthritis is the most common form of arthritis, affecting approximately 364 million people worldwide each year.
Symptomatic Knee OA is highly prevalent, with 40 per cent of men and 47 per cent of women developing the condition during their lifetimes.
An estimated 5.4 million people in the UK have OA.
But despite its prevalence, current treatment options primarily manage symptoms rather than addressing the underlying biology of the disease, leaving a critical need for novel therapies that can restore joint function.
The disease often leads to significant pain and disability, highlighting the urgent need for therapies that address both symptoms and the underlying drivers of joint degeneration.
