RION, a clinical-stage regenerative medicine company at the forefront of exosome-based therapeutics, today announced the enrollment of the first patient in its Phase 1b clinical study evaluating Purified Exosome Product™ (PEP™) for the treatment of Knee Osteoarthritis (OA). This milestone highlights RION’s commitment to advancing innovative regenerative therapies that address unmet medical needs
Knee Osteoarthritis is the most common form of arthritis, affecting approximately 364 million people worldwide each year (1). In the United States alone, Knee OA is associated with more than one million hospitalizations annually, primarily for total joint replacement, contributing to healthcare costs ranging from $5.7 billion to $15 billion (2). 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.
Phase 1b Study Overview
RION’s Phase 1b study represents a major step forward in developing regenerative therapies for Knee OA. This open-label, multi-center trial will enroll 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.
“The enrollment of the first patient in this trial represents an exciting milestone for RION and the field of regenerative medicine,” said Atta Behfar, MD, PhD, co-founder of RION. “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.”
Source – BusinessWire
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