Cytonics Corporation has announced the completion of enrollment in its Phase 1 clinical trial evaluating CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor, for the treatment of osteoarthritis (OA) of the knee. This first-in-human trial is designed to assess the safety and efficacy of CYT-108 as a potential disease-modifying therapy.
The multi-center, 6-month, double-blind, randomized controlled trial (RCT) enrolled 22 patients with unilateral, mild-to-moderate, primary OA of the knee. Participants were randomized 1:1 to receive either CYT-108 or a placebo. The primary endpoint focuses on the tolerability of CYT-108 when delivered via intra-articular injection. Secondary endpoints will evaluate improvements in self-reported pain and mobility. An exploratory endpoint will measure peptide fragments in blood serum as a biomarker for cartilage degradation.
Joey Bose, President & CEO of Cytonics Corp, stated, "We are thrilled to have completed enrollment of all 22 patients across our three clinical sites in Australia, beating our recruitment forecast by more than a month. This will expedite the Phase 1 clinical study report and our IND filing with the FDA in 2025, bringing us one step closer to developing the first and only disease-modifying therapy for osteoarthritis."
About CYT-108
CYT-108 is engineered to inhibit specific proteases involved in the molecular pathogenesis of osteoarthritis. It combines highly specific and broad-spectrum protease inhibition activity, distinguishing it from small molecule inhibitors that target single proteases. The development of CYT-108 is based on the success of Cytonics' Autologous Protease Inhibitor Concentrate (APIC) system, a 510(k) medical device that enriches autologous A2M for intra-articular injection. The clinical and commercial success of APIC, cleared by the FDA in 2015, supports the potential of CYT-108, as it demonstrates that high concentrations of A2M can be introduced into arthritic joints without significant side effects.
Osteoarthritis Context
Osteoarthritis is a prevalent and debilitating joint disease affecting millions worldwide. Current treatments primarily focus on managing symptoms such as pain and inflammation, with limited options available to modify the disease's progression. The potential of CYT-108 to act as a disease-modifying agent could address a significant unmet need in the treatment of osteoarthritis.
To date, no drug-related adverse events have been reported, and CYT-108 appears well-tolerated in all patients. Top-line results from the Phase 1 study are expected in the second quarter of 2025.
