Cytonics Corporation has announced the successful completion of the Phase 1 clinical trial for CYT-108, an investigational therapy for osteoarthritis. The trial, involving the first nine patients, demonstrated a favorable safety profile with no drug-related adverse events reported through six months of monitoring. This milestone marks a significant step forward in the development of a potential disease-modifying treatment for osteoarthritis, a condition affecting millions worldwide.
The multi-center, randomized, double-blind Phase 1 study evaluated the safety, pharmacokinetics, and exploratory efficacy of CYT-108 in patients with primary osteoarthritis of the knee. Patients received two intra-articular doses of CYT-108, administered on Day 0 and Day 90, with follow-up assessments conducted through Day 180. In addition to safety, the study is investigating biomarkers associated with cartilage degradation, as well as improvements in pain and joint function to inform the design of subsequent clinical trials.
CYT-108: A Novel Approach to Osteoarthritis Treatment
CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The protein's "bait" region, a substrate for proteases, has been engineered to increase its affinity for specific proteases known to play a significant role in the molecular pathogenesis of osteoarthritis. This targeted approach, combining highly specific and broad-spectrum protease inhibition, differentiates CYT-108 from small molecule inhibitors that target single proteases.
Joey Bose, President & CEO of Cytonics, stated, "The successful completion of the first cohort in our Phase 1 trial marks a significant milestone for CYT-108 and its potential to transform the treatment landscape for osteoarthritis. The absence of adverse events through six months of monitoring is an encouraging testament to the drug’s safety and tolerability."
The development of CYT-108 builds upon the success of Cytonics' first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system. APIC, a 510(k) medical device, selectively enriches autologous A2M for intra-articular injection into joints affected by osteoarthritis. The clinical and commercial success of APIC, cleared by the FDA in 2015, has de-risked the development of CYT-108 by demonstrating that high concentrations of A2M can be safely introduced into arthritic joints.
The Need for Disease-Modifying Osteoarthritis Therapies
Osteoarthritis is a prevalent and debilitating condition characterized by the breakdown of cartilage in joints, leading to pain, stiffness, and reduced mobility. Current treatments primarily focus on managing symptoms, with limited options available to address the underlying disease process. CYT-108 represents a promising approach to potentially modify the course of osteoarthritis by inhibiting the proteases involved in cartilage degradation.
If approved, CYT-108 may be the first and only disease-modifying therapy for osteoarthritis, addressing a significant unmet medical need.
