US-based biotechnology company Cytonics has started a Phase I clinical trial of a new therapeutic for osteoarthritis of the knee.
The first-in-human study aims to evaluate CYT-108, a recombinant protein designed to inhibit proteases that degrade cartilage in arthritic joints.
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CYT-108 is a recombinant variant of the alpha-2-macroglobulin (A2M) blood serum protein and is designed to increase protease-inhibition activity.
The Phase I trial will involve a single intra-articular dose of CYT-108 being administered to patients at two intervals, 90 days apart.
Following treatment, patients will undergo regular monitoring to assess the drug’s safety, pharmacokinetics and potential to alleviate joint pain and stiffness while improving mobility.
CYT-108’s unique aspect is its dual approach to protease inhibition, which targets both specific and broad-spectrum proteases.
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By GlobalDataThe drug is based on Cytonics’ existing Autologous Protease Inhibitor Concentrate (APIC) system, a medical device that enriches A2M for injection into joints.
If approved, it could be the first and only disease-modifying therapy for osteoarthritis.
Cytonics president and CEO Joey Bose said: “Our first-in-human clinical trial is the culmination of six years of preclinical research and development, during which we overcame many technical challenges in developing our recombinant A2M variant, CYT-108.
“The preclinical data is compelling, demonstrating signs of CYT-108’s protective capabilities not only in the cartilage tissue but in multiple other joint physiologies that are involved in the pathogenesis of osteoarthritis.
“Furthermore, we believe that the development of CYT-108 is de-risked by the clinical and commercial success of our first-generation OA therapy, the APIC medical device, which has treated more than 8,000 patients using autologous A2M selectively concentrated from their own blood.”
Based in Florida, US, Cytonics aims to develop molecular diagnostics and therapeutics for chronic musculoskeletal diseases such as osteoarthritis.
The company has raised more than $25m in private funding and has received $1.8m in research grants from the US National Institutes of Health (NIH).
