Cytonics has announced the conclusion of subject enrolment in a Phase I clinical trial of CYT-108, for use as putative disease-modifying therapy for osteoarthritis (OA) of the knee.
CYT-108 is a recombinant variant of the alpha-2-macroglobulin blood serum protease inhibitor.
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The company commenced the Phase I clinical trial of a CYT-108 for osteoarthritis of the knee in July this year.
This first-in-human, multicentre, six-month, double-blind RCT trial is designed to assess the safety and efficacy of CYT-108 in patients with unilateral, mild-to-moderate, primary OA of the knee.
The tolerability of CYT-108 when administered through intra-articular injection to the joints will be the trial’s primary safety endpoint.
Secondary efficacy endpoints will measure improvements in self-reported pain and mobility in the treated joint.
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By GlobalDataAdditionally, an exploratory endpoint will analyse peptide fragments in blood serum as a biomarker for cartilage degradation.
So far, CYT-108 is said to be well-tolerated without any drug-related adverse events reported.
CYT-108 has a “bait” region engineered to increase affinity for specific proteases associated with the molecular pathogenesis of osteoarthritis.
It also has both highly specific and broad-spectrum protease inhibition activity.
The development of CYT-108 builds on the success of Cytonics’ first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system.
A 510(k) medical device, APIC enriches autologous A2M for intra-articular injection into joints affected by arthritis.
Since receiving FDA clearance as a 510(k) device and its market introduction in 2015, APIC is claimed to have demonstrated clinical and commercial success, which in turn supports the potential of CYT-108.
Cytonics president and CEO Joey Bose said: “We are thrilled to have completed enrolment 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 I 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. We are thoroughly impressed by the recruitment efficiency of our clinical sites and look forward to continuing working with these researchers and clinicians as we advance into Phase II.”
