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news.Targeted Genetics has announced positive results from a Phase I/II clinical study of tgAAC94, the company's investigational agent designed to inhibit activity of tumor necrosis factor-alpha, a key mediator of inflammation.
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The Phase I/II study evaluated multiple doses of tgAAC94 administered directly to affected joints with or without concurrent systemic tumor necrosis factor (TNF) antagonist therapies. The study achieved its primary endpoint of safety and tolerability.
In the study, 127 patients with inflammatory arthritis received a single intra-articular injection of either tgAAC94 or placebo, followed by a second injection 12-30 weeks later depending on when the injected joint met criteria for re-injection. tgAAC94 was well tolerated at all dose levels and was found to improve disease symptoms in inflammatory arthritis patients refractory to other therapies, including systemic TNF antagonists.
Preliminary signs of efficacy were also observed in the study, most notably a 30% decrease in patient-reported pain and functional scores as measured by the global visual analog scale (VAS) in the tgAAC94-treated arm versus the placebo arm. Global VAS is an assessment tool to help patients describe the intensity of their pain and functional capacity.