The data demonstrated that tgAAC94, an investigational agent designed to inhibit activity of tumor necrosis factor-alpha (TNF-alpha), a key mediator of inflammation, is well tolerated and may improve disease symptoms in inflammatory arthritis patients.
The Phase I/II study evaluated multiple doses of tgAAC94 administered directly to affected joints with or without concurrent systemic TNF antagonist therapies. The study achieved its primary endpoint of safety and tolerability.
A total of 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. Administration site reactions were observed in 12% of subjects.
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 in the tgAAC94-treated arm versus the placebo arm.
Stewart Parker, president and CEO of Targeted Genetics, said: “We are pleased to have completed this study and are encouraged by the patient-reported symptom improvement. We believe these data suggest further study is warranted and we are evaluating next steps for this program.”