The first patient has been enrolled on a clinical trial to evaluate anti-tumor necrosis factor for patients with early-stage, pain predominant frozen shoulder.
180 Life Sciences, a clinical-stage biotechnology company made the announcement yesterday (August 22).
James Woody chief executive officer of 180 Life Sciences, said: “Recruiting the first patient for the trial of anti-TNF therapy in frozen shoulder patients is a significant milestone.
“Treatment with anti-TNF at the early stage could improve pain and subsequently reduce disability for frozen shoulder patients.”
180 Life Sciences is supporting the study funded by the National Institute of Health and Care Research (NIHR) in the U.K. to investigate whether injections of anti-TNF during the early stages of frozen shoulder can reduce or prevent progression of the disease.
The trial is sponsored by the University of Oxford and is led by Professor Nanchahal, consultant for 180 Life Sciences, together with his colleague Professor Sally Hopewell based at the Oxford Clinical Trials Research Unit, at the University of Oxford.
180 Life Sciences also has the rights for advancing these studies and commercialization of the trial results.
Approximately 50% of patients with Dupuytren’s disease also have frozen shoulder and Professor Nanchahal has previously shown that that TNF, a pro-inflammatory protein, is a key driver of the fibrosis in early-stage Dupuytren’s disease. He led the successful phase 2a(3) and phase 2b(4) clinical trials of anti-TNF for Dupuytren’s disease. This frozen shoulder trial is a multicenter, randomized, double blind placebo controlled clinical trial to assess the feasibility of conducting a phase 3 clinical trial.
Prof Sir Marc Feldmann, executive co-chairman of the company, who is widely recognized for his pioneering work leading up to the first successful use of anti-TNF for treating intractable rheumatoid arthritis, said: “It is a pleasure to see 180 Life Sciences focusing on developing new uses for anti-TNF which has been one of the most successful drug classes of all time, and conducting clinical trials to fulfil unmet needs that anti-TNF can ameliorate.”
Frozen shoulder, or adhesive capsulitis, is very common, affecting about 9% of adults. The early stages are extremely painful and later stages are characterized by stiffness and limitation of motion, which gradually improves. Current treatments include physical therapy and steroid injections, which have modest short-term benefits with no evidence of long-term benefit. Around 40% of patients have persistent stiffness 4 years after onset and may require surgery.