180 Life Sciences Corp. announced closure to recruitment of men and women across England with early stage Frozen shoulder
for a trial to determine the feasibility of conducting a large randomized controlled trial to assess whether an intra-articular injection of anti-TNF (Adalimumab) can reduce pain and improve function in people with pain predominant early-stage frozen shoulder, which was called the Anti-Freaze-F trial. The Anti-Freaze-F trial is being run by the University of Oxford and originally sought to recruit 84 participants. Frozen shoulder is an extremely painful and debilitating condition, affecting about 9% of adults in the UK. It is characterized by an initial pain predominant inflammatory phase that lasts around 3-9 months. This progresses to a stiffness predominant phase with restriction of shoulder movement, followed by slow improvement in motion and stiffness. Administration of steroids generally leads to improvement in pain and motion, but the effects do not typically extend beyond 6 weeks. The Anti-Freaze-F trial opened to recruitment at the end of May 2022 following delays in gaining approvals due to backlogs in the National Institute of Health Research (NIHR) system due to COVID-19 and consequential staff vacancies. Nine participants were recruited for participation in the trial through mid-February 2023. The UK research system has faced unprecedented challenges following the COVID-19 pandemic both in terms of support services and at the point of delivery of clinical care. This has resulted in the NIHR instituting their Recovery and Reset programme to identify and close trials that are facing challenges. Unfortunately, the company recently learned that the company's Anti-Freaze-F trial was considered to be one of the very numerous trials deemed one of such trials, due to the considerable challenges the company faced to open recruitment sites and enroll sufficient participants. Therefore, the NIHR has asked the chief investigators to close the trial for further recruitment. The participants enrolled to date will receive their injections and follow up according to the established protocol. The Company had previously requested a no-cost extension, which was denied. The result of the closure of the trial means that another trial will likely need to be undertaken at a future time to recruit additional participants.