180 Life Sciences ( NASDAQ: ATNF ) closed the recruitment of people with early stage Frozen shoulder in a trial in England after a government agency noted that the study was facing challenges.
The company said the recruitment was being undertaken to decide the feasibility of conducting a trial, dubbed Anti-Freaze-F, to check if an intra-articular injection of anti-TNF (adalimumab) can reduce pain and improve function in people with pain predominant early-stage frozen shoulder.
Adalimumab is sold under as Humira by AbbVie ( ABBV ).
The company noted that the UK research system has faced challenges due to COVID and so the National Institute of Health Research (NIHR) put in place a program called Recovery and Reset to identify and close trials that are facing challenges.
The company's Anti-Freaze-F trial was considered to be one such trial due to the challenges faced in opening recruitment sites and enrolling sufficient people, the company added.
The NIHR has asked the chief investigators to close the study for further recruitment.
The study was being run by the University of Oxford and opened to recruitment at the end of May 2022 after delays in gaining approvals.
Nine people were recruited through mid-February 2023. The study originally sought to recruit 84 people, according to the company.
The people already enrolled will receive their injections and follow up.
The company's request for a no-cost extension was denied.
As per 180 Life Sciences, the closure of the study means that another trial will likely need to be undertaken at a future time to recruit more people.
"We will assess the data from Anti-Freaze-F when available to refine the strategy for any subsequent trials for this unmet need," said 180 Life Sciences CEO James Woody.
ATNF -3.28% to $2.95 premarket Feb. 23
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180 Life Sciences stock dips as recruitment in trial for Frozen shoulder closes amid challenges