180 Life Sciences (NASDAQ: ATNF), a clinical-stage biotechnology company, has closed recruitment in England for its anti-TNF frozen shoulder trial. The company had been enrolling men and women with early-stage frozen shoulder to participate in the study, which was called the Anti-Freaze-F trial. The study was designed to evaluate whether an intra-articular injection of anti-TNF (Adalimumab) would reduce pain and improve function in people with pain predominant early-stage frozen shoulder. The study, which was being run by the University of Oxford, was originally planning to recruit 84 individuals. However, several delays occurred, including gaining approvals because of COVID-19-caused backlogs in the National Institute of Health Research (“NIHR”) system and staff vacancies.
Ultimately, nine participants have been recruited for participation in the trial thus far. The NIHR has identified trials that are facing challenges and requesting that those trials close; ATNF’s Anti-Freaze-F trial was classified as one of those based on enrollment and recruitment issues. The announcement noted that enrolled participants will receive their injections and follow up, and another trial will likely need to be undertaken at a future time. “The challenges faced by the United Kingdom National Health Service and the systems associated with delivery of clinical research have made it extremely difficult to conduct some clinical trials, especially those initiated soon after the COVID-19 pandemic,” said 180 Life Sciences CEO Dr. James Woody in the press release. “We will assess the data from Anti-Freaze-F when available to refine the strategy for any subsequent trials for this unmet need. We are confident in the scientific rational for the study, and in the future, we may determine that this trial may be best conducted in another country where the health and research systems are less constrained, and patients are readily available. This option is currently under consideration.”
In addition, the company also announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for a patent. The patent, titled “Method of Treating Dupuytren’s disease Using a Pre-filled Syringe,” covers claims related to the use of a citrate-free formulation of 40mg in 0.4mL of adalimumab to be injected into nodules of early-stage Dupuytren’s disease every 3 months over a period of 12 months; the injections are administered using a syringe with a 25-gauge needle. According to the announcement, USPTO issues the notice after it determines that a patent should be granted; the company anticipates receiving the patent in the coming months.
To view the full press releases, visit https://ibn.fm/3tJrz and https://ibn.fm/L2j8G
About 180 Life Sciences Corp.
180 Life Sciences is a clinical-stage biotechnology company driving groundbreaking studies into clinical programs that are seeking to address major unmet medical needs. The company’s focus is a novel program to treat several inflammatory disorders using anti-TNF (tumor necrosis factor). For more information about the company, visit www.180LifeSciences.com.
NOTE TO INVESTORS: The latest news and updates relating to ATNF are available in the company’s newsroom at https://ibn.fm/ATNF
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