180 Life Sciences Corp (ATNF) Confirms Collection of All Patient Data for Phase 2b Dupuytren’s Disease Trial
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180 Life Sciences Corp. (NASDAQ: ATNF) today announced that all patient data for the Phase 2b Dupuytren’s disease clinical trial has been collected and submitted for analysis and review.
The trial is sponsored by the University of Oxford and funded by the Wellcome Trust and UK Department of Health with a contribution from 180 Life Sciences. In this double-blind placebo-controlled trial, 181 patients were randomized across 3 sites, two in the UK and one in the Netherlands. The nodule was injected on up to four occasions at three-month intervals with 40mg adalimumab in 0.4ml or an equivalent volume of placebo, and the patients followed for a further 6 months. Follow up was delayed by the COVID-19 pandemic. The data is currently being analyzed and is planned to be published in a peer-reviewed journal in an open access format. At that stage the Company will announce the top line data.
Dr. James Woody, 180 Life Sciences Chief Executive Officer commented, “Despite the challenges posed by the COVID-19 pandemic and shut down of clinical sites across Europe due to government restrictions, we are fortunate to have had our investigators with the help of additional support from the Wellcome Trust, complete the collection of data. The data is being reviewed and validated, which is not an easy task under current conditions. The analysis will be according to the previously agreed Statistical Analysis Plan. We remain on track to announce a top-line data read out from this trial in Q4 2021.”
Currently there is no approved therapeutic for preventing early stage Dupuytren’s disease and patients who develop finger contractures can struggle with many activities of daily living. Treatments for late-stage disease all have significant shortcomings.
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