Benzinga | Dec 6, 2021 08:17AM EST

180 Life Sciences Provides Follow-Up Information On Oxford University, Co's Dupuytren's Phase 2b Clinical Trial Results

180 Life Sciences Corp. (NASDAQ:ATNF) ("180 Life Sciences" or the "Company"), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, today provided follow-up information on the top line results of Oxford University and the Company's Phase 2b clinical trial for Dupuytren's disease announced on December 1, 2021.



Dr. James Woody, 180 Life Sciences Chief Executive Officer, stated, "We believe the Phase 2b clinical trial for Dupuytren's disease using adalimumab was a phenomenal achievement, having met both primary and secondary endpoints by significantly diminishing the hardness and size of the Dupuytren's nodules, respectively. We believe these results affirm our team's scientific and clinical expertise and fundamentally position us to be a major leader in fibrosis therapies."

Both the primary and secondary clinical trial endpoints from the Phase 2b clinical trial for patients with early-stage Dupuytren's were statistically significant. Further, patients enrolled in the clinical trial exhibited a high compliance rate; almost all of them returned for all injections, and experienced no related serious adverse events. With approximately 1 in 10 Phase 2b clinical trials for new indications typically succeeding, this positive outcome allows the Company to move closer towards potential commercialization of a much-needed therapy with no currently approved treatment.

However, due to the strict disclosure policies of the prestigious clinical journals, which only permit limited data to be released at closed scientific meetings, the Company is unable at this time to release the entire data set with information that it believes would provide greater clarity around the results. Any further disclosures of the clinical data may disqualify the trial from publication, a situation the Company wishes to avoid. Although publication may be several months away as the peer review process typically involves several iterations of questions and clarifications, publication in a peer-reviewed journal will lend significant credence to the work and represent significant progress in the field of Dupuytren's disease. Professor Nanchahal has already submitted the manuscript to a preeminent clinical journal.

The Company believes it is in an enviable position, with the opportunity to capitalize on the clinical trial results and continue to work towards bringing what it hopes will be a highly efficacious and safe product to market for an unmet need. To its knowledge this is the first rigorous randomized, placebo-controlled, double-blinded trial for preventing the progression of Dupuytren's disease. The Company is not aware of any competitors for targeted therapies for early-stage Dupuytren's disease, and currently possesses rights in connection with a robust, worldwide intellectual property portfolio.

The Company has engaged Kinexum as regulatory consultants to assist in discussions with the U.S. Food and Drug Administration (FDA) and the UK equivalent, the Medicines and Healthcare products Agency (MHRA), to help determine the optimal path forward to commercialization, with initial meetings currently planned for 1H, 2022. Since 2003, Kinexum has been helping clients through the pre-clinical, clinical, CMC development and regulatory process for product candidates targeting a broad range of therapeutic areas through a broad set of modalities.