180 Life Sciences provides update on regulatory process in UK, U.S.

180 Life Sciences submitted a request to the United Kingdom’s Medicines and Healthcare products Regulatory Agency for a follow up scientific advice meeting where the Company will seek guidance on a plan to obtain Conditional Marketing Authorization for the use of adalimumab in the treatment of early stage Dupuytren’s disease. A meeting with the MHRA is anticipated to take place in late Q3 of 2023 with the written responses anticipated to be received prior to year end. The Company’s regulatory consultants have indicated that initiation of an additional clinical trial may be required to obtain CMA approval, and such a trial has been designed. The regulatory consultants of the Company believe that it may be possible to obtain a CMA due to the long safety history of anti-tumor necrosis factor therapies, conditional on a successful Phase 3 trial, which CMA may be granted prior to the completion of the Phase 3 trial, once patients have been enrolled, verifying the commitment of the Company to complete the trial. A CMA would allow the Company to market its therapy for Dupuytren’s disease in the UK, between the granting of the CMA and completion of a successful Phase 3 trial. The Phase 3 trial might utilize sites from various countries, including the United States. Therefore, the Company has submitted a request to the US Food and Drug Administration for a Type C meeting to seek advice as to requirements for obtaining US marketing approval including the potential design requirements of the planned Phase 3 clinical trial. Guidance from the FDA is expected to shape the Company’s clinical development strategy in the US and possibly in other countries. In support of our FDA Type C meeting request, a leading pharmaceutical biosimilar manufacturer will be participating with 180 Life Sciences in the FDA advice discussion. It is anticipated that the advice discussion will take place in late Q3 or early Q4 of 2023. Promising data from a Phase 2b Dupuytren’s treatment trial was published in the June 2022 issue of The Lancet Rheumatology. A follow up publication showed that the therapy likely would be cost effective, and was economically beneficial.