180 Life Sciences Provides Update on Correspondence Received from U.K. and U.S. Regulatory Authorities on Pathway for Therapy That Could Prevent Progression of Early-Stage Dupuytren’s Disease

180 Life Sciences Corp. announced receipt of a written response from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and from the U.S. Food and Drug Administration (FDA) related to questions submitted in a Type C meeting request on the Company's planned use of anti-TNF treatment, adalimumab, to treat early-stage Dupuytren's disease. Dupuytren's disease is a common chronic, progressive fibrotic condition of the hand that causes the fingers to curl irreversibly into the palm and can be very disabling.

Approximately 20-35% of patients with a palmar nodule of early-stage Dupuytren's disease progress to finger contractures. Roughly 12 million people in the U.S., 2.5 million in the U.K. and 18 million in the EU have early-stage progressive Dupuytren's disease. Currently, there is no approved treatment for these patients, who must wait until the disease progresses with loss of hand function before undergoing surgery or treatment with collagenase.

Unfortunately, the disease tends to recur after these treatments. The MHRA provided initial feedback following a scientific advice meeting. The agency agreed that there is no need for further non-clinical studies for the planned use of anti-TNF treatment, adalimumab, to treat early-stage Dupuytren's disease and the absence of non-clinical studies can be supported by review of the literature.

The MHRA indicated that while it is biologically plausible that the primary endpoint of nodule hardness and secondary endpoint of nodule size could correlate with disease progression, they would require evidence to validate them as clinically meaningful surrogate endpoints. Without evidence that the endpoints used in the Phase 2b trial are predictive of clinical endpoints and addressing other identified study issues, it is unlikely Phase 2b study would be considered acceptable as a single pivotal study to support a Marketing Authorization Application. The Company is in the process of preparing the evidence to support the Phase 2b endpoints and to address other MHRA concerns.