- 180 Life Sciences Corp (NASDAQ:ATNF) received a written response from the U.K.'s regulatory agency and U.S. FDA related to questions submitted in a Type C meeting request for anti-TNF treatment, adalimumab, to treat early-stage Dupuytren's disease.
- Dupuytren's disease is a progressive fibrotic condition of the hand that causes the fingers to curl irreversibly into the palm and can be very disabling.
- The U.K. agency indicated that while it is biologically plausible that the primary endpoint of nodule hardness and the secondary endpoint of nodule size could correlate with disease progression, they would require evidence to validate them as clinically meaningful surrogate endpoints.
- Without evidence, the Phase 2b trial is unlikely to be considered acceptable as a single pivotal study to support the marketing application.
- The company is in the process of preparing the evidence to support the Phase 2b endpoints and to address other MHRA concerns.
- The FDA indicated that the proposed outcome measures of nodule hardness and nodule size are not clinical outcome measures that measure how a patient feels, functions, or survives, which would be needed to support a demonstration of efficacy in registrational studies.
- Price Action: ATNF shares are down 37.31% at $0.84 during the premarket session on the last check Wednesday.
