180 Life Sciences Corp. (NASDAQ: ATNF) is currently experiencing an ascent in market activity, exhibiting a notable 17.65% increment to reach $0.60 during the premarket trading session. In the previous trading session, the stock of 180 Life Sciences concluded at $0.51, showing a modest decline of 0.39%. This noteworthy surge is closely associated with the release of pertinent information within a Securities and Exchange Commission filing just the day before.

180 Life Sciences (ATNF) filed that on the 12th of October 2023, it received a formal response from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) concerning a meeting held on August 17, 2023. This pivotal meeting was convened to discuss ATNF’s proposal for using adalimumab as an anti-Tumor Necrosis Factor (TNF) therapy to potentially prevent Dupuytren’s contracture, a disabling condition.

The MHRA’s response was notably constructive. It acknowledged the severity of Dupuytren’s Contracture and concurred with ATNF’s primary and secondary endpoint proposals for a Phase 3 clinical trial. Moreover, the MHRA suggested that a single Phase 3 study could be adequate for Marketing Authorization if it presented compelling evidence of efficacy and safety. However, they emphasized the need for a Phase 3 study due to the uncertainty stemming from ATNF’s Phase 2b trial, which had a limited number of participants.

In parallel, ATNF is actively engaging with the U.S. Food and Drug Administration (FDA) and exploring dialogue with the European Medicines Agency (EMA) to align their clinical development plans with the MHRA’s guidance. They aim to obtain approval for adalimumab as an anti-TNF therapy in the prevention of Dupuytren’s contracture across these regulatory jurisdictions.

In terms of FDA interactions, ATNF has secured the involvement of a prominent biosimilar manufacturer. This manufacturer is willing to participate in discussions regarding the biosimilar’s manufacturing and safety. Additionally, they have expressed interest in supplying the anti-TNF biosimilar drug for the Phase 3 study, though formal agreements are pending and contingent on FDA deliberations.

180 Life Sciences (ATNF) is carefully considering the MHRA’s guidance in ongoing discussions with the FDA and is in the early planning stages for a potential Phase 3 study, provided sufficient funding can be secured.

The MHRA’s response and the collaboration with the biosimilar manufacturer represent significant strides in ATNF’s efforts to gain approval for adalimumab in addressing Dupuytren’s contracture, while the path forward hinges on the outcomes of Phase 3 studies and regulatory engagements with the FDA and potentially the EMA.