180 Life Sciences (NASDAQ: ATNF), a clinical-stage biotechnology company, is sharing an update on its efforts to seek marketing authorization from Medicines and Healthcare Products Regulatory Agency (MHRA) for Anti-TNF treatment of early-stage Dupuytren’s Contracture. ATNF officials, along with representatives from the company’s regulatory consultants from the United States and the United Kingdom, met with MHRA’s scientific advice committee for the second time in October. According to the announcement, 180 Life Sciences presented additional data to MHRA concerning the use of nodule size and hardness as surrogate markers relating to eventual finger contraction in Dupuytren’s disease; the company also asked MHRA officials a series of questions to MHRA. 180 Life Sciences received a formal written response on Nov. 23, 2022. The letter noted that the MHRA had reviewed the primary and secondary endpoints in the Repurposing Anti-TNF for Treating Dupuytren’s Disease (“RIDD”) trial and the data provided by the company and concluded that it has not been shown that reducing nodule size via treatment would lead to improvements in terms of disease progression; the letter requested support for a correlation with clinical outcomes, along with other key support information. 180 Life Science is working to provide that information to MHRA. “Based on the advice of our consultants, the company is planning to prepare a MAA with the aim to submit to the MHRA during 2023,” said 180 Life Sciences CEO Dr. James Woody in the press release. “We see this as the continuation of our clinical and regulatory plan to address the huge unmet medical needs of patients with progressive early-stage Dupuytren’s disease, which affects approximately 4% of the Western population.”
To view the full press release, visit https://ibn.fm/5v4wZ
About 180 Life Sciences Corp.
180 Life Sciences is a clinical-stage biotechnology company driving groundbreaking studies into clinical programs that are seeking to address major unmet medical needs. The company’s focus is a novel program to treat several inflammatory disorders using anti-TNF (tumor necrosis factor). For more information about the company, visit www.180LifeSciences.com.
NOTE TO INVESTORS: The latest news and updates relating to ATNF are available in the company’s newsroom at https://ibn.fm/ATNF
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