180 Life Sciences (NASDAQ: ATNF), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, has shared progress status on the company’s anti-TNF treatment, adalimumab, designed to treat early-stage Dupuytren’s disease. The company has reached out to the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”) and the U.S. Food and Drug Administration (“FDA”) to request a Type C meeting regarding adalimumab; the company noted that it has received a written response from both entities to this request. The MHRA’s response was sent following a scientific advice meeting, noting that the agency sees no need for further nonclinical studies for the planned use of adalimumab to treat early-stage Dupuytren’s disease and that it is unlikely a phase 2b study would be considered acceptable as a single pivotal study to support a marketing authorization application. In response, 180 Life Sciences is preparing evidence to address MHRA’s concerns. The FDA’s response recommended considering a pre-investigational new drug (“PIND”) meeting request to receive further regulatory guidance, which the company plans to request. According to the announcement, Dupuytren’s disease is a common chronic, progressive fibrotic, disabling condition of the hand that results in the fingers curling irreversibly into the palm. An estimated 20% to 35% of patients with a palmar nodule of early-stage Dupuytren’s disease progress to finger contractures. Roughly 12 million people in the United States have early-stage progressive Dupuytren’s disease with another 2.5 million in the United Kingdom and 18 million in the European Union. Currently, there is no approved treatment for these patients.
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About 180 Life Sciences Corp.
180 Life Sciences is a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain by leveraging the combined expertise of luminaries in therapeutics from Oxford University, the Hebrew University and Stanford University. 180 Life Sciences is leading the research into solving one of the world’s biggest drivers of disease — inflammation. The company is driving groundbreaking studies into clinical programs, which are seeking to develop novel drugs addressing separate areas of inflammation for which there are no effective therapies. 180 Life Sciences’ primary platform is a novel program to treat fibrosis using anti-TNF (“TNF”) (tumor necrosis factor). For more information about the company, visit www.180LifeSciences.com.
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