180 Life Sciences Begins Consultations with UK and US Regulatory Authorities on Pathway for a Therapy that Could Prevent Progression of Early-Stage Dupuytren’s Disease
PALO ALTO, Calif., May 31, 2022 (GLOBE NEWSWIRE) — 180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the “Company”), a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain, today announced, following publication of promising data from a Phase 2b Dupuytren’s trial in the June 2022 issues of The Lancet Rheumatology, that 180 Life Sciences has initiated preliminary consultations with regulatory agencies in both the UK and USA, with the assistance of Kinexum, the Company’s regulatory advisor.
At a scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (UK MHRA), on May 18, 2022, the Company presented the results of the Phase 2b trial and received guidance on the path forward for further development. The Company awaits formal feedback from UK MHRA.
The U.S. Food and Drug Administration (US FDA) has agreed to provide a written response to the Company’s briefing materials including the results of the Phase 2B trial, on a Type C meeting request. Guidance from the FDA is expected to shape the Company’s clinical development strategy in the USA.
“We believe our recent results present the potential for an earlier treatment for patients with Dupuytren’s disease, which is easy to diagnose at an early stage,” said James Woody, M.D., Chief Executive Officer of 180 Life Sciences, who continued, “We look forward to feedback from the regulatory agencies which we believe may help us bring this potential treatment to patients to prevent the disease from advancing to the stage that surgery is needed to maintain hand function.”
Fibrosis of the hand, known as Dupuytren’s disease, is a common chronic, progressive condition that causes the fingers to curl irreversibly into the palm and can be very disabling. Approximately 20-35% of patients with a palmar nodule progress to finger contractures. Based on our analysis of publicly available data, we estimate that approximately 12 million patients in the U.S., 2.5 million in the U.K. and 22 million in the EU have Dupuytren’s disease. Currently, there is no approved treatment for early-stage disease and patients 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 Phase 2b trial1 was designed as a randomized, double-blind, placebo-controlled study to assess the efficacy of local injection of anti-Tumor Necrosis Factor (TNF) treatment, adalimumab, in participants with early-stage Dupuytren’s disease and was led by Professor Jagdeep Nanchahal, clinician-scientist at the University of Oxford and Chairman of the Clinical Advisory Board at 180 Life Sciences who said: “This trial represents the clinical translation of our laboratory findings where we identified of TNF as a therapeutic target2,3, and the Phase 2a dose ranging clinical trial to identify the optimal dose and formulation4 effective in downregulating myofibroblasts”, the cells that generate the cords that cause the fingers to curl into the palm. The trial recruited 140 patients from two sites in the U.K. Patients were randomized 1:1 to the treatment arm or placebo. Patients in the treatment arm received four injections of 40mg adalimumab in 0.4ml at baseline, which was determined to be most efficacious in the earlier Phase 2a study, at three, six and nine months. Patients were followed up at 12 and 18 months. Eligibility criteria included adults with early-stage Dupuytren’s disease and a clinically distinct nodule with a clear history of progression in the preceding six months. The trial was funded by the Health Innovation Challenge Fund (Wellcome Trust, Department of Health and Social Care) and 180 Life Sciences, and sponsored by the University of Oxford.
References
1. J. Nanchahal, Anti-Tumour Necrosis Factor Therapy for Early Stage Dupuytren’s Disease (RIDD): a phase 2b randomised double blind, placebo-controlled trial. The Lancet Rheumatology. 4, (e407-e416) (2022).
2. L. S. Verjee, Unraveling the signaling pathways promoting fibrosis in Dupuytren’s disease reveals TNF as a therapeutic target. PNAS. 110 (10), E928-E937 (2013).
3. D. Izadi, Identification of TNFR2 and IL-33 as therapeutic targets in localized fibrosis. Science Advances. 5(12), eaay0370 (2019).
4. J. Nanchahal, Anti-Tumour Necrosis Factor Therapy for Dupuytren’s Disease: A Randomised Dose Response Proof of Concept Phase 2a Clinical Trial. EBioMedicine. 33, (282-288) (2018).
About 180 Life Sciences Corp.
180 Life Sciences Corp. 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 one of the leaders 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. The Company’s primary platform is a novel program to treat fibrosis using anti-TNF (tumor necrosis factor).
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