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INmune Bio Announces Plan to Submit FDA Biologics License Application (BLA) Seeking Approval of CORDStrom for Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
The Company reports results of a double-blinded, randomized, placebo-controlled study, known as “MissionEB,” investigating CORDStrom for treatment of RDEB in
About this update from Inmune Bio Inc.
[{"type":"text","content":"The Company reports results of a double-blinded, randomized, placebo-controlled study, known as “MissionEB,” investigating CORDStrom for treatment of RDEB in pediatric patients, which evidence a favorable benefit-risk profile in support of the intended applications for marketing authorization. CORDStrom, developed by INmune Bio is a patent pending, off the shelf, advanced mesenchymal stromal cell (MSC) platform developed to treat complex inflammatory diseases that has significant clinical development advantages over current MSC products.FDA grants CORDStrom a Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for treatment of epidermolysis bullosa (EB).Parallel efforts will seek marketing authorizations in the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).Investor Webcast Today at 8:30 a.m. ET. Boca Raton, Florida, Feb. 10, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today, following a Type C meeting with the U.S. Food and Drug Administration (FDA), its intent to submit a BLA in the US and Marketing Authorization Application (MAA) in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients. RDEB is a rare, severely debilitating genetic disease, which has its onset in early childhood. Patients' skin is extremely fragile and is easily damaged, resulting in painful and itchy blistering wounds and scarring that can lead to aggressive and life-threatening skin cancer in adulthood. Long-term morbidity is driven by a debilitating itch and pain that significantly exacerbates wounds and deeply affects quality of life. The currently available treatments target active lesions via topical administration and have a limited benefit. The Company estimates roughly 4,500 children with intermediate or severe RDEB in the US, UK and EU may benefit from systemic CORDStrom therapy (all RDEB incidence: 95 per million live births, at least ~37% of all RDEB are RDEB intermediate or severe), which represents a large unmet opportunity to potentially provide routine clinical care to these ...