Atopic dermatitis is a systemic inflammatory disorder where both innate immune cells such as dendritic cells (DCs) and adaptive immune cells, such as B and T cells, contribute to cutaneous inflammation. B and T lymphocyte attenuator (BTLA), highly expressed in mature DCs, is crucial to modulate the activity of all immune cells and acts as a co-inhibitory checkpoint receptor.
Researchers from Paragon Therapeutics Inc. presented the preclinical characterization of ORKA-001 (PR-035), a novel half-life extended monoclonal antibody targeting the p19 subunit of IL-23, designed to treat chronic skin disorders such as plaque psoriasis.
The FDA has awarded U.S. orphan drug designation to Eydisbio Inc.’s EYD-001 (formerly HS-276), a highly selective and potent, orally bioavailable TAK1 inhibitor for the treatment of systemic sclerosis. Eydisbio plans to initiate clinical trials in the near future.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH has awarded Resvita Bio a $2.03 million phase II Small Business Innovation Research (SBIR) grant to advance RVB-003, a novel treatment for Netherton syndrome.
Roivant Sciences Ltd. has sold another company, this time offering up Dermavant Sciences Ltd. to Organon & Co. for $1.2 billion. The deal brings Organon into a crowded market for plaque psoriasis treatments. The massive amount comprises an up-front $175 million payment, along with a potential $75 million regulatory milestone and up to $950 million in commercial milestones. In the deal, Organon brings in Vtama (tapinarof) cream, a topical, aryl hydrocarbon receptor agonist for mild, moderate and severe plaque psoriasis in adults.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
Phagocytosis – eliminating millions of dead cells every day – requires specialized cells such as macrophages, the true professionals, which migrate to engulf waste and dying cells.
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