Insmed drug Brinsupri failed to beat a placebo in a mid-stage clinical trial testing the daily pill as a treatment for hidradenitis suppurativa, a chronic inflammatory skin disorder. Brinsupri is still projected to become a blockbuster seller in non-cystic fibrosis bronchiectasis, where it is the first approved therapy for this chronic lung condition.
Startup Pinnacle Medicines is developing peptide drugs with the same efficacy as biologic medicines and the dosing convenience of oral small molecules. The lead program of OrbiMed-incubated Pinnacle is on track to enter the clinic in asthma and chronic obstructive pulmonary disease.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Biogen’s Apellis Pharmaceuticals acquisition comes nearly two years after the drugmaker purchased immunology startup Human Immunology Biosciences. CEO Chris Viehbacher said Apellis accelerates Biogen’s expansion in nephrology, supporting a HI-Bio drug currently in pivotal testing for three kidney conditions.
Alumis’s genomic research guided its development of envudeucitinib, a TYK2 inhibitor that some analysts now view as best in class. The Phase 3 results that will support a planned FDA submission in plaque psoriasis are scheduled for presentation this weekend during the American Academy of Dermatology annual meeting in Denver.
Gilead Sciences is acquiring Ouro Medicines, a startup developing T cell engagers for a range of autoimmune diseases. Separately, Gilead is negotiating a deal with Galapagos to share in the development and potential commercialization of the Ouro drug.
FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.
How to turn analytics into actual policy outcomes.
Povetacicept, a Vertex Pharmaceuticals immunology drug designed to block two targets, met the main goal of a Phase 3 clinical trial in the rare kidney disease immunoglobulin A nephropathy. The fusion protein came from Vertex’s acquisition of Alpine Immune Sciences, and analysts say the drug has best-in-class potential.
Along with the reverse merger, Candid Therapeutics announced $505 million in private financing to support its pipeline of T cell engagers for autoimmune disease. Lead program cizutamig is on track to begin global Phase 2 testing in myasthenia gravis and interstitial lung disease.
Boehringer Ingelheim receives rights to oral small molecules from Sitryx with potential applications in multiple autoimmune disorders. Depending on the progress of Boehringer’s research, Sitryx could receive more than $500 million.
CSL Limited retains rights to clazakizumab in end-stage kidney disease. Eli Lilly gets rights to the the IL-6-blocking antibody in other indications that could put it in competition with Novo Nordisk and Novartis.
Enterprise EHR boosts scalability, interoperability, and governance for large healthcare systems.
Evommune’s EVO301 met the goals of a placebo-controlled Phase 2a study in atopic dermatitis. The biologic drug neutralizes a signaling protein involved in multiple inflammatory pathways, which could differentiate it from the blockbuster Sanofi and Regeneron Pharmaceuticals immunology drug Dupixent.
Brepocitinib is on track for pivotal testing after meeting the goals of a proof-of-concept study in cutaneous sarcoidosis, a rare inflammatory skin disorder with no FDA-approved therapies. Roivant Sciences subsidiary Priovant Therapeutics licensed the dual JAK1 and TYK2 inhibitor from Pfizer.
Rapt Therapeutics brings to GSK ozureprubart, a long-acting antibody that inhibits the validated immunology target immunoglobulin E (IgE). If GSK is able to bring this drug to the market, it would complete with the blockbuster Genentech and Novartis allergy drug Xolair.
Cancer drugs are always popular biotech investments, but autoimmune disease also figures prominently in the startup financings announced during the annual J.P. Morgan Healthcare Conference this year.
Ventyx Biosciences’ lead program, an oral small molecule inhibitor of NLRP3, has encouraging clinical data from separate mid-stage tests in cardiovascular disease and Parkinson’s disease. Eli Lilly said Ventyx’s pipeline has potential applications in cardiometabolic health, neurodegeneration, and autoimmunity.