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II","country":"BELGIUM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"UCB Pharma S.A"},{"orgOrder":0,"company":"Nimbus Therapeutics","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"D","amount":"$6,000.0 million","upfrontCash":"$4,000.0 million","newsHeadline":"Takeda to Acquire Nimbus Therapeutics\u2019 Highly Selective, Allosteric TYK2 Inhibitor to Address Multiple Immune-Mediated Diseases","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Nimbus Therapeutics"},{"orgOrder":0,"company":"MoonLake Immunotherapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody\u00ae sonelokimab in active psoriatic arthritis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"MoonLake Immunotherapeutics"},{"orgOrder":0,"company":"Regimmune","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"REGiMMUNE Presented Positive Results of RGI-2001 in the Reduction of Acute GvHD from Phase 2b Study at the 2022 ASH Annual Meeting","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"TAIWAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Regimmune"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics plc Announces First Patient Enrolled in Phase 2 Trial Evaluating Daxdilimab for the Treatment of Discoid Lupus Erythematosus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"Blueprint Medicines","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Blueprint Medicines Reports Clinical Data Highlighting Leadership in Developing Targeted Treatment Options for Patients with Systemic Mastocytosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Blueprint Medicines"},{"orgOrder":0,"company":"Horizon Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sj\u00f6gren\u2019s Syndrome Meets Primary Endpoint in the Second Study Population; Only Phase 2 Trial to Meet Primary Endpoint in Both Patient Populations","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Horizon Therapeutics"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Benlysta Granted Orphan Drug Designation by US FDA For the Potential Treatment of Systemic Sclerosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"}]
Find Immunology Drugs in Phase II Clinical Development
Tolebrutinib is an investigational brain-penetrant Bruton’s tyrosine kinase inhibitor that achieves CSF concentrations needed for targeting B lymphocytes and microglial cells, modulating neuroinflammation.
RINVOQ® (upadacitinib) is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. SELECT-AXIS 2 is the first trial to evaluate efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.
The Phase 2 study (KD025-215) will enroll up to 15 adults with dcSSc who will receive orally administered belumosudil 200 mg twice daily (BID). Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2).
In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil has been extended to August, 2021.
Kadmon plans to use a part of the proceeds to prepare to commercialize belumosudil for chronic graft-vs-host disease in the U.S; for its clinical-stage product candidates; for discovery and preclinical studies of other product candidates; and for general corporate purposes.
The presentation will include 12-month efficacy and safety data and key secondary endpoints including duration of response, Failure-Free Survival, steroid dose reductions and quality-of-life improvements.
The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD who failed two or more lines of systemic therapy.
The multicenter Phase 2A trial is anticipated to enroll approximately 25 patients with active IgG4-RD in two arms, rilzabrutinib with glucocorticoids or glucocorticoids only.
Belumosudil is being studied in an ongoing double-blind, placebo-controlled Phase 2 clinical trial in adults with SSc. The study is enrolling 60 patients to receive belumosudil 200 mg QD, belumosudil 200 mg BID or placebo for 24 weeks.
Data show the clinical activity of ABBV-3373 and support advancing the development of the platform in rheumatoid arthritis and initiating clinical studies in other immune-mediated diseases.
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