|Aim Immunotech Inc., of Ocala, Fla.||Ampligen (rintatolimod)||Ribonuclease stimulator; 2,5-oligoadenylate synthetase stimulator; TLR-3 agonist; polymerase co-factor VP35 inhibitor||COVID-19||First cohort of 10 healthy subjects dosed at 75 μg with no serious adverse events; plans to escalate to dose level 2 at 200 μg|
|AVM Biotechnology LLC, of Seattle||AVM-0703||Formulation of high concentration of dexamethasone||Relapsed/refractory non-Hodgkin lymphoma||First cohort of 3 patients fully enrolled; drug has been well-tolerated without safety issues|
|Bridge Biotherapeutics Inc., of Seongnam, South Korea||BBT-176||EGFR tyrosine kinase inhibitor||Non-small-cell lung cancer with osimertinib-resistant EGFR triple mutations||Started the 90-patient phase III study; efficacy endpoints include objective response rate, duration of response and progression-free survival|
|Daiichi Sankyo Co. Ltd., of Tokyo||DS-1594||Menin inhibitor||Relapsed/refractory acute myeloid leukemia and acute lymphoblastic leukemia||Dosed first of up to 170 patients in the phase I/II study; primary endpoints for the phase I portion include dose-limiting toxicities, recommended phase II dose and safety profile; secondary endpoints include complete remission rate (CR) and CR with partial hematologic recovery rate|
|Chinook Therapeutics Inc., of Seattle||Atrasentan||Endothelin A receptor inhibitor||Proteinuric glomerular diseases||First patient enrolled in the Affinity study that will enroll 4 initial cohorts of patients with IgA nephropathy (IgAN) with urine protein to creatinine ratio of 0.5 to less than 1 g/g, focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease (DKD) in combination with an SGLT2 inhibitor; primary endpoint is UPCR in patients with IgAN, FSGS and Alport syndrome and urine albumin to creatinine in patients with DKD|
|Horizon Therapeutics plc, of Dublin||Krystexxa (pegloticase)||Uricase stimulator||Gout||Data from the Recipe study published in Arthritis & Rheumatology showed that 86% of patients treated with Krystexxa plus the immunomodulator mycophenolate mofetil achieved serum uric acid ≤ 6 mg/dL at 12 weeks, compared to 40% of patients taking Krystexxa alone|
|Recognify Life Sciences Inc., of New York||RL-007||Targets the cholinergic, NMDA and GABA type B receptor systems||Cognitive impairment associated with schizophrenia||Started the phase IIa study to test the effects of the drug on safety and tolerability, electroencephalograms and cognition|
For more information about individual companies and/or products, see Cortellis.