Company Product Description Indication Status
Phase I
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
Phase II
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

Notes

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