Company Product Description Indication Status
Phase I
Astrazeneca plc, of Cambridge, U.K. AZD-7442 Combination of two monoclonal antibodies derived from convalescent patients infected with SARS-CoV2 Healthy participants (eventually COVID-19) Started the NCT04507256 study of 48 healthy participants
Byondis BV, of Nijmegen, the Netherlands [Vic-]trastuzumab duocarmazine (SYD-985)  Antibody-drug conjugate targeting HER2 HER2-expressing locally advanced or metastatic solid tumor Treated first of up to 120 patients in the SYD985.004 study testing drug in combination with Zejula (niraparib, Glaxosmithkline); study includes dose escalation and dose expansion phases
Krystal Biotech Inc., of Pittsburgh KB-301 Full-length human type III collagen transgene Acne scars and facial wrinkles Started the Pearl-1 study of 22 patients in 3 cohorts; cohort 1 will evaluate safety and tolerability of 2 dose levels; cohorts 2 and 3 will measure safety and efficacy in either shallow to moderately deep facial wrinkles or moderate to severe atrophic acne scars
Mereo Biopharma Group plc, of London Alvelestat  Neutrophil elastase inhibitor Hospitalized, moderate to severe COVID-19 respiratory disease Started placebo-controlled study of approximately 15 patients; primary endpoints of the trial are safety and tolerability; blood biomarkers (NETosis, inflammation and hypercoagulation) oxygen deficit, need for respiratory support and disease severity will also be measured
Union Therapeutics A/S of Hellerup, Denmark UNI-911 Inhaled optimized salt form of the anthelmintic niclosamide Healthy participants (eventually COVID-19) Study of 44 volunteers across 5 cohorts found the drug was safe and tolerable; preparing to advance drug into a study in patients
Phase II
Immunovant Inc., of New York IMVT-1401  Dual IgG receptor FcRn large subunit p51 antagonist/modulato  Myasthenia gravis Pooled data from 2 doses showed drug improved Myasthenia Gravis Activities of Daily Living by a mean of 3.8 points compared to a 0.6-point decline for placebo (p=0.029); drug improved average Myasthenia Gravis Composite by 8.0 points compared to a mean decline of 1.4 points for placebo (p=0.006); mean reductions in total IgG from baseline for the 340-mg and 680-mg cohorts were 59% and 76%, respectively  
Ovid Therapeutics Inc., of New York, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Soticlestat  Inhibitor of cholesterol 24-hydroxylase Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) In the combined indications; drug reduced median convulsive seizure and drop seizure frequency by 27.8% compared to a 3.1% increase in patients taking placebo during the 12-week maintenance period (p=0.0007); reduction was 29.8% for drug and 0% for placebo during the full 20-week treatment period (p=0.0024); individually, placebo-adjusted decline for DS cohort was statistically significant, but LGS cohort was not
Phase III
Bavarian Nordic A/S, of Copenhagen, Denmark Freeze-dried formulation of MVA-BN Small pox vaccine Small pox prophylaxis The 3 lots of freeze-dried MVA-BN induced equivalent antibody responses
Bristol Myers Squibb Co., of New York Idhifa (enasidenib) Inhibitor of IDH2 Relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation Idhentify study didn't meet primary endpoint of overall survival; data to be presented at a future medical meeting
Ipsen SA, of Paris Palovarotene  Retinoic acid receptor gamma agonist  Fibrodysplasia ossificans progressiva Post hoc analysis of the Move study that was paused when futility criteria were met at a prespecified interim analysis found a 62% reduction in mean annualized new HO volume in participants treated with palovarotene (8,821 mm3) versus untreated (23,318 mm3) patients

Notes

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