Company Product Description Indication Status
Phase I
Ansun Biopharma Inc., of San Diego DAS-181 Exo-alpha sialidase modulator COVID-19 infection First of about 22 participants with severe disease dosed in U.S. in proof-of-concept adaptive design trial; following interim review, about 60 additional participants expected to be enrolled in U.S. and Europe
Arvinas Inc., of New Haven, Conn. ARV-471 Estrogen receptor alpha antagonist Metastatic breast cancer Pause in trial enrollment at UCLA site lifted and additional participants with ER+/HER2- locally advanced or metastatic disease permitted to enroll; clinical data on track to report in second half of 2020
Gensight Biologics SA, of Paris GS-030 Channel rhodopsin gene stimulator Retinitis pigmentosa Data safety monitoring board (DSMB) confirmed no safety issues for second cohort of 3 participants in phase I/II Pioneer study; each received single intravitreal injection of 1.5e11 viral genomes (vg) prior to using wearable optronic visual stimulation device; DSMB recommended trial continue without modification; recruitment of third cohort of 3 participants to receive maximal dose of 5e11 vg delayed due to COVID-19 pandemic but expected to complete in second half of 2020
Ico Therapeutics Inc., of Vancouver, British Columbia ICO-019 (amphotericin B, oral) Macrolide antibiotic Infection In phase Ib study, repeated 100-mg and 400-mg doses were well-tolerated with no serious adverse events; 100-mg dose achieved median plasma Cmax of 25 ng AmB/mL and AUC (0-inf) 990 hr ng/mL after day 1 of dosing and median plasma Cmax of 44 ng AmB/mL and AUC (0-inf) 1998 hr ng/mL after 10 days of dosing; approximate doubling of AUC measure between days 1 and 10 observed both at 100-mg and 400-mg doses; start of phase II trial delayed due to COVID-19 pandemic
Phase II
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 chemokine antagonist COVID-19 infection First of about 390 participants with severe infection dosed in phase IIb/III study; primary endpoint is mortality rate at 28 days, with secondary endpoint of mortality rate at 14 days; interim analysis expected on data from 50 participants
Oragenics Inc., of Tampa, Fla. AG-013 Trefoil factor-1 stimulator Oral mucositis Top-line results in head and neck cancer patients who received chemoradiation showed study drug did not achieve statistical significance vs. placebo on primary endpoint of severe oral mucositis duration; ongoing analyses to determine potential efficacy for subpopulations
Phase IV
Mallinckrodt plc, of Staines-upon-Thames, U.K. Acthar Gel (repository corticotropin injection) Adrenocorticotrophic hormone ligand Rheumatoid arthritis Findings from 2-part study of 259 adult participants that showed 65.3% (p<0.001) achieved low disease activity at week 12 during open-label therapy, with effect maintained in 85.7% (n=66) vs. 65.8% (n=50) in placebo group (p=0.004) treated for 12 additional weeks in double-blind phase, published in Rheumatology and Therapy 

Notes

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