|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|
|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|
|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|
For more information about individual companies and/or products, see Cortellis.