|Ampio Pharmaceuticals Inc., of Englewood, Colo.||Ampion||Stem cell antigen-1 inhibitor||COVID-19 infection||First of about 10 participants dosed in U.S. trial evaluating 5-day I.V. formulation in infected adults who require supplemental oxygen; primary endpoint is safety and tolerability||7/23/20|
|Ascentage Pharma Group International, of Suzhou, China||APG-115||MDM2-p53 inhibitor||Hematological malignancy||Phase Ib single agent/combination study in relapsed/refractory acute myeloid leukemia or relapsed/progressed high/very high-risk myelodysplastic syndrome dosed first participant in China||7/22/20|
|Cerecor Inc., of Rockville, Md.||CERC-002||Tumor necrosis factor 14 ligand inhibitor||COVID-19-induced acute respiratory distress syndrome||First of about 82 hospitalized individuals enrolled in proof-of-concept study evaluating effect of single dose of study drug; primary outcome measures are respiratory failure and death vs. standard of care at 28 days; key secondary endpoints include ICU and hospital lengths of stay and oxygen saturation at end of study; top-line data expected in fourth quarter of 2020||7/21/20|
|Clarity Pharmaceuticals Ltd., of Sydney||67Cu-Sartate||Peptide receptor radionuclide therapy||Neuroblastoma||Enrollment opened in phase I/IIa trial in pediatric patients with high-risk disease||7/23/20|
|Hutchison China Meditech Ltd., of Hong Kong||HMPL-306||Selective small-molecule inhibitor of IDH1/2||Relapsed or refractory hematological malignancies||Dosed first patient; study enrolling patients whose disease has IDH1 and/or IDH2 mutation||7/24/20|
|Opthea Ltd., of Melbourne, Australia||OPT-302||VEGF-C/VEGF-D ligand inhibitor||Diabetic macular edema||Updated data from phase Ib/IIa trial in subset who received at least 3 consecutive aflibercept injections on regular basis before enrollment (n=35) showed mean improvement in BCVA of +6.6 letters (n=22) from baseline to week 12 in study drug + aflibercept combination vs. +3.4 letters (n=13) for those continuing on aflibercept monotherapy; proportion of those gaining ?10 letters from baseline to week 12 was 27.3% for combination vs. 0% for aflibercept monotherapy and proportion gaining ?15 letters to week 12 was 9.1% for combination vs. 0% for monotherapy; improved anatomical changes were consistent with functional visual acuity outcomes||7/27/20|
|AI Therapeutics Inc., of Guilford, Conn.||LAM-002A (apilimod dimesylate)||PIKfyve kinase inhibitor||COVID-19 infection||Trial initiated and expected to enroll 142 outpatients; primary efficacy endpoint is reduction of viral load in those with confirmed infection; additional efficacy measures include death, hospitalization and oxygen saturation||7/27/20|
|Cytodyn Inc., of Vancouver, Wash.||Leronlimab (PRO-140)||CCR5 antagonist||COVID-19 infection||Safety data from 84 participants treated across 8 sites showed 34% (19 of 56) in leronlimab arm reported at least 1 serious adverse event (SAE) vs. 50% (14 of 28) in placebo arm; no SAEs in leronlimab arm deemed related to study drug||7/21/20|
|Immunic Inc., of New York||IMU-838||DHODH inhibitor||COVID-19 infection||First of about 120 hospitalized participants enrolled in investigator-sponsored phase IIb Ionic combination trial with oseltamivir (Tamiflu, Roche Holding AG) in adults with moderate to severe infection||7/27/20|
|Moderna Inc., of Cambridge, Mass.||mRNA-1273||COVID19 Spike glycoprotein modulator||COVID-19 infection||First of about 30,000 participants dosed in U.S. Cove study; primary endpoint is prevention of symptomatic disease; analysis will be event-driven based on number of participants with symptomatic disease||7/27/20|
The date indicated refers to the BioWorld Clinical data table in which the news item can be found.
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