Company Product Description Indication Status Date

Phase I

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

Phase II

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

Phase III

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

Notes

The date indicated refers to the BioWorld Clinical data table in which the news item can be found.

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

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