Company Product Description Indication Status
Phase I
Aldeyra Therapeutics Inc., of Lexington, Mass. ADX-629 Reactive aldehyde species inhibitor Autoimmune disease Clinically relevant plasma concentrations exceeding known levels of RASP observed; reduction in pro-inflammatory RASP malondialdehyde observed in treated participants vs. those who received placebo
Bioinvent International AB, of Lund, Sweden BI-1206 Immunoglobulin gamma Fc receptor IIB antagonist Non-Hodgkin lymphoma  At suboptimal doses in phase I/IIa combination trial with rituximab, 1 participant achieved complete response, 1 with follicular lymphoma remained on treatment for full 1-year maintenance period and 1 with mantle cell lymphoma (MCL) showed complete depletion of circulating MCL cells; dose escalation continues as planned
Calithera Biosciences Inc., of South San Francisco Telaglenastat Glutaminase inhibitor Renal cell carcinoma; triple-negative breast cancer Dose-expansion cohorts in phase I/II combination trial with CDK4/6 inhibitor Ibrance (palbociclib, Pfizer Inc.) and PARP inhibitor Talzenna (talazoparib, Pfizer) in renal cell carcinoma and triple-negative breast cancer paused due to COVID-19 pandemic; enrollment expected to resume in third quarter 2020
Calithera Biosciences Inc., of South San Francisco Telaglenastat Glutaminase inhibitor Colorectal cancer; non-small-cell lung cancer Dose-expansion cohorts in phase I/II combination trial with CDK4/6 inhibitor Ibrance (palbociclib, Pfizer Inc.) in KRAS-mutated disease paused due to COVID-19 pandemic; enrollment expected to resume in third quarter 2020
Calithera Biosciences Inc., of South San Francisco CB-280
Arginase inhibitor
Cystic fibrosis Enrollment delayed until third quarter of 2020 due to COVID-19 pandemic
Cytokinetics Inc., of South San Francisco, and Amgen Inc., of Thousand Oaks, Calif. AMG-594 Cardiac troponin activator Heart failure Enrollment suspended due to COVID-19 pandemic
Phase II
Calithera Biosciences Inc., of South San Francisco Telaglenastat Glutaminase inhibitor Non-small-cell lung cancer Enrollment of first participant in Keapsake trial assessing study drug in those with NRF2/KEAP1 mutation delayed until third quarter of 2020 due to COVID-19 pandemic; interim data expected in 2021
Cytokinetics Inc., of South San Francisco CK-274 Myosin inhibitor Hypertrophic cardiomyopathy Enrollment in Redwood-HCM study paused due to COVID-19 pandemic; data from first cohort may be available in second half of 2020 if cohort's enrollment is completed by midyear 2020
Healios KK, of Tokyo HLCM-051 Multipotent adult progenitor cell therapy Acute respiratory distress syndrome Protocol for ongoing One-Bridge study amended to include additional arm of 5 individuals with pneumonia-induced ARDS caused by COVID-19; results of newly added cohort will be assessed separately from 30 originally planned participants; new cohort not expected to affect progress of originally planned trial
Madrigal Pharmaceuticals Inc., of Conshohocken, Pa. Resmetirom Thyroid hormone receptor beta agonist Nonalcoholic steatohepatitis According to secondary phase II data analysis, once-daily oral 80-mg and 100-mg doses, selected for phase III Maestro-NASH program, delivered at least 50% to > 60% reductions in liver fat, respectively, and were associated with statistically significant 64% NASH resolution (p<0.0001), of which >60% had fibrosis reduction; study drug also produced statistically significantly reduction (p<0.001) in markers of net collagen deposition in NASH, based on paired liver biopsies in phase II study in adults with biopsy-confirmed NASH (NAS ≥4, F1-F3) and hepatic fat fraction ≥10%; Maestro-NASH study continues without modification or delay
Phase III
Astrazeneca plc, of Cambridge, U.K. Calquence (acalabrutinib)  BTK inhibitor COVID-19-related hyperimmunity Calavi trial initiated; part 1 evaluating addition of study drug to best supportive care (BSC) vs. BSC alone in individuals hospitalized with respiratory complications from COVID-19 but not in ICU; part 2 evaluating addition of Calquence to BSC in more severe COVID-19 patients in ICU; primary endpoint is use of assisted ventilation or death
Beigene Co. Ltd., of Beijing Tislelizumab PD-1 inhibitor Non-small-cell lung cancer  Combination trial with pemetrexed and platinum chemotherapy in first-line nonsquamous disease met primary endpoint of statistically significant improvement in progression-free survival vs. pemetrexed and chemotherapy alone at planned interim analysis
Cytokinetics Inc., of South San Francisco, and Amgen Inc., of Thousand Oaks, Calif. Omecamtiv mecarbil  Myosin stimulator Heart failure Enrollment in Meteoric-HF trial paused due to COVID-19 pandemic; risk mitigation for enrolled participants includes remote study visits and home delivery of study drug; site startup activities continue, and enrollment of 270 planned participants may be completed by year-end 2020 if enrollment is reactivated by end of second quarter 2020
Outlook Therapeutics Inc., of Cranbury, N.J. ONS-5010/Lytenava (bevacizumab-vikg) VEGF ligand inhibitor Wet age-related macular degeneration Final enrollment in Norse 2 registration trial expected to be delayed by 1 to 3 months due to COVID-19 pandemic

Notes

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

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