Company Product Description Indication Status Date

Phase I

AIM Immunotech Inc., of Ocala, Fla. Ampligen and interferon alpha-2b TLR-3 agonist; interferon type I receptor agonist; ribonuclease stimulator; 2,5-oligoadenylate synthetase stimulator Cancer and mild to moderate COVID-19 Institutional review board approved protocol amendment to ongoing phase I/IIa study testing 2-drug combination as potential early-onset treatment, calling for randomization of additional 20 patients 3/22/21
Ampio Pharmaceuticals Inc., of Englewood, Colo. AP-014 (inhaled Ampion) Stem cell antigen-1 inhibitor Respiratory distress as a result of COVID-19 Preliminary results demonstrated improvement in all-cause mortality vs. standard of care (SOC); lower all-cause mortality rate of 8% observed for Ampion group vs. 21% in SOC alone; patients receiving Ampion required less hospitalization, with average hospital stay of 7 days vs. 11 days for SOC; patients required less oxygen on Ampion, and 86% of Ampion patients were stable or had improvement compared to 75% of SOC; by day 5, 86% on Ampion were stable or had improvement compared to 75% on SOC 3/16/21
Harbour Biomed Holdings Ltd., of Suzhou, China HBM-4003 Cytotoxic T-lymphocyte protein-4 inhibitor Advanced melanoma and other solid tumors Dosed first patient in study testing combination with PD-1 drug teriprizumab 3/22/21
Histogen Inc., of San Diego, and Amerimmune LLC, of Fairfax, Va. Emricasan Pan-caspase inhibitor Mild symptomatic COVID-19 Treated first patient in the placebo-controlled study testing the safety and tolerability of the drug; study will also measure FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool 3/16/21
Noxopharm Ltd., of Sydney Veyonda Topoisomerase inhibitor and radiopharmaceutical COVID-19 Approved to move into second and final stage of Noxcovid-1 trial; in part 1, 1,800-mg dose was deemed sufficiently well-tolerated in patients with moderate COVID-19 to become preferred dose; part 2 will recruit minimum of 10 and up to 15 patients with moderate to severe lung dysfunction 3/18/21

Phase II

Bioage Labs Inc., of Richmond, Calif. BGE-175 PGD2 antagonist COVID-19 infection Trial initiated in 132 people ? 60 years old hospitalized with infection and not yet in respiratory failure; primary endpoint is proportion who die or progress to respiratory failure within 28 days of initial dose; top-line results expected by year-end 2021 3/22/21
Biophytis SA, of Paris Sarconeos (20?hydroxyecdysone, BIO-101) Proto-oncogene Mas agonist COVID-19 infection Data monitoring committee for phase II/III Cova study in people 45 and older hospitalized with infection and severe respiratory effects issued favorable opinion on safety following scheduled interim analysis of 50 participants from part 1 and progression of enrollment, now at 97 of 155 needed for second interim analysis 3/22/21
Curevac NV, of T├╝bingen, Germany CVnCoV (SARS-CoV-2 mRNA vaccine) COVID-19 spike glycoprotein modulator COVID-19 infection Ongoing pivotal phase IIb/III Herald trial expected to include efficacy determination for selected emerging variants, based on ongoing trial amendment discussions with EMA; protocol amendment submitted to include secondary efficacy objective in ongoing phase IIa dose-confirmation trial in older adults in Peru and Panama; readouts from both trials expected in second quarter of 2021, potentially followed by MAA filing in same quarter 3/22/21
Edesa Biotech Inc., of Toronto EB-05 Monoclonal antibody targeting Toll-like receptor 4 Hospitalized COVID-19 with or at risk of developing acute respiratory distress syndrome Phase II/III study has enrolled more than 160 of the 316 patients who are expected to enroll in the phase II portion of the study 3/16/21
Immutep Ltd., of Sydney, and Merck & Co. Inc., of Kenilworth, N.J. Eftilagimod alpha + Keytruda (pembrolizumab) LAG-3 fusion protein + monoclonal antibody targeting PD-1 First-line head and neck squamous cell carcinoma Plans to run a 160-patient TACTI-003 study comparing the combination to Keytruda alone starting in mid-2021 3/16/21
Moderna Inc., of Cambridge, Mass. mRNA-1273 mRNA based vaccine COVID-19 prophylaxis First participant dosed in the phase II/III Kidcove study of children ages 6 months to less than 12 years 3/16/21
Neurorx Inc., of Radnor, Pa. Zyesami (inhaled aviptadil) VIP receptor agonist COVID-19 infection First participant dosed in phase II/III Avicovid-2 study in people with moderate and severe infection, aimed to prevent progression to respiratory failure 3/22/21
Reithera Srl, of Rome GRAd-COV2 Vaccine COVID-19 Started Covitar phase II/III study to test safety, immunogenicity and efficacy vs. placebo for the prevention of COVID-19 in adults 18 and older; the first part will be a phase II to confirm safety and immunogenicity and select the regimen for phase III 3/18/21
Sanford Burnham Prebys Medical Discovery Institute, of La Jolla, Calif., and the University of Hong Kong Clofazimine Binds guanine bases Severe COVID-19 Plans to start a study of the leprosy drug as soon as possible 3/16/21

Phase III

Astrazeneca plc, of Cambridge, U.K. AZD-1222 COVID-19 spike glycoprotein modulator COVID-19 infection U.S. vaccine trial showed statistically significant efficacy of 79% at preventing symptomatic infection and 100% at preventing severe disease and hospitalization, based on interim analysis of 32,449 participants who accrued 141 symptomatic cases; primary analysis will be submitted to FDA for EUA 3/22/21
Incyte Corp., of Wilmington, Del. Jakafi (ruxolitinib) JAK1/JAK2 inhibitor COVID-19-associated acute respiratory distress syndrome In the Devent study, overall survival through day 29 was 55.2% for Jakafi compared to 74.3% for placebo (p=0.0280) in the 5-mg arm and 51.8% for Jakafi compared to 69.6% for placebo (p=0.0292) in the 15-mg arm 3/19/21
Medicago Inc., of Quebec City, and Glaxosmithkline plc, of London CoVLP (SARS-CoV-2 vaccine) Virus like particle-based vaccine COVID-19 infection Plant-derived vaccine candidate in combination with GSK's pandemic adjuvant advanced into 2-way crossover phase III portion of ongoing phase II/III study, expected to enroll up to 30,000 participants, initially including healthy adults ages 18 to 65 followed by adults >65 years 3/16/21
Merck & Co. Inc., of Kenilworth, N.J., and Eisai Co., Ltd., of Tokyo Lenvima (lenvatinib) and Keytruda (pembrolizumab) Receptor tyrosine kinase inhibitor and monoclonal antibody targeting PD-1 Advanced, metastatic or recurrent endometrial cancer following 1 prior platinum-based regimen  In Study 309/Keynote-775, the combination reduced the risk of disease progression or death by 44% (p<0.0001), with a median progression-free survival of 7.2 months compared to 3.8 months for chemotherapy; overall survival for the combination was 18.3 months compared to 11.4 months for chemotherapy (p<0.0001) 3/19/21

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.