Company Product Description Indication Status
Phase I
Akebia Therapeutics Inc., of Cambridge, Mass. Vadadustat Hypoxia-inducible factor prolyl hydroxylase inhibitor Acute respiratory distress syndrome in COVID-19 patients Started an investigator-sponsored trial in up to 300 patients comparing vadadustat to placebo for up to 14 days of treatment
Galera Therapeutics Inc., of Malvern, Pa. Avasopasem manganese (GC-4419) Superoxide dismutase mimetic Locally advanced pancreatic cancer Completed patient enrollment in study comparing drug plus stereotactic body radiation therapy (SBRT) to SBRT alone
Histogen Inc., of San Diego HST-001 Hair stimulating complex enriched for KGF, VEGF and follistatin Androgenic alopecia Completed patient enrollment in study; data expected in the fourth quarter of 2020
Inmune Bio Inc., of La Jolla, Calif. Xpro-1595 Targets soluble tumor necrosis factor Alzheimer’s disease In 6 patients treated with 0.3 mg/kg or 1 mg/kg of Xpro-1595 for 12 weeks, whole brain inflammation increased by 1.7% and decreased of 2.3%, respectively; inflammation increased by 5.1% in a natural history comparison cohort; there was a 40.6% reduction in neuroinflammation in the arcuate fasciculus in patients treated with Xpro-1595 compared to a 4.6% increase in the comparison cohort
Landos Biopharma, of Blacksburg, Va. NX-13 Targets the NLRX1 receptor Healthy volunteers (eventually inflammatory bowel disease) Treated first subject in the study testing the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of NX-13
Medicago, of Quebec City, Dynavax Technologies Corp., of Emeryville, Calif., and Glaxosmithkline plc, of London CoVLP, CpG 1018 and pandemic adjuvant Coronavirus virus-like particle vaccine and 2 adjuvants COVID-19 prophylaxis Started study testing 3 dose levels of the vaccine alone or combined with 1 of 2 adjuvants in 180 healthy subjects
NMD Pharma A/S., of Aarhus, Denmark NMD-670 Chloride ion channel-1 inhibitor Myasthenia gravis Received approval from the Dutch ethics committee and regulatory authorities to start the study testing the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of NMD-670
Rigel Pharmaceuticals Inc., of South San Francisco Tavalisse (fostamatinib) Spleen tyrosine kinase inhibitor COVID-19 pneumonia Started an investigator-sponsored trial comparing Tavalisse to Jakavi (ruxolitinib, Incyte Corp.) and standard of care for 14 days; primary endpoint is the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia
Sotio, of Prague, Czech Republic SO-C101 Superagonist fusion protein of interleukin-15 Advanced/metastatic solid tumors Started part B of the study testing SO-C101 in combination with the PD-1 inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.)
Phase III
Albireo Pharma Inc., of Boston Odevixibat Ileal bile acid transporter inhibitor Biliary atresia Enrolled first patient in the Bold study testing the drug for 24 months; primary efficacy endpoint is improvement in the proportion of patients who are alive and have not undergone a liver transplant after 2 years of treatment compared to placebo; secondary outcome measures include time to onset of any sentinel events, total bilirubin levels and serum bile acid levels
Bioarctic AB, of Stockholm, Eisai Co. Ltd., of Tokyo, and Biogen Inc., of Cambridge, Mass. BAN-2401 Anti-amyloid beta protofibril antibody Asymptomatic Alzheimer's disease Started the Ahead 3-45 studies of 1,400 patients enrolled in 2 studies; A3 study will enroll patients with intermediate amount of amyloid in the brain; A45 will enroll participants with elevated levels of amyloid beta in the brain

Notes

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

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