Company Product Description Indication Status
Phase I
Kezar Life Sciences Inc., of South San Francisco KZR-616 Immunoproteasome inhibitor Systemic lupus erythematosus and lupus nephritis Patients with increased DNA antibodies (serologic markers of SLE disease activity) at baseline that completed through week 25 of the study showed decreased titers following treatment
Phase II
AKL Research and Development Ltd., of Stevenage, U.K. APPA Oral, fixed-dose combination of apocynin (4-hydroxy-3-methoxyacetophenone) and its isomer paeonol (2-hydroxy-4-methoxy-acetophenone) Osteoarthritis Recruited first patient
Direct Biologics LLC, of Austin, Texas Exoflo (extracellular vesicles) Extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells COVID-19 Launched a study testing Exoflo to treat COVID-19-associated acute respiratory distress syndrome
Oncologie Inc., of Waltham, Mass. Bavituximab Human-mouse chimeric monoclonal antibody against phosphatidylserine Gastric cancer Combined with Keytruda (pembrolizumab, Bristol Myers Squibb Co.), treatment demonstrated a 19% overall response rate (ORR) and 43% (3/7) ORR from an exploratory analysis in a biomarker-driven subgroup
Phase III
Achieve Life Sciences Inc., of Seattle Cytisinicline Plant-based alkaloid with high binding affinity to nicotinic acetylcholine receptor Smoking cessation Results showed that cytisinicline met the prespecified noninferiority to Chantix (varenicline, Pfizer Inc.) endpoint and was trending toward superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline, demonstrating a 4.29% improvement in quit rates in favor of cytisinicline
Astellas Pharma Inc., of Tokyo Padcev (enfortumab vedotin-ejfv) Nectin-4-targeting antibody-drug conjugate Urothelial cancer Met primary endpoint of overall survival compared to chemotherapy
Eli Lilly and Co., of Indianapolis Baricitinib JAK inhibitor COVID-19 In combination with remdesivir, met the primary endpoint of reduction of time to recovery in comparison with remdesivir alone
Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Advanced ovarian cancer 5-year follow-up data showed Lynparza reduced the risk of disease progression or death by 67%, and improved median progression-free survival to 56 months vs. 13.8 months for placebo
Merck KGaA, of Darmstadt, Germany Bavencio (avelumab) Fully human anti-PD-L1 immunoglobulin G1 monoclonal antibody Urothelial cancer Drug plus best supportive care (BSC) significantly extended overall survival compared with BSC alone in the 2 primary populations of all randomized patients and patients whose tumors were PD-L1+, and significantly more patients who received Bavencio as first-line maintenance were alive at 1 year
Roche Holding AG, of Basel, Switzerland Actemra (tocilizumab) IL-6 inhibitor COVID-19-associated pneumonia Patients who received drug plus standard of care (SOC) were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus SOC (p=0.0348)

Notes

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

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