Company Product Description Indication Status
Phase I
Clover Biopharmaceuticals Inc., of Perth, Australia, and Chengdu, China SCB-2019 COVID-19 S-Trimer subunit vaccine candidate COVID-19 Initiated trial testing combination with Glaxosmithkline plc’s pandemic adjuvant system and Dynavax Corp.’s CpG 1018 adjuvant; preliminary data expected in August 2020
Cohbar Inc., of Menlo Park, Calif. CB4-211 Mitochondria-based therapeutic Nonalcoholic fatty liver disease Study in healthy non-obese subjects and subjects with NAFLD suspended due to COVID-19
Cyclerion Therapeutics Inc., of Cambridge, Mass. IW-6463 CNS-penetrant soluble guanylate cyclase stimulator Neurodegenerative disease Study in healthy elderly participants terminated; some subjects could not complete second crossover period due to COVID-19-related site closure; study closed to allow analysis of all collected data
Nkmax America Inc., of Santa Ana, Calif. SNK-01 Autologous natural killer cell immunotherapy Plaque psoriasis Study withdrawn
Novo Nordisk A/S, of Bagsvaerd, Denmark AM-833 Once-weekly subcutaneous amylin analogue Obesity 20-week combination trial with once-weekly subcutaneous semaglutide 2.4 mg showed patients receiving highest dose lost an average of 17.1% body weight from a mean baseline body weight of 95.1 kg (secondary endpoint)
Uniqure NV, of Amsterdam AMT-130 Gene therapy Huntington disease Treated first 2 patients in phase I/II trial 
Phase II
Aurinia Pharmaceuticals Inc., of Victoria, British Columbia Voclosporin Calcineurin inhibitor; IL-2 receptor antagonist Focal segmental glomerulosclerosis  Study terminated due to low recruitment rate
Azevan Pharmaceuticals Inc., of Bethlehem, Pa. SRX-246 Small-molecule vasopressin-1a receptor antagonist Post traumatic stress disorder Study suspended due to COVID-19
Cymabay Therapeutics Inc., of Newark, Calif. Seladelpar Targets PPAR-delta Primary biliary cholangitis New pruritis and quality of life data from open-label study showed substantial improvement in pruritus (VAS ≥ 20-point decrease) at 1 year in patients with moderate to severe pruritus (VAS ≥ 40 at BL), seen in 58% and 93% in 5/10-mg and 10-mg groups, respectively; about half experienced baseline sleep disturbance due to itch as measured by the 5-D itch score and that improvement in sleep disturbance at 1 year was observed in 81% (5/10 mg) and 78% (10 mg) 
Finch Therapeutics Group Inc., of Somerville, Mass. CP-101 Oral microbiome drug Prevention of recurrent C. difficile infection Met primary endpoint in Prism trial, with 74.5% of recurrent CDI patients who received a single administration achieving sustained clinical cure through week 8, a statistically significant improvement vs. 61.5% of patients in control group who received standard-of-care antibiotic therapy alone (p<0.05)
Novartis AG, of Basel, Switzerland, and Amgen Inc., of Thousand Oaks, Calif. CAD-106 and CNP-520 Anti-amyloid immunotherapy and BACE inhibitor Alzheimer’s disease Phase II/III study in patients at risk for onset of clinical symptoms of AD terminated after planned review by data monitoring committee of unblinded data identified worsening in some measures of cognitive function
Novo Nordisk A/S, of Bagsvaerd, Denmark AM-833 Once-weekly subcutaneous amylin analogue Obesity Headline data showed 26-week trial in 706 people with obesity or who were overweight with at least 1 weight-related co-morbidity met primary endpoint, demonstrating weight loss of 10.8% at the 4.5-mg dose, compared to a weight loss of 3% with placebo, reaching statistical significance
Otsuka Pharmaceutical Co. Ltd., of Tokyo OPS-2071 Fluoroquinolone candidate Crohn’s disease Study in patients showing symptoms of active inflammation terminated due to decision of sponsor
Reistone Biopharma Co. Ltd., of Shanghai SHR-0302 Selective small-molecule JAK1 inhibitor Moderate and severe alopecia areata Dosed first patient in study running in China, the U.S. and Australia
Ridgeback Biotherapeutics Inc., of Miami EIDD-2801 Oral nucleoside analogue COVID-19 Launched 2 trials; Study 203 will enroll recently symptomatic, newly diagnosed patients in a home, or out of hospital, setting; Study 2004 will enroll hospitalized patients with COVID-19
Sanofi SA, of Paris Fitusiran Once-monthly, subcutaneous RNAi therapeutic Hemophilia A and B Long-term results from open-label extension study demonstrated sustained antithrombin lowering (a reduction of around 75% from baseline), resulting in median peak thrombin values at the lower end of the range observed in healthy volunteer participants; low overall median annualized bleed rate (ABR) of 0.84; median ABR in non-inhibitor subgroup was 1.01 vs. pre-study median of 2 for patients previously on prophylactic treatment and 12 for patients previously on demand; in inhibitor subgroup, median ABRs were 0.44 vs. pre-study median of 42; low overall spontaneous bleeds (overall median of 0.38), with median ABRs by subgroup of 0.33 (non-inhibitor) and 0.39 (inhibitors)
Phase III
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis Jardiance (empagliflozin) SGLT2 inhibitor Chronic heart failure with reduced ejection fraction or preserved ejection fraction Full results from Emperial-Reduced and Emperial-Preserved trials related to exercise ability and symptom improvement showed no significant difference in change from baseline to week 12 in exercise ability with Jardiance vs. placebo, as measured by 6-minute walk test; in Emperial-Reduced, median 6-minute walk test increased by 13.5 meters vs. 18 meters with placebo, and in Emperial-Preserved, the increase was 10 meters vs. 5 meters with placebo; mean improvement in total symptom score of the KCCQ from baseline to week 12 was 4.55 points higher for Jardiance vs. placebo
Genentech, of South San Francisco, a member of the Roche Group Ipatasertib Oral drug designed to bind to all 3 isoforms of AKT to block P13K/AKT signaling pathway Metastatic castration-resistant prostate cancer Ipatential150 study met co-primary endpoint of radiographic progression-free survival (rPFS) in patients whose tumors had PTEN loss; in combination with abiraterone and prednisone/prednisolone, treatment provided statistically significant reduction in risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo; the other co-primary endpoint of rPFS in overall study population was not met

Notes

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