Company Product Description Indication Status
Phase I
Alligator Bioscience AB, of Lund, Sweden ATOR-1017  Activates 4-1BB receptors  Metastasized cancer Adverse events were mild or moderate; data review committee cleared the 40-mg dose and approved the start of dosing with 100 mg
Onxeo S.A., of Paris AsiDNA DDR inhibitor Advanced solid tumors A dose of 600 mg was determined to be optimal for use in combination with chemotherapies (DRIIV-1b study) and a PARP inhibitor (REVOCAN study)
Phase II
Applied Molecular Transport Inc., of South San Francisco AMT-101 GI-selective, oral fusion of rhIL-10 Moderate to severely active ulcerative colitis First of approximately 100 patients treated in the study; primary endpoint is Mayo Score at week 12; secondary endpoints include safety, pharmacokinetics, health-related quality of life and markers of disease activity as measured by symptoms, endoscopy, histology and biomarkers
Axcella Health Inc., of Cambridge, Mass.  AXA-1125 + AXA-1957 Endogenous metabolic modulators Nonalcoholic fatty liver disease In the AXA1125-003 study, AXA-1125 achieved numerically greater reductions from baseline in biomarkers of liver fat and fibroinflammation compared to placebo; AXA-1957 showed activity in a number of key biomarkers, but with less consistent directional change than AXA-1125
Cognition Therapeutics Inc., of Pittsburgh CT-1812 Binds to a receptor on neurons that regulates cellular damage response pathways Mild to moderate Alzheimer’s disease First patient treated in the Sequel study; primary outcome of the study is quantitative EEG; also last patient enrolled and treated in the second cohort of the Shine study
Cymabay Therapeutics Inc., of Newark, Calif. Seladelpar  PPAR-delta agonist Primary biliary cholangitis At 1 year, the mean decreases in alkaline phosphatase (ALP) were 41% and 45% in patients treated with 5 mg with the option to increase to 10 mg and with 10 mg only, respectively; composite responder rate measured at 1 year, defined as a patient with ALP <1.67 x ULN, ≥ 15% decrease in ALP and total bilirubin ≤ULN, was 55% and 69% in the 5/10-mg and 10-mg groups, respectively
Durect Corp., of Cupertino, Calif. DUR-928  Liver X receptor antagonist Alcoholic hepatitis Drug exposure for DUR-928 (as measured by both AUC and Cmax) was dose proportional and comparable between moderate and severe patients; Cmax was 2-fold higher in patients compared to healthy individuals due to liver injury
Mycovia Pharmaceuticals Inc., of Durham, N.C. Oteseconazole (VT-1161) Antifungal Acute vulvovaginal candidiasis Data published in Clinical Infectious Diseases showed 79.3% of women in the combined oteseconazole groups achieved therapeutic cure compared with 62.5% of those treated with fluconazole; at 3 and 6 months, 28.5% and 46.1% of women treated with fluconazole, respectively, had mycological recurrence compared to no women treated with oteseconazole
Oncosec Medical Inc., of Pennington, N.J. Tavo Interleukin-12 plasmid Operable locally/regionally advanced melanoma Started investigator-sponsored study testing Tavo plus Opdivo (nivolumab, Bristol Myers Squibb Co.)
Redhill Biopharma Ltd., of Tel Aviv, Israel Opaganib (Yeliva, ABC-294640) Sphingosine kinase-2 inhibitor Severe COVID-19 pneumonia After reviewing safety data from the first 12 patients, the safety monitoring committee recommended continuing the study without change
Urogen Pharma Ltd., of Princeton, N.J., and Abbvie Inc., of North Chicago RTGel hydrogel + Botox Sustained release, hydrogel + onabotulinumtoxinA Overactive bladder The Apollo study didn't meet the primary endpoint of reduction in urinary incontinence episodes per day; data suggests Botox wasn't able to effectively permeate the urothelium
Phase III
Intercept Pharmaceuticals Inc., of New York Obeticholic acid (OCA) FXR agonist  Nonalcoholic steatohepatitis New analysis from patients in the Regenerate study with 24-month data showed mean values of transaminases and other serum-based tests improved rapidly in patients treated with OCA and were sustained beyond 18 months of therapy compared with placebo; liver stiffness in patients treated with OCA vs. placebo after 24 months of therapy, with a mean difference of 2.7 kPa between OCA 25 mg and placebo

Notes

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