Company Product Description Indication Status
Phase I
Aveo Oncology Inc., of Cambridge, Mass., and Biodesix Inc., of Boulder, Colo. Ficlatuzumab HGF inhibitory antibody Metastatic pancreatic ductal adenocarcinoma Results from phase Ib trial testing combination with nab-paclitaxel and gemcitabine in previously untreated disease showed 29% partial response rate and 92% rate of disease control; regimen was associated with significant hypoalbuminemia and edema, and follow-up safety study is under consideration testing ficlatuzumab in combination with an alternate cytotoxic regimen
Epygenix Therapeutics Inc., of Paramus, N.J. EPX-100 Modulates serotonin (5HT) signaling pathways Dravet syndrome Completed 2-period study in fasting healthy subjects and following a high-fat meal, showing drug to be safe and well-tolerated, with no clinically significant abnormalities among equal number of male and female subjects; phase II studies set to start in U.S. and Australia
Faron Pharmaceuticals Oy, of Turku, Finland Clevegen (bexmarilimab) Anti-Clever-1 antibody Ovarian cancer Ovarian cancer selected as second expansion cohort in ongoing part 2 portion of open-label phase I/II Matins trial assessing cancer immunotherapy targeting Clever-1-positive tumor-associated macrophages in metastatic or inoperable solid tumors
Innovation Pharmaceuticals Inc., of Wakefield, Mass. Delayed-release brilacidin tablets Host defense protein mimetic Inflammatory bowel disease Completed dosing in third and final cohort testing colonic delivery in healthy volunteers; top-line data expected shortly
Oric Pharmaceuticals Inc., of South San Francisco, and Astellas Pharma Inc., of Tokyo ORIC-101 and Xtandi (enzalutamide) Glucocorticoid receptor antagonist and androgen receptor antagonist Metastatic prostate cancer Dosed first patient in phase Ib trial testing combination in patients whose disease is progressing on enzalutamide
Sun Biopharma Inc., of Minneapolis SBP-101 Polyamine analogue designed to induce polyamine metabolic inhibition Pancreatic cancer Initial data showed combination with gemcitabine and nab-paclitaxel resulted in overall response rate of 62% at 2 highest dose cohorts, including 8 partial responses; disease control rate was 85% by RECIST criteria; 11 subjects in those cohorts (69%, n=16) saw maximum decrease in CA 19-9 of more than 60%; median duration of response, progression-free survival and overall survival not reached at time of data cutoff
Trovagene Inc., of San Diego Onvansertib PLK1 inhibitor KRAS-mutated metastatic colorectal cancer Data from ongoing phase Ib/II study in combination with FOLFIRI and Avastin (bevacizumab, Roche Holding AG) in second-line treatment show all 5 patients evaluable had significant reduction in KRAS mutation burden; 3 had a >25% tumor shrinkage and 1 patient is now eligible for curative surgery
Phase II
Anavex Life Sciences Corp., of New York ANAVEX2-73 (blarcamesine) Small-molecule activator of sigma-1 receptor Parkinson’s disease dementia Met enrollment target for study; top-line results expected by mid-2020
Daiichi Sankyo Co. Ltd., of Tokyo, and Astrazeneca plc, of Cambridge, U.K. DS-8201 (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki) ErbB2 tyrosine kinase receptor inhibitor Gastric cancer Pivotal Destiny-Gastric01 trial in HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that progressed following 2 or more treatment regimens, including trastuzumab and chemotherapy, met primary endpoint of statistically significant improvement in objective response rate vs. investigator’s choice of chemotherapy and showed statistically significant improvement in key secondary endpoint of overall survival
Deinove SA, of Paris DNV-3837 DNA gyrase inhibitor Clostridioides difficile infection First participant enrolled in 2-stage trial to evaluate efficacy, safety and pharmacokinetics in individuals with C. diff gastrointestinal infection; findings expected by year-end
Hansa Biopharma AB, of Lund, Sweden Imlifidase Cysteine protease stimulator; immunoglobulin G antagonist Goodpasture disease (anti-GBM antibody disease) Enrollment completed in investigator-initiated study in 15 participants with severe disease; top-line data expected in third quarter
Khondrion BV, of Nijmegen, the Netherlands Sonlicromanol (previously KH-176) Amide derivative of vitamin E analogue Trolox Mitochondrial diseases First participants dosed in phase IIb Khenergyze study enrolling those with genetically confirmed DNA mutation in mitochondrial transfer RNALeu, responsible for MELAS spectrum disorders; primary outcome is attention domain score of cognitive functioning as assessed by computerized Cogstate visual identification test, with results expected in second half of 2020
Oncoimmune Inc., of Rockville, Md. CD24-Fc Fusion protein Acute graft-vs.-host disease Data from phase IIa study testing prophylaxis for allogeneic hematopoietic stem cell transplantation with matched unrelated donors in treatment of leukemia and myelodysplastic syndrome showed adding CD24-Fc to tacrolimus and methotrexate was significantly better vs. placebo and historical controls in 180-day grade III-IV GVHD-free survival, the planned primary endpoint of upcoming phase III study
Phase III
Astrazeneca plc, of Cambridge, U.K. Brilinta (ticagrelor) P2Y12 receptor antagonist Acute ischemic stroke; transient ischemic attack Thales trial of study drug, dosed at 90 mg twice daily and taken with aspirin for 30 days, achieved statistically significant reduction in risk of primary composite endpoint of stroke and death compared to aspirin alone
Eli Lilly and Co., of Indianapolis, and Incyte Corp., of Wilmington, Del. Olumiant (baricitinib) Dual JAK1/JAK2 tyrosine kinase inhibitor Atopic dermatitis 4-mg dose in Breeze-Ad4 combination study with topical corticosteroids in moderate to severe disease not controlled with cyclosporine met primary endpoint of at least 75% improvement of skin inflammation from baseline measured by EASI score at week 16
Evolus Inc., of Newport Beach, Calif. PrabotulinumtoxinA Acetylcholine receptor antagonist Crow's feet lines Results of split-face, head-to-head study in which primary endpoint of noninferiority was achieved with responder rates of 65.02% for prabotulinumtoxinA vs. 62.56% for onabotulinumtoxinA at week 4 were published in Dermatologic Surgery
Nucana plc, of Edinburgh, U.K. Acelarin (NUC-1031) Nucleotide analogue Biliary tract cancer First patients dosed in study testing combination with cisplatin in first-line treatment; up to 828 patients will be enrolled; primary objectives are overall survival and objective response rate

Notes

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