Company Product Description Indication Status
Phase I
Autifony Therapeutics Ltd., of Stevenage, U.K. AUT0-0201 Kv3 modulator  Schizophrenia; hearing disorders Single and multiple ascending-dose trial underway in U.K. in healthy volunteers suspended temporarily due to COVID-19 pandemic
Diamyd Medical AB, of Stockholm Remygen (GABA + antigen-based therapy) GABA receptor agonist Insulin-dependent diabetes Safety and dose-escalation portion of phase I/II Regenerate-1 trial in 6 individuals with long-term disease showed blood sugar control improved over 9-day treatment period and suggested protective effect during hypoglycemia
Targovax ASA, of Oslo, Norway ONCOS-102 GM-CSF receptor agonist Mesothelioma Participants (n=31) in phase I/II trial adding study drug to standard-of-care chemotherapy (pemetrexed/cisplatin) in first-, second- and later-line disease completed 9-month follow-up; median progression-free survival (PFS) remains in line with previously published data and compares favorably with historical control; updated PFS data, complemented by biomarker analyses, suggested enhanced immune activation and modulation of tumor microenvironment vs. control group
Phase II
AC Immune SA, of Lausanne, Switzerland Crenezumab Antibody targeting beta-amyloid Alzheimer’s disease Disclosed in first-quarter 2020 earnings that dosing in Colombian Alzheimer’s disease prevention study has been temporarily interrupted by countrywide stay-at-home order due to COVID-19; company continues to expect data from study in 2022
Allakos Inc., of Redwood City, Calif. Antolimab (AK-002) Sialic acid-binding Ig-like lectin 8 inhibitor Eosinophilic gastritis; eosinophilic duodenitis Interim results from open-label extension of Enigma study that enrolled 58 of 59 eligible participants showed 35 completed at least 52 weeks of treatment, 12 discontinued prior to 52 weeks and 11 remained active at < 52 weeks; sustained eosinophil depletion seen in blood and tissue, including rapid decline of blood eosinophil levels by week 4 and continued suppression through week 52; histologic remission achieved in 94% (45/48), and participants achieved 68% mean decrease in total symptom score at weeks 51-52
Antibe Therapeutics Inc., of Toronto ATB-346 (naproxen derivative) Cyclooxygenase 1/2 inhibitor Osteoarthritis CRO Veristat completed trial that enrolled 360 participants but ongoing restrictions due to COVID-19 pandemic slowing data analysis; top-line data from still-blinded trial now expected within 6 weeks
Athersys Inc., of Cleveland Multistem Stem cell therapy Non-ST elevation acute myocardial infarction Study terminated
Glaxosmithkline plc, of London Daprodustat HIF-PH inhibitor Anemia in chronic kidney disease Recruitment in study comparing effect of drug to darbepoetin alfa on endothelial function by assessing forearm blood flow temporarily paused due to COVID-19
Leo Pharma A/S, of Ballerup, Denmark Delgocitinib cream Pan-JAK inhibitor Discoid lupus erythematosus Trial put on hold due to COVID-19
Novartis AG, of Basel, Switzerland BAF-312 (siponimod) Sphingosine 1-phosphate receptor modulator Intracerebral hemorrhage Recruitment temporarily paused due to COVID-19
Sound Pharmaceuticals Inc., of Seattle SPI-1005 (ebselen) Glutathione peroxidase stimulator Bipolar disorder In conjunction with University of Oxford (U.K.), phase IIa study that enrolled 60 adults with active mania or hypomania showed 11.8-point reduction in Young Mania Rating Scale scores for study drug vs. 7.2-point reduction for placebo (p<0.058); study drug produced 1.4-point reduction in CGI-S scores vs. 0.7-point reduction for placebo (p<0.040); improvements in depressive scale scores also seen for study drug vs. placebo following 21 days of treatment
Viriom Inc., of San Diego VM-1500A Non-nucleoside reverse transcriptase inhibitor
HIV-1 infection
Phase IIa study initiated to assess intramuscular long-acting injectable nanoformulation of drug
Phase III
Aridis Pharmaceuticals Inc., of San Diego AR-301 (tosatoxumab) Human IgG monoclonal antibodies Staphylococcus aureus-induced pneumonia First participant with COVID-19 infection enrolled in ongoing trial assessing study drug's ability to mitigate secondary S. aureus bacterial pneumonia in individuals on mechanical ventilators
Cel-Sci Corp., of Vienna, Va. Multikine (leukocyte interleukin) CD4 agonist; IL-2 receptor agonist; unspecified cytokine receptor agonist Head and neck cancer Database from pivotal trial being prepared for lock after threshold of 298 deaths reached for data evaluation
Krystal Biotech Inc., of Pittsburgh, Pa. Bercolagene telserpavec  (B-VEC) COL7A1 gene stimulator Epidermolysis bullosa dystrophica Pivotal trial expected to begin in second half of 2020
Lupin Pharmaceuticals Inc., unit of Lupin Ltd., of Mumbai Solosec (secnidazole) 5-nitroimidazole antibiotic Trichomoniasis Pivotal trial showed statistically significant response rate, or microbiological cure, vs. placebo (p<0.001); sNDA filing to FDA expected in second half of 2020
Marinus Pharmaceuticals Inc., of Radnor, Pa. Ganaxolone GABAA receptor agonist Protocadherin 19 (PCDH19)-related epilepsy Ongoing Violet Study transitioning to proof-of-concept (POC) trial evaluating allopregnanolone sulfate as biomarker in enrolled participants with confirmed PCDH19 mutation; company limiting trial enrollment due to challenges to enroll global trial, including impact of COVID-19 pandemic, episodic nature of seizures in PCDH19 patients and potential commercial challenges; double-blind portion of POC trial expected to enroll about 15-20 participants, with results expected in first half of 2021
Newron Pharmaceuticals SpA, of Milan Sarizotan 5-HT 1a receptor agonist; dopamine D2 receptor agonist; dopamine D3/D4 receptor antagonist Rett syndrome Stars study failed to show efficacy on primary endpoint of percentage reduction in apnea episodes during waking time vs. placebo; company terminating program
Phase IV
Novo Nordisk A/S, of Bagsvaerd, Denmark Degludec Ultra-long-acting insulin Type 2 diabetes Recruitment in study comparing drug and glargine U100 for management of hospitalized and discharged patients suspended due to COVID-19
Novo Nordisk A/S, of Bagsvaerd, Denmark Liraglutide GLP-1 receptor agonist Type 2 diabetes Recruitment suspended in hospital discharge trial due to COVID-19

Notes

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

No Comments