Company Product Description Indication Status
Phase I
9 Meters Biopharma Inc., of Raleigh, N.C. NM-002 Long-acting injectable GLP-1 agonist Short bowel syndrome Started phase Ib/IIa trial; top-line results expected in first half of 2021
Aiviva Biopharma Inc., of Newport Beach, Calif. AIV-001 Multikinase inhibitor formulated for prolonged drug release via intradermal treatment Dermal scarring Completed phase I/IIa study in subjects undergoing abdominoplasty, with results showing drug was well-tolerated, with pharmacokinetics analysis showing prolonged drug residence around treated incisional wound with very low systemic exposure detected; reduction in fibrosis within 7-10 days post wounding
Kiadis Pharma NV, of Amsterdam, the Netherlands K-NK003 Natural killer (NK) cell therapy Acute myeloid leukemia First of up to 56 adults with relapsed/refractory disease enrolled and treated in off-the-shelf NK cell therapy consisting of 6 doses of 1 x 107 cells/kg to 1 x 108 cells/kg following reinduction chemotherapy; goal is to establish safety and determine optimal dosing and overall response rate
Neoimmunetech Inc., of Rockville, Md. NT-17 (efineptakin alfa) Long-acting human IL-7 Relapsed/refractory advanced solid tumors Dosed first patient in phase Ib/IIa trial in combination with Keytruda (pembrolizumab, Merck & Co. Inc.)
Noxopharm Ltd., of Sydney Veyonda Blocks cGAS-STING signaling COVID-19 Started its Noxcovid clinical program with a study in Europe testing Veyonda as potential treatment of cytokine storm and septic shock resulting from COVID-19
Phase II
Acceleron Pharma Inc., of Cambridge, Mass. Sotatercept Ligand trap for members of the TGF-beta superfamily Pulmonary arterial hypertension Top-line results from Pulsar trial showed patients on stable background PAH-specific therapies treated with sotatercept experienced statistically significant reduction in pulmonary vascular resistance (PVR), the trial’s primary endpoint, at week 24 vs. placebo
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist COVID-19 Received ethics approval for U.S. study sites for phase IIb/III study
Assembly Biosciences Inc., of South San Francisco ABI-H2158 Second-generation core inhibitor Chronic hepatitis B infection Started study testing combination with entecavir vs. placebo with entecavir in treatment-naïve patients with HBeAg-positive chronic hepatitis B infection without cirrhosis
Bergenbio ASA, of Bergen, Norway Bemcentinib Selective ALX kinase inhibitor Non-small-cell lung cancer Data from cohort B, stage 1 of the trial testing combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with confirmed progression on prior immune checkpoint therapy showed 7 of 12 scored positive in the composite-AXL immunohistochemistry biomarker (c-AXL), and 6 of those 7 reported clinical benefit, including one partial response and one unconfirmed partial response, with 2.5-fold improvement in median progression-free survival; overall survival (OS) update from cohort A showed cAXL-positive patients reported OS of 79% and median OS of 17.3 months vs. 60% and 12.4 months, respectively, for cAXL-negative patients
Geneuro SA, of Geneva Temelimab Monoclonal antibody targeting pathogenic retroviral envelope protein pHERV-W Env Multiple sclerosis First patient included in study at Karolinska Institutet’s Academic Specialist Center in Stockholm; 1-year study to enroll 40 patients whose disability progresses without relapses; despite delay due to COVID-19, results remain expected in second half of 2021
Insmed Inc., of Bridgewater, N.J. Brensocatib Dipeptidyl peptidase I inhibitor Noncystic fibrosis bronchiectasis Willow study met primary endpoint, with study drug prolonging time to first pulmonary exacerbation over 24-week treatment vs. placebo (p=0.027 for 10 mg; p=0.044 for 25 mg); risk of exacerbation at any time during trial vs. placebo was reduced by 42% for 10-mg group (p=0.029) and by 38% for 25 mg group (p=0.046); at 10 mg, study drug resulted in 36% reduction in rate of pulmonary exacerbations vs. placebo, a key secondary endpoint (p=0.041)
Oncolytics Biotech Inc., of San Diego Pelareorep Oncolytic retrovirus therapy Breast cancer Investigator-sponsored single-arm Irene study will assess pelareorep in combination with anti-PD-1 retifanlimab (Incyte Corp.) in 25 individuals with unresectable locally advanced or metastatic triple-negative disease; co-primary endpoints are safety and objective response rate; secondary endpoints include progression-free survival, overall survival and duration of response
Theravance Biopharma Inc., of Dublin TD-0903 JAK inhibitor Acute lung injury First participant hospitalized with ALI caused by COVID-19 infection dosed in 2-part study; first part will assess safety, tolerability and response to treatment in ascending-dose cohorts, with each patient dosed for 7 days; second part will expand to hospital-based sites in U.K. and other European countries and in U.S.
Phase III
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 (repurposed ondansetron) 5-HT 3 receptor antagonist Alcohol use disorder Recruitment initiated in Poland in pivotal Onward trial targeting participants with certain genotypes related to serotonin transporter and receptor genes; additional sites expected to open during third quarter of 2020
Astrazeneca plc, of Cambridge, U.K. PT-010 (budesonide + glycopyrronium + formoterol fumarate) Beta 2 adrenoceptor agonist; muscarinic receptor antagonist Chronic obstructive pulmonary disease In Ethos trial, triple-combination therapy achieved 24% reduction (p<0.001) in rate of moderate or severe exacerbations vs. glycopyrronium + formoterol fumarate and 13% reduction (p=0.003) vs. PT-009 (budesonide + formoterol fumarate) in those with moderate to very severe disease; in key secondary endpoint, PT-010 showed 46% reduction in risk of all-cause mortality vs. glycopyrronium + formoterol fumarate (unadjusted p=0.01); findings published in The New England Journal of Medicine
Moberg Pharma AB, of Stockholm MOB-015 (topical terbinafine) Squalene epoxidase inhibitor Onychomycosis European study that enrolled 452 participants met primary endpoint, showing noninferiority vs. topical ciclopirox in complete cure of target toenail at 52 weeks (1.8% vs. 1.6%, respectively), with mycological cure achieved in 84% vs. 42%, respectively
Novan Inc., of Morrisville, N.C. SB-206 (berdazimer sodium topical gel) Nitricil nitric oxide-releasing polymer Molluscum contagiosum infection Additional pivotal B-Simple4 trial expected to enroll first participant in September 2020, with top-line efficacy results targeted for late second quarter 2021

Notes

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

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