Company Product Description Indication Status
Phase I
Caladrius Biosciences Inc., of Basking Ridge, N.J. CLBS-119 Autologous CD34+ cell therapy product COVID-19-induced lung damage Opened proof-of-concept study and begun screening patients; study will target patients who are experiencing hypoxia due to prior infection with SARS-CoV-2 and who require supplemental oxygen
Merck & Co. Inc., of Kenilworth, N.J. MK-8507  Non-nucleoside reverse transcriptase inhibitor HIV-1 infection Antiviral potency and pharmacokinetics of the once-weekly treatment support further investigation as part of a combination antiretroviral therapy
Moderna Inc., of Cambridge, Mass. mRNA-1345 mRNA vaccine Respiratory syncytial virus Started initial dosing in adults, to be followed by age de-escalation into children
Napajen Pharma Inc., of Burlingame, Calif., and Tokyo NJA-730 Combines anti-CD-40 oligonucleotide with beta-glucan delivery technology Prevention of acute graft-vs.-host disease Data showed drug well-tolerated in healthy subjects up to doses of 6 mg; phase II study expected to start in 2021
Noxopharm Ltd., of Sydney Veyonda (idronoxil) Topoisomerase inhibitor COVID-19 Treated first patient in Noxcovid-1 study enrolling subjects hospitalized with moderate lung dysfunction requiring low oxygen support who are at risk of progressing rapidly into requiring intensive care and mechanical ventilation
Ocular Therapeutix Inc., of Bedford, Mass. OTX-CSI (cyclosporine intracanalicular insert) Calcineurin inhibitor Dry eye disease Top-line results showed tear production as measured by the Schirmer’s test improved from mean values of 4.2 mm at baseline to 8.2 mm at week 12; 1 in 5 (20%) subjects had a ≥ 10 mm increase in Schirmer’s vs. baseline; improvement in signs of DED as measured by corneal total fluorescein staining (a mean value of 6.7 at baseline, improved to a mean value of 2.7 at week 12, on a scale of 0 to 15) and an improvement in symptoms of DED as measured by the visual analogue scale (VAS) eye dryness severity score (a mean value of 51 at baseline, improved to a mean value of 33 at week 12, on a scale of 0 to 100) and the VAS dry eye frequency score (a mean value of 51 at baseline, improved to a mean value of 31 at week 12, on a scale of 0 to 100)
Philogen SpA, of Siena, Italy Onkekafusp alpha (L19-TNF) TNF alpha ligand; fibronectin modulator High-grade glioma Initial results of first patients in phase I/II trial showed monotherapy induced not only a selective tumor necrosis in all patients (evidenced by contrast-enhanced and perfusion MRI), but also provided cases of prolonged disease stabilization; data published in Science Translational Medicine
Phase II
Cassiopea SpA, of Lainate, Italy Clascoterone  Androgen receptor inhibitor Androgenetic alopecia Completed enrollment of 293 women in the study comparing 2 dose levels of clascoterone to minoxidil and to vehicle; top-line data expected in the second quarter of 2021
Merck & Co. Inc., of Kenilworth, N.J. Islatravir Nucleoside reverse transcriptase translocation inhibitor Treatment-naïve HIV-1 infection At week 96, Islatravir plus Pifeltro (doravirine) maintained virologic suppression (HIV-1 RNA levels <50 copies/mL) similar to Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
Phase III
Allergan plc, of Dublin Relamorelin Ghrelin agonist Diabetic gastroparesis Studies terminated; relamorelin program terminated due to business decisions
Amgen Inc. of Thousands Oaks, Calif., Cytokinetics Inc., of South San Francisco, and Servier Laboratories, of Suresnes, France Omecamtiv mecarbil Cardiac myosin activator Heart failure with reduced ejection fraction In the Galactic-HF study, drug reduced the composite endpoint of reduction of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo (p=0.0252); no reduction in CV death was observed
Daiichi Sankyo Europe GmbH, of Munich, Germany Nilemdo (bempedoic acid) Inhibits ATP citrate lyase Heterozygous familial hypercholesterolaemia Pooled data from 2 studies of 3,000+ patients showed bempedoic acid reduced low-density lipoprotein cholesterol by 22.3% compared to placebo in people  who were taking their maximally tolerated statin
Impel Neuropharma Inc., of Seattle INP-104 Nasally delivered dihydroergotamine mesylate Migraine  Within 2 hours of receiving their first dose of INP-104, 38% of patients reported freedom from migraine pain, 52% had freedom from their most bothersome migraine symptom and 66.3% experienced pain relief 
Jazz Pharmaceuticals plc, of Dublin Xywav (calcium, magnesium, potassium, and sodium oxybates) GABA B receptor agonist Idiopathic hypersomnia In the randomized withdrawal portion of the 115-patient study, patients administered placebo had worse scores compared with Xywav for Epworth Sleepiness Scale (p<0.0001), Patient Global Impression of Change (p<0.0001) and Idiopathic Hypersomnia Severity Scale (p <0.0001)
Pfizer Inc., of New York, and Opko Health Inc., of Miami Somatrogon  Growth hormone plus 1 copy of C-terminal peptide from beta chain of human chorionic hCG at the N-terminus and 2 copies at the C-terminus. Growth hormone deficiency Mean overall Life Interference total score after 12 weeks of treatment with somatrogon once-weekly was 8.63 compared to 24.13 for treatment with somatropin once-daily (p<0.0001)
Viiv Healthcare Ltd., of London Dovato (dolutegravir/lamivudine) 2-drug antiviral regimen HIV-1 96-week data from Tango study continued to demonstrate noninferior efficacy compared to continuation of tenofovir alafenamide fumarate (TAF)-based regimen of at least 3 drugs in virologically suppressed adults who have not previously experienced virologic failure; no participants on Dovato (0/369, 0%) and 3 (3/372, <1%) on TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure

Notes

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