Company Product Description Indication Status
Phase I
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat (AG-348) Pyruvate kinase stimulator Sickle cell disease 7 of 8 patients (88%) who completed all planned dose levels experienced Hb increase, with 5 (63%) achieving hemoglobin increase of ≥1 g/dL from baseline (range 1.0-2.7 g/dL); all 5 who achieved hemoglobin increase of ≥1 g/dL did so at doses of 50 mg BID or lower; treatment was associated with decreases in hemolytic markers such as bilirubin, lactic acid dehydrogenase and reticulocytes
Aura Biosciences Inc., of Cambridge, Mass. AU-011 Viral-like particle bioconjugates activated with ophthalmic laser Primary choroidal melanoma Updated phase Ib/II data show multiple administrations generally well-tolerated; tumor control and vision preservation data continue to be supportive of planned pivotal study
Eli Lilly and Co., of Indianapolis Merestinib (LY-2801653) Small-molecule MET inhibitor Breast cancer Terminated because enrollment incomplete at end of contracted enrollment period
Octimet Oncology NV, of Beerse, Belgium OMO-1 MET kinase inhibitor Solid malignancies Terminated for strategic reasons; no safety, efficacy issues
Phase II
Bone Therapeutics SA, of Gosselies, Belgium Allob Allogeneic cell therapy Failed lumbar fusion Study terminated
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist Nonalcoholic steatohepatitis  Initiated 90-patient trial
Noveome Biotherapeutics Inc., of Pittsburgh ST-266 Cell-free biologic made by culturing population of human amnion-derived cells Persistent corneal epithelial defects At data cutoff, 11 patients had been enrolled in the study and 10 completed treatment; all 10 eyes demonstrated response to treatment by day 28 with significantly decreased size (p=0.001); 3 eyes had complete healing during the 28-day treatment window
Pulmocide Ltd., of London PC-945 Inhaled triazole antifungal Aspergillus fumigatus lung infection in lung transplant Study terminated early due to COVID-19
Pulmocide Ltd., of London PC-945 Inhaled triazole antifungal Aspergillus fumigatus lung infection in cystic fibrosis Study terminated early due to COVID-19
Pulmocide Ltd., of London PC-945 Inhaled triazole antifungal Aspergillus or Candida lung infections in asthma or chronic respiratory disease Study terminated early due to COVID-19
Respivant Sciences Inc., of San Diego RVT-1601 Inhalation formulation of cromolyn sodium Persistent cough in idiopathic pulmonary fibrosis Terminated due to COVID-19
Phase III
Atox Bio Ltd., of Ness Ziona, Israel Reltecimod Peptide binding to CD28 co-stimulatory receptor Sepsis-associated acute kidney injury Study terminated due to very slow enrollment of target patient population
Novo Nordisk A/S, of Bagsvaerd, Denmark Semaglutide GLP-1 receptor agonist Obesity and type 2 diabetes Headline results showed 68-week Step 2 trial in 1,210 adults met both primary endpoints; statistically significant greater weight loss of 9.6% achieved with sc semaglutide 2.4 mg, from a mean baseline body weight of 99.8 kg, compared to placebo (3.4% weight loss) and sc semaglutide 1 mg (7% weight loss); 68.8% who received sc semaglutide 2.4 mg achieved weight loss of 5% or more after 68 weeks vs. 28.5% with placebo
Novo Nordisk A/S, of Bagsvaerd, Denmark Semaglutide GLP-1 receptor agonist Obesity Headline results showed 68-week Step 3 trial, testing drug as adjunct to intensive behavioral therapy met both primary endpoints; statistically significantly greater weight loss of 16% achieved with sc semaglutide 2.4 mg, from a mean baseline body weight of 105.8 kg, compared to a 5.7% weight loss in placebo group; 86.6% in sc semaglutide arm achieved weight loss of 5% or more vs. 47.6% in placebo arm
Otsuka Pharmaceutical Co. Ltd., of Tokyo Centanafadine Oral serotonin-norepinephrine-dopamine triple-reuptake inhibitor Attention deficit hyperactivity disorder Top-line results from 2 6-week trials showed statistically significant improvement vs. placebo on primary efficacy endpoint, change from baseline to day 42 on the adult ADHD investigator symptom rating scale (AISRS) total score (p<0.05 in the first study and p<0.01 in the second study); in both trials, statistically significant improvements vs. placebo also observed in key secondary efficacy outcome, Clinical Global Impression – Severity scale change from baseline to day 42 (p<0.05)
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin 0.7% topical solution) Blistering agent Molluscum contagiosum Pooled data from 2 analyses of Camp trials showed, regardless of lesion count, all VP-102 quartiles had statistically significantly higher percentage of patients with complete clearance of all baseline and new lesions as compared to vehicle (p<0.05), and that complete clearance rates were similar across all VP-102 quartiles

Notes

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