Company Product Description Indication Status
Phase I
Catalyst Biosciences Inc., of South San Francisco Marzaa (marzeptacog alfa, activated) Factor VIIa agonist Bleeding disorder Findings from pharmacokinetic/pharmacodynamic study supported subcutaneous dosing regimen for planned phase III registrational trial in individuals with hemophilia A or B with inhibitors
Orpheris Inc., subsidiary of Ashvattha Therapeutics LLC, of Redwood City, Calif. OP-101 Dendrimer-based acetylcysteine therapy COVID-19 infection In single subcutaneous dose study, OP-101 (4 or 8 mg/kg) in healthy volunteers was well-tolerated with only mild transient injection site reactions and no other adverse events, supporting use of maximum planned I.V. dose (8 mg/kg) in phase II study in individuals with severe infection
Tychan Pte Ltd., of Singapore TY-027 (bifunctional peptide derivative) NK1 receptor antagonist; opioid receptor delta/mu agonist COVID-19 infection 6-week trial set to begin through Singhealth Investigational Medicine Unit; efficacy data expected in third quarter of 2020
Phase II
Abbvie Inc., of North Chicago ABBV-3373 Antitumor necrosis factor glucocorticoid receptor modulator  Rheumatoid arthritis Phase IIa study in adults with moderate to severe disease showed greater difference in primary endpoint change in DAS28-CRP from baseline to week 12 for study drug (-2.65) vs. prespecified historical adalimumab mean (-2.13) (p=0.022); evaluations of serum cortisol levels over 12 weeks indicated no systemic glucocorticoid effects
Biondvax Pharmaceuticals Ltd., of Jerusalem Multimeric-001 (M-001) Non-flagellin-based, single-protein vaccine Influenza infection NIH clinical study report concluded that trial in 120 adult volunteers met primary objectives of safety and T-cell immune responses 
Dermata Therapeutics LLC, of San Diego DMT-310 Freshwater sponge-based natural product  Moderate to severe acne vulgaris At week 12, DMT-310 achieved Investigator Global Assessment success (at least a 2-point reduction and a score of 0 or 1) in 44.4% of patients vs. 17.8% of placebo patients (p=0.0003); mean change from baseline in inflammatory lesion count was -15.6 for drug and -10.8 for placebo (p=0.0017); mean change from baseline in non-inflammatory lesion count was -18.3 for drug and -12.4 for placebo (p=0.0027)
Devonian Health Group Inc., of Quebec City Thykamine Interleukin-1 beta/TNF-alpha ligand modulator Mild to moderate atopic dermatitis Completed enrollment in study; top-line results expected in November 2020
Opthea Ltd., of Melbourne, Australia OPT-302 Vascular endothelial growth factor receptor 3 trap Treatment-refractory persistent diabetic macula edema OPT-302 plus Eylea (aflibercept) improved Best Corrected Visual Acuity by 5 letters or more in 52% of patients, compared to 60% of patients receiving Eylea alone; 26.7% of patients taking the combination gained 10 letters or more compared to 22.5% for Eylea; 12% of patients taking the combination gained 15 letters or more compared to 7.5% for Eylea; 2.7% of patients taking the combination lost 5 letters or more compared to 5% for Eylea
Pulmatrix Inc., of Lexington, Mass. PUR-1900 Inhaled formulation of antifungal itraconazole Allergic bronchopulmonary aspergillosis Study suspended due to COVID-19 pandemic
Phase III
Impel Neuropharma Inc., of Seattle INP-104 (dihydroergotamine mesylate) Intranasal formulation of ergot alkaloid  Acute migraine Results showed pivotal Stop 301 study met primary objectives, with no new safety signals following delivery of DHE to upper nasal space; exploratory efficacy data observed 66.3% of patients achieved pain relief and 38% achieved pain freedom at 2 hours following first dose; in the primary safety set (n=185), 33.1% of patients who took an average of 2 or more treatments per the 28-day period during the 24-week treatment phase, achieved pain freedom at 2 hours; initial onset of pain relief began as early as 15 minutes for 16.3% of patients, which continued to improve over time; sustained pain freedom was observed in majority of patients, with 98.4% and 95% reporting no recurrence of migraine or use of rescue medications during the 24- and 48-hour periods after using INP-104 during weeks 21-24
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab)  Monoclonal antibody targeting PD-1 First-line advanced or metastatic urothelial carcinoma Keytruda plus chemotherapy didn't improve progression-free survival or overall survival compared to chemotherapy alone by a statistically significant margin
Pfizer Inc., of New York Abrocitinib Janus kinase 1 inhibitor Moderate to severe atopic dermatitis Jade Teen study met the co-primary endpoints of proportion of patients achieving an Investigator's Global Assessment 0 or 1 and a 2-point or greater reduction from baseline at week 12 and the proportion of patients who achieved at least a 75% or greater change from baseline in their Eczema Area and Severity Index EASI score at week 12; data will be presented at a future scientific meeting

Notes

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

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