Company Product Description Indication Status
Phase I
Aptorum Group Ltd., of New York ALS-4 Targets antimicrobial resistant properties of Staphylococcus aureus Infections First subject dosed
Equillium Inc., of La Jolla, Calif. Itolizumab Monoclonal antibody selectively targeting the CD6-ALCAM pathway Systemic lupus erythematosus Drug was safe and well-tolerated; demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells
Flexion Therapeutics Inc., of Burlington, Mass. FX-301 NaV1.7 inhibitor Post-operative pain First subject dosed
Kamada Ltd., of Rehovot, Israel Anti-SARS-CoV-2 plasma-derived hyperimmune globulin  Anti-SARS-CoV-2 plasma-derived hyperimmune globulin  COVID-19 Top-line results from phase I/II study showed 11 of 12 patients recovered following receipt of treatment; 7 were discharged from the hospital at or before day 5 post-treatment and the remaining 4 were discharged by day 9; following the infusion, anti-SARS CoV-2 IgG levels in the plasma of all patients increased; effect of the treatment on neutralization activity is being further analyzed, however, preliminary results demonstrated the IgG level increase was associated with enhanced neutralization activity
Nascent Biotech Inc., of San Diego Pritumumab Monoclonal antibody Brain cancer Initial dosing started 
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist COVID-19 Top-line data from phase IIb part of phase IIb/III trial showed, at day 15, there was 0% mortality in 20-mg dose vs. 3.3% mortality rate in untreated control arm (p=0.18); of patients with low blood oxygen level (SpO2 <94%), 100% in 20 mg-dose arm returned to normal levels of oxygen at day 4 vs. day 9 for patients in untreated arm (p=0.061); strong trend to less time spent in the ICU in the overall study (p=0.0315); power calculations for phase III projects 1,900 patients required for mortality endpoint or 450 patients required for blood oxygen level endpoint
Anavex Life Sciences Corp., of New York Anavex-2-73 (blarcamesine) Muscarinic M1 receptor modulator; opioid receptor sigma agonist 1 Alzheimer’s disease Independent data safety monitoring board for phase IIb/III trial completed preplanned review of interim safety data and recommended studies continue without modification 
Athersys Inc., of Cleveland, and Healios K.K., of Tokyo Multistem (invimestrocel) Cell therapy Acute respiratory distress syndrome caused by pneumonia Completed enrollment in One-Bridge study in Japan
Istari Oncology Inc., of Durham, N.C. Pvsripo  Immunotherapy; live-attenuated serotype 1 poliovirus vaccine  Melanoma First patient dosed in Luminos-102 study testing drug alone or in combination with PD-1/PD-L1 inhibitor in patients resistant to checkpoint therapies
Outlook Therapeutics Inc., of Monmouth Junction, N.J. ONS-5010/Lytenava (bevacizumab-vikg) Ophthalmic formulation of VEGF inhibitor Retinal diseases Results from Norse Three open-label safety study in patients for whom anti-VEGF therapy is an option showed no unexpected safety trends and had consistent profile with prior published data
Phase III
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 COVID-19 spike glycoprotein modulator COVID-19 Data from trial in adolescents, ages 12-15, with or without prior evidence of SARS-CoV-2 infection, demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants ages 16-25; vaccine was well-tolerated
Pharnext SA, of Paris PXT-3003 PMP22 gene inhibitor Charcot-Marie-Tooth disease type 1A First subject enrolled in Premier trial; primary efficacy endpoint will be the Overall Neuropathy Limitations Scale, which measures functional motor disability
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Eylea (aflibercept) VEGF inhibitor Moderate to severe nonproliferative diabetic retinopathy Initial results from NIH-sponsored study in patients with NPDR without center-involved diabetic macular edema (CI-DME) showed, at 2 years, a 68% reduced risk of developing vision-threatening complications (either proliferative diabetic retinopathy or CI-DME with vision loss) in patients who received Eylea in an every-16-weeks dosing regimen; in comparison, patients receiving sham injections were almost 5 times more likely to experience disease progression requiring Eylea rescue therapy; results published in JAMA Ophthalmology

Notes

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