Company Product Description Indication Status
Phase I
Axcella Health Inc., of Cambridge, Mass. AXA-1665 Composition of naturally occurring amino acids Mild and moderate hepatic insufficiency At the highest dose, psychometric hepatic encephalopathy score improved compared to placebo (p<0.05); baseline in Fischer Ratio increased by 21% for low dose and 44% for high dose; fasted plasma ammonia levels remained stable in treated patients 
Biontech SE, of Mainz, Germany, and Shanghai Fosun Pharmaceutical Co. Ltd., of Shanghai BNT-162b1  mRNA vaccine COVID-19 prophylaxis Dosed first 72 of 144 participants in the Chinese study testing 2 dose levels of the vaccine compared to placebo
Emmaus Life Sciences Inc., of Torrance, Calif. L-glutamine oral powder Pharmaceutical grade L-glutamine Diverticulosis After 6 months of a scheduled 12-month treatment, 2 patients had a 50% and 100% decline in the number of diverticula in the sigmoid colon, respectively
Modag GmbH, of Wendelsheim, Germany Anle-138b Binds oligomeric structures of alpha-synuclein  Healthy volunteers (eventually Parkinsonian disorders) At doses up to 300 mg daily, drug had excellent safety and tolerability profiles and reached significantly higher plasma levels in humans than those required for full therapeutic efficacy in animal models
Novavax Inc., of Gaithersburg, Md. NVX‑CoV2373 Protein-based nanoparticle vaccine  COVID-19 prophylaxis Vaccine produced neutralizing antibodies in 100% of the 131 participants; 5-ug dose plus Matrix-M adjuvant was comparable to 25-ug dose
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) N-methyl-D-aspartate receptor antagonist Idiopathic pulmonary fibrosis and chronic cough Treated first patient in study
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) N-methyl-D-aspartate receptor antagonist COVID-19 Enrolled first patient in multinational phase IIb/III study to determine whether drug can reduce severity and duration of COVID-19 infection
Clovis Oncology Inc., of Boulder, Colo. Lucitanib Angiogenesis inhibitor Gynecologic cancer Treated first patient in the LIO-1 study testing lucitanib plus Opdivo (nivolumab, Bristol Myers Squibb Co.); primary endpoint is confirmed best overall response rate
Elios Therapeutics LLC, of Austin, Texas TLPLDC vaccine Tumor lysate, particle-loaded, dendritic cell Stage III or stage IV melanoma at high risk of recurrence following complete surgical resection Data from phase IIb trial showed 3-year survival was 96% for the vaccine compared to 77% for placebo; disease-free rate after 3 years was 52% for vaccine and 27% for placebo 
Hepion Pharmaceuticals Inc., of Edison, N.J. CRV-431  Cyclophilins inhibitor Nonalcoholic steatohepatitis Treated first of 18 patients in phase IIa Ambition study designed to test the safety, tolerability and pharmacokinetics of the drug; biomarkers will also be measured
KBP Biosciences Co. Ltd., of Princeton, N.J. KBP-5074 Mineralocorticoid receptor antagonist  Advanced (stage 3b/4) chronic kidney disease and uncontrolled hypertension Completed treatment of patients in the phase IIb Block CKD study; top-line data expected in the fourth quarter of 2020
Palatin Technologies Inc., of Cranbury, N.J. PL-9643 Melanocortin MC1/MC5 receptor agonist Dry eye disease Completed enrollment in the study; data expected in the fourth quarter of 2020
Phase III
Cytodyn Inc., of Vancouver, Wash. Leronlimab Monoclonal antibody targeting the CCR5 receptor Severe and critical COVID-19 After review of safety data from 149 patients, the independent data safety monitoring committee recommended continuing the study
Pfizer Inc., of New York Lorbrena (lorlatinib) ALK inhibitor Previously untreated advanced ALK-positive non-small-cell lung cancer  An interim analysis of the Crown study found Lorbrena improved progression-free survival compared to Xalkori (crizotinib); results to be presented at an upcoming medical congress

Notes

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

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