Company Product Description Indication Status
Phase I
H. Lundbeck A/S, of Copenhagen Lu-AF95245 KCNQ voltage-gated potassium channel stimulator Undisclosed Study in healthy young men terminated
Phase II
Amgen Inc., of Thousand Oaks, Calif. Apremilast PDE4 inhibitor Rheumatoid arthritis Study terminated due to lack of efficacy 
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO-140) CCR5 antagonist Severely and critically ill COVID-19 Started enrollment in phase IIb/III trial of 54 patients treated with drug or placebo for 2 weeks; primary endpoint is mortality rate at 28 days; secondary endpoint is mortality rate at 14 days
Five Prime Therapeutics Inc., of South San Francisco Bemarituzumab Anti-FGFR2b antibody Gastric and gastroesophageal junction cancer Originally initiated as phase I/III trial, the Fight study is being converted to phase II randomized, double-blind trial, based on about 150 patients enrolled; study expected to have sufficient number of progression-free survival and overall survival events to generate clinically meaningful data by end of 2020 or early 2021
Flexion Therapeutics Inc., of Burlington, Mass. Zilretta (triamcinolone acetonide injectable suspension) Activates glucocorticoid receptor Shoulder osteoarthritis and adhesive capsulitis Study discontinued; company aims to start new trial at later date
Kadmon Holdings Inc., of New York KD-025 Oral inhibitor of ROCK2 Systemic sclerosis Enrollment delayed due to COVID-19
Millendo Therapeutics Inc., of Ann Arbor, Mich. Nevanimibe  Adrenal-selective inhibitor of acyl-CoA:cholesterol acyltransferase  Classic congenital adrenal hyperplasia Due to COVID-19, new patients are not being actively enrolled in phase IIb study at this time; company expects to conduct interim review of current dataset for enrolled patients by the third quarter of 2020
Protagonist Therapeutics Inc., of Newark, Calif. PTG-300 Hepcidin mimetic Polycythemia vera All 6 patients treated with doses from 10 mg to 28 mg per protocol had hematocrit levels under control (below 45%) and no need for phlebotomy; a 7th patient had an unintended dose interruption, required a single phlebotomy, and remains on study
Revance Therapeutics Inc., of Newark, Calif. RT-002 Neuromodulator Upper limb spasticity Disclosed pause in enrollment in Juniper trial in adults due to COVID-19
Savara Inc., of Austin, Texas Molgradex  Inhaled formulation of recombinant human GM-CSF Nontuberculous mycobacterial lung infection Due to COVID-19 concerns, company closed enrollment in phase IIa Encore study
Scholar Rock Inc., of Cambridge, Mass. SRK-015 Latent myostatin inhibitor Spinal muscular atrophy COVID-19-related restrictions have impacted patient access sites in Topaz trial, which have led to missed or delayed doses or assessments in some patients and affected ability to monitor trial data collected by sites; interim data now expected in fourth quarter of 2020, roughly a 1-month delay to previous guidance
Phase III
Daewoong Pharmaceutical Co. Ltd., of Seoul, South Korea Fexuprazan Potassium-competitive acid blocker Gastroesophageal reflux disease Data unveiled in Digestive Disease Week 2020 abstract from study in erosive esophagitis showed 99% mucosal healing rate at week 8; also improved symptom relief, particularly exhibiting significantly faster and better heartburn relief vs. esomeprazole 

Notes

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

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