Company Product Description Indication Status
Agios Pharmaceuticals Inc., of Cambridge, Mass. Mitapivat Pyruvate kinase stimulator Thalassemia FDA granted orphan drug designation
Global Blood Therapeutics Inc., of South San Francisco Oxbryta (voxelotor)  Hemoglobin alpha subunit modulator Sickle cell disease Following type B meeting with FDA, company plans to submit NDA for age-appropriate formulation to treat 4- to 11-year-olds under accelerated approval pathway
Immune Therapeutics Inc., of Winter Park, Fla. CYTO-201 (metenkefalin) Immunotherapy COVID-19 infection Partner and former subsidiary Cytocom Inc. submitted IND application to FDA for open-label phase II study to assess CYTO-201 as adjunct to standard of care to mitigate disease progression 
Immunic Inc., of New York IMU-838 (vidofludimus) Dihydroorotate dehydrogenase inhibitor COVID-19 infection FDA authorized initiation of phase II Calvid-1 trial at U.S. sites
Immuron Ltd., of Melbourne, Australia Undisclosed Undisclosed Acute infectious diarrhea Research collaborator U.S. DoD Naval Medical Research Center requested pre-IND meeting with FDA on phase II development of oral therapeutic targeting Campylobacter and E. coli-based infections; IND application expected later this year, with 2 studies to commence during first half of 2021
Revive Therapeutics Ltd., of Toronto Bucillamine Cysteine derivative COVID-19 Pre-CTA meeting with Health Canada provided guidance for proposed clinical study design and information required for CTA submission; company aims to file IND with FDA in June 2020, followed by CTA in Canada for phase III study
Saniona AB, of Copenhagen Tesomet (tesofensine + metoprolol) Beta 1 adrenoceptor antagonist Prader-Willi syndrome During pre-IND meeting, FDA endorsed proposed filing via 505(b)2 pathway and indicated agreement on proposed design, doses and duration of potential phase IIb trial


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

No Comments