Company Product Description Indication Status
Akari Therapeutics plc, of New York Nomacopan Complement C5 factor inhibitor; leukotriene BLT receptor antagonist Bullous pemphigoid At end-of-phase-II meeting, FDA agreed to phase III design for treatment of moderate to severe disease, with primary endpoint of complete remission on minimal oral corticosteroids (OCS) and secondary endpoint of reduction in cumulative OCS; pivotal trial expected to begin in first half of 2021
Arca Biopharma Inc., of Westminster, Colo. AB-201 Tissue factor inhibitor COVID-19 infection Following pre-IND consultation with FDA under coronavirus treatment acceleration program, IND submission for phase IIb trial expected in September 2020, with trial to begin as early as fourth quarter of 2020
Ascendis Pharma A/S, of Copenhagen, Denmark Transcon C-type natriuretic peptide Induces natriuresis Achondroplasia European Commission granted orphan drug designation
Epirium Bio Inc., of San Diego EPM-01 Mitochondrial complex I stimulator Becker muscular dystrophy European Commission granted orphan designation
Eyegate Pharmaceuticals Inc., of Waltham, Mass. Moxigel Antibiotic in ocular bandage gel Bacterial conjunctivitis Received positive feedback from the pre-IND meeting with the FDA; plans to file an IND in first half of 2021
India Globalization Capital Inc., of Potomac, Md. IGC-AD1 Cannabinoid formulation Mild to severe dementia due to Alzheimer’s disease FDA authorized the IND for a phase I study; plans to start 12-subject multiple ascending-dose study
Innovent Biologics Inc., of Suzhou, China, and Eli Lilly and Co., of Indianapolis Tyvyt (sintilimab) Monoclonal antibody targeting PD-1 First-line squamous non-small-cell lung cancer National Medical Products Administration of China accepted the supplemental NDA for use of the drug in combination with Gemzar (gemcitabine, Lilly) and platinum
Kahr Medical Ltd., of Jerusalem DSP-107 Targets CD47 and 41BB Advanced solid tumors FDA cleared the IND for a phase I/II study testing the drug as a monotherapy and in combination with Tecentriq (atezolizumab, Roche Holding AG)
Kineta Inc., of Seattle KCP-506 Alpha9alpha10 nicotinic acetylcholine receptor antagonist Healthy subjects (eventually neuropathic pain) CTA for a phase I study was approved in the Netherlands; plans to start the single and multiple ascending-dose study in the fourth quarter of 2020
Pliant Therapeutics Inc., of South San Francisco PLN-74809 Dual integrin alpha-V/beta-1/6 antagonist Acute respiratory distress syndrome associated with COVID-19 FDA cleared the IND for a phase II study to be started in the second half of 2020
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase-2 inhibitor Hospitalized COVID-19 patients with pneumonia Mexican Federal Committee for the Protection against Sanitary Risks approved the CTA for the 270-patient phase II/III study
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Evinacumab Monoclonal antibody targeting angiopoietin-like 3 Homozygous familial hypercholesterolemia FDA accepted the BLA for a priority review; PDUFA action date is Feb. 11, 2021
Seattle Genetics Inc., of Bothell, Wash. Tukysa (tucatinib) HER2 tyrosine kinase inhibitor Advanced unresectable or metastatic HER2-positive breast cancer Australian regulatory authorities approved use of the drug in combination with Herceptin (trastuzumab, Roche Holding AG)
Theranexus SAS, of Lyon, France BBDF-101 Combination product Batten disease FDA granted orphan drug designation and rare pediatric disease designation

Notes

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

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