With positive top-line data reported for Axsome Therapeutics Inc.’s oral migraine candidate, AXS-07, in its INTERCEPT trial, the company and the candidate have notched two successful phase III trials in little more than three months.
Menlo Therapeutics Inc. announced a double dose of bad news with negative results for two phase III trials testing its NK1 receptor antagonist, serlopitant, as a treatment for pruritus (itch) associated with prurigo nodularis, a skin disease characterized by hard, itchy nodules.
DUBLIN – Immunomedics Inc. is stopping the phase III Ascent trial of its antibody-drug conjugate, sacituzumab govitecan, in triple-negative breast cancer (TNBC) on the unanimous recommendation of the study’s independent data safety monitoring committee, after a scheduled look at the study data uncovered what the company called “compelling efficacy.”
LONDON – Izana Bioscience Ltd. has become the third company to supply an anti-GM-CSF antibody for compassionate use against COVID-19, announcing namilumab, currently in phase IIb testing in the treatment of rheumatoid arthritis and ankylosing spondylitis, will be used to treat 20 patients with severe respiratory symptoms.
HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeterna Zentaris, American Brivision, Auris, Axsome, Bryn Pharma, Catalyst, Compugen, Cytodyn, Immunomedics, Incyte, Inovio, Janssen, Menlo, Millendo, Oxthera, Sun Biopharma, Windtree, Yiviva.
During its recent fourth-quarter and full-year earnings report, Foster City, Calif.-based Mirum Pharmaceuticals Inc. provided an update on the apical sodium dependent bile acid transporter (ASBT) inhibitor maralixibat for Alagille syndrome (ALGS), which will be the subject of a rolling NDA starting in the third quarter of 2020.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Axon, Denali, Neurocrine, Novan, Oryzon, Regeneron, Restorbio, Sanofi, Umecrine, Urogen, Voyager.
Indian scientists have discovered a previously unknown mechanism underlying life-threatening sepsis and proposed a new treatment strategy centered upon cell-free chromatin (cfCh), they reported in the March 4, 2020, edition of PLOS ONE. Notably, they showed that sepsis could be caused by cfCh released from dying host cells following microbial infection.
DUBLIN – Ose Immunotherapeutics SA finds itself in the difficult place of hitting the primary endpoint of the first part of a phase III trial of Tedopi, a therapeutic vaccine, in non-small-cell lung cancer (NSCLC) while having to terminate the study without completing the crucial second part.
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