PERTH, Australia – Melbourne, Australia-based Opthea Ltd. announced positive top-line results of its phase IIa trial evaluating safety and efficacy of OPT-302 administered with Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) in treatment-refractory patients with persistent diabetic macula edema (DME).
HONG KONG – Takeda Pharmaceutical Co. Ltd. is preparing to take Takhzyro (lanadelumab) to the world stage after announcing its interim results for a phase III hereditary angioedema long-term prophylaxis (HELP) study.
HONG KONG – Singapore-based Tychan Pte. Ltd. is starting a phase I trial for a novel monoclonal antibody (MAb) that specifically targets SARS-CoV-2, the coronavirus that causes COVID-19. The trial is expected to take only around six weeks to complete.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
BEIJING – Nasdaq-listed Chinese vaccine developer Sinovac Biotech Ltd., of Beijing, said the preliminary results of the phase I/II trials of its COVID-19 inactivated vaccine candidate, Coronavac, demonstrated favorable immunogenicity and safety profiles.
HONG KONG – Japan’s Seikagaku Corp. is contemplating the next move for its ONO-5704/SI-613 (diclofenac etalhyaluronate), a treatment for arthritis that it is co-developing with fellow Japanese company Ono Pharmaceutical Co. Ltd.
PERTH, Australia – Melbourne, Australia-based Dimerix Ltd. saw its shares gain 66% on the news that its lead candidate, DMX-200, has been chosen to enter the global REMAP-CAP platform trial as a potential treatment for COVID-19-related acute respiratory distress syndrome (ARDS).
With some positive early data for an antibody to block the COVID-19 virus, Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.
BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.