Genkyotex Announces Update for Near Term Clinical Development Plan for Setanaxib
(Paris:GKTX) (Brussels:GKTX)
(Euronext Paris Brussels: FR0013399474 GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced clinical and governance updates.
Clinical update
Following the positive results from the Phase 1 study announced in January of 2021, which evaluated higher doses of setanaxib in healthy subjects, Genkyotex is planning to initiate a pivotal Phase 2/3 study in primary biliary cholangitis (PBC), starting in the 2
nd half of 2021, with final design and protocol details subject to feedback from the US Food and Drug Administration (FDA).
In addition, the Company plans to initiate this year a Phase 2 proof-of-concept study in patients with head and neck cancer. The trial will evaluate administration of setanaxib, targeting cancer associated fibroblasts (CAFs), in conjunction with immunotherapy.
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