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ARTICLE | Clinical News

Valneva falls on IC43 vaccine trial update

November 1, 2013 1:02 AM UTC

Valneva SE (Euronext:VLA; VSE:VLA) slid EUR 0.65 (12%) to EUR 4.80 on Thursday after an interim analysis by a DMC found the company's IC43 vaccine met the pre-specified criterion for futility on the primary endpoint in a Phase II/III trial to vaccinate against Pseudomonas aeruginosa bacterial infections. Valneva, which halted the trial, declined to disclose the criterion for futility. However, the company said there was a "clinically meaningful" difference on the endpoint between the IC43 plus standard of care (SOC) and placebo plus SOC arms. Valneva said the trial will require protocol amendments "to have a good chance" to meet the primary endpoint and said it will discuss possible trial modifications with the DMC and regulatory authorities. The company hopes to re-initiate the trial early next year. IC43 is a recombinant subunit vaccine consisting of two outer membrane proteins of P. aeruginosa. ...

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