Critical Therapeutics' CTI-01 phase 2 trial fails primary endpoint

By Elaine Rigoli

Tampa, Fla., Sept. 15 - Critical Therapeutics, Inc. said its phase 2 clinical trial of CTI-01 showed no signal or positive trends in efficacy between patients receiving CTI-01 and those receiving a placebo in reducing major complications within 14 or 28 days of surgery, the primary endpoint.

Major complications were defined as death; mechanical ventilation any time after the first 48 hours following surgery; acute renal failure; or a requirement for intravenous vasoconstrictors any time after the first 48 hours following surgery.

The Lexington, Mass., biopharmaceutical company said the adverse event profile for patients receiving CTI-01 was similar to that of patients receiving a placebo.

The company said it may seek a collaborative partner or out-license CTI-01, an anti-inflammatory compound in patients at risk of serious complications, including organ damage, while undergoing major cardiac surgery involving the use of the cardiopulmonary bypass machine.

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