CRITICAL THERAPEUTICS RELEASES RESULTS FROM DISCONTINUED TRIAL
Critical Therapeutics announced the results of its Phase II clinical trial designed to assess the safety and preliminary efficacy of 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 a cardiopulmonary bypass machine. The results from this double-blind, placebo-controlled trial include data from the 102 patients enrolled in the trial prior to March 15 when the company discontinued the trial due to a manufacturing issue related to the drug container closure system.
The trial, which was not powered for efficacy, showed no signal or positive trends in efficacy between patients receiving CTI-01 and those receiving placebo in reducing major complications within 14 and 28 days of surgery. The primary efficacy endpoint for the trial was a composite endpoint measured as a reduction in major complications within 14 and 28 days of surgery. Major complications were defined to include: mechanical ventilation any time after the first 48 hours following surgery; use of intravenous vasoconstrictors any time after the first 48 hours following surgery; acute renal failure; or death. The adverse event profile for patients receiving CTI-01 was similar to that of patients receiving placebo.
After reviewing the final data from the trial, the company plans to assess if there is an opportunity to out-license CTI-01 or to continue development of the drug with a collaborative partner.
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