Critical Therapeutics has decided to discontinue its Phase II clinical trial of CTI-01, an anti-inflammatory compound. The company said its decision was based on "stability issues" that could affect the integrity of clinical drug supplies. The company said in a statement that it is undertaking an evaluation of these issues and that significant safety concerns have not been identified in the trial to date.
The double-blind, randomized, placebo-controlled, parallel-group clinical trial was designed to determine the safety and efficacy of CTI-01 in patients at risk of complications, including organ damage, while undergoing cardiac surgery involving the use of the cardiopulmonary bypass machine.
Of the 150 planned patients, 102 patients have received study medication. The company will analyze the safety and efficacy data from these patients and expects to report results later this year. Once the company completes its analyses of the safety and efficacy data, as well as its evaluation of the stability issues, it will determine what steps will be taken with regard to future clinical trials of CTI-01.