Massachusetts, USA-based biopharmaceutical company Critical Therapeutics says it has discontined a Phase II clinical trial of its developmental anti-inflammatory compound, CTI-01. The firm says that it has taken the descision based on stability issues associated with the drug that could effect supply integrity, adding that it is undertaking a full evaluation of these issues which has, thus far, identified no significant safety concerns.
Up to the suspension of the study, 102 patients had received the drug. This group will be monitored to establish the compound's safety and efficacy. The company says that once it has resolved the stability issues, and has established the product's efficacy and safety profiles, it will determine the next steps in its development.
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