Shares of biotech drugmaker Critical Therapeutics Inc. set a fresh 52-week low Friday after the company said a mid-stage clinical trial for an anti-inflammatory compound that was stopped early showed no trends that the drug was effective.
The company said the Phase II trial looked to see if the compound CTI-01 was effective in reducing complications 14 to 28 days after heart surgery. However, the study was halted in March after a manufacturing issue arose surrounding the drug's container closure.
Only 102 patients had been enrolled, not enough to show statistical significance for efficacy. But even data from these patients did not show a trend toward effectiveness, the company said.
Critical Therapeutics plans to assess if there is an opportunity to continue development of CTI-01 with a collaborative partner, or to out-license it.
Shares of Critical Therapeutics fell 12 cents, or 4.3 percent, to $2.70 in morning trading on the Nasdaq. Earlier in the session, the stock set a new 52-week low of $2.56. The previous low of $2.73 was set Thursday.
CTI-01 is Ethyl pyruvate. Pyruvate plays a role in metabolism as a free radical scavenger. However, it cannot be useful in the cell alone because it is not stable. Therefore the company has modified it chemically for stability. it is a strong antiinflammatory agent being used in numerous treatments such as ischemic heart disease (heart attack in the ER, stroke and diabetes. There was no difference in CTI-01 from placebo. More than likely it's a stability problem or dosing issue.
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