Trial results for anti-agitation psychiatric drug send Alexza shares soaring after hours
Alexza Pharmaceuticals announced positive results from its second Phase 3 clinical trial of its inhalation drug candidate, AZ-004, otherwise known as Staccato loxapine, being developed to treat acute agitation in patients with schizophrenia or bipolar disorder. The drug’s development is part of a partnership between Mountain View-based Alexza and Symphony Capital, a biotech-focused private equity firm.
Alexza reported that the trials showed that both the 5 mg and 10 mg doses showed a “statistically significant reduction in agitation,” according to a press release it filed with the SEC immediately after the markets closed Tuesday.
The clinical trial enrolled 314 acutely-agitated patients with bipolar I disorder at 17 U.S. clinical centers. The most prominent side effect reported was taste-related dysgeusia, which was rated as mild in all patients and occurred in both drug and placebo dose groups, according to the press release.
The news sent shares of Alexza, which had lost more than 80 percent of their value so far this year, up about 33 cents in after-hours trading, 23 percent higher than their closing price Tuesday of $1.45.
The outcome was a welcome change from preliminary results Alexza released in June for its drug candidate designed to reduce panic attacks that showed no difference in effect to a placebo. That news sent Alexza shares south.
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