Protocols

Alnylam spells out just why it scrapped revusiran following patient deaths; Innocoll shares plunge on PhIII flops

alnylam-cmo-akshay-vaisnaw

Akshay Vaisnaw

Alnylam shocked investors $ALNY a few weeks ago when it announced that it will scrap further development of revusiran, its second most advanced RNA drug in the pipeline. CMO Akshay Vaisnaw spelled out the exact imbalance of deaths in the recently suspended revusiran study. From the Q3 analysts call: As we noted previously, as of October 4, there were 18 deaths out of the 206 patients enrolled in the trial, a rate of 8.7% which is line with the national history of this disease. As a reminder, the ENDEAVOUR trial had a randomization of 2-to-1 drug-to-placebo. Therefore, with a perfectly balanced distribution you would expect to have 12 deaths in patients who were receiving revusiran and 6 in patients who were on placebo; however, the 18 deaths were comprised of 16 patients in the revusiran arm and 2 patients in the placebo arm. That’s a statistically significant imbalance, made worse by the subsequent discovery that another patient in the drug arm also died.

Federal prosecutors are considering filing criminal charges in a long-running investigation of alleged price fixing on generic drugs.

Shares of Innocoll $INNL cratered after the biotech acknowledged that its two Phase III studies of a new treatment for diabetic foot ulcers had flopped. The stock plunged more than 40% on the news.


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