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

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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.