Mer­ck un­wraps full PhI­II da­ta on the cen­ter­piece from its $11.5B Ac­celeron buy­out: #ACC23

NEW OR­LEANS — Mer­ck says so­tater­cept, Ac­celeron’s lead drug be­fore the Big Phar­ma bought it for $11.5 bil­lion, sig­nif­i­cant­ly im­proved scores on an ex­er­cise test in a piv­otal tri­al for pul­monary ar­te­r­i­al hy­per­ten­sion (PAH). Now, Mer­ck is work­ing to­ward an FDA fil­ing for what it hopes can one day be a block­buster drug.

In its ran­dom­ized Phase III STEL­LAR tri­al with 323 pa­tients, so­tater­cept in ad­di­tion to stan­dard care im­proved scores on 6 minute walk­ing dis­tance (6MWD) — a com­mon mea­sure of per­for­mance in heart con­di­tion tri­als and the pri­ma­ry end­point of the study — by about 40 me­ters com­pared to place­bo and stan­dard care at 24 weeks of treat­ment. The da­ta were pre­sent­ed at the Amer­i­can Col­lege of Car­di­ol­o­gy an­nu­al meet­ing in New Or­leans and al­so pub­lished in the New Eng­land Jour­nal of Med­i­cine.

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