At­lantic Health­care's drug fails late-stage test; Trans­late Bio breaks out ear­ly CF da­ta

→ Cam­bridge, UK-based At­lantic Health­care dis­closed that the late-stage pro­gram for its ex­per­i­men­tal drug, al­i­cafors­en en­e­ma, has failed in pa­tients with pou­ch­i­tis, a pro­gres­sive dis­ease char­ac­ter­ized by in­flam­ma­tion, ul­cer­a­tion and in­creas­ing­ly un­con­trolled, fre­quent and ur­gent emp­ty­ing of the bow­el (up to 10-20 times a day and night). “Al­though we are dis­ap­point­ed that the Phase 3 tri­al did not achieve sta­tis­ti­cal sig­nif­i­cance, we be­lieve the per­cent­age of pa­tients achiev­ing re­mis­sion in stool fre­quen­cy and the en­do­scop­ic re­sponse ob­served in a num­ber of sub­pop­u­la­tions of pa­tients could be note­wor­thy,” said chief To­by Wil­son Wa­ter­worth. “Hav­ing con­sult­ed with key opin­ion lead­ers and reg­u­la­to­ry ad­vi­sors, we now plan to meet with the U.S. Food and Drug Ad­min­is­tra­tion and Eu­ro­pean Med­i­cines Agency to dis­cuss a path­way to reg­u­la­to­ry ap­proval.”

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