Ful­crum’s sick­le cell hold re­solved, and tri­al will now fo­cus on more se­vere pa­tients

Ful­crum Ther­a­peu­tics can re­sume test­ing its oral cap­sule in a Phase Ib study in pa­tients with sick­le cell dis­ease, the biotech said Tues­day morn­ing.

The FDA lift­ed the full clin­i­cal hold on FTX-6058, with tri­al re­vi­sions to fo­cus on sick­er pa­tients af­ter the small mol­e­cule spent six months in the wait­ing zone. The study pro­to­col now stip­u­lates pa­tients must have se­vere cas­es of the red blood cell dis­or­der or lack ac­cess to ad­vanced ther­a­pies, ei­ther due to avail­abil­i­ty lim­i­ta­tions or in­sur­ance hin­drances. The tri­al was orig­i­nal­ly de­signed as an all-com­ers study.

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