First Wave’s mid-stage trial for yeast-derived cystic fibrosis drug ‘likely’ failed, company says

First Wave Bio­Phar­ma’s at­tempt to best the cur­rent treat­ment op­tion for ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy in cys­tic fi­bro­sis has “like­ly” failed.

Thurs­day morn­ing, the Bo­ca Ra­ton, FL biotech an­nounced that based on topline da­ta, “it is like­ly” that its Phase II tri­al for adruli­pase, a yeast-de­rived en­zyme to treat EPI, missed its pri­ma­ry ef­fi­ca­cy end­point. In 13 pa­tients, the tri­al was com­par­ing those on adruli­pase af­ter a three-week treat­ment pe­ri­od to when they were on PERT, the cur­rent en­zyme re­place­ment op­tion which is de­rived from pigs, at base­line.

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