Pli­ant Ther­a­peu­tics re­leas­es longer-term safe­ty, pre­lim­i­nary ef­fi­ca­cy da­ta from PhI­Ia study

A new up­date on Pli­ant Ther­a­peu­tics’ oral drug for id­io­path­ic pul­monary fi­bro­sis (IPF) sug­gests its safe­ty and ear­ly signs of ef­fi­ca­cy are hold­ing up in longer-term fol­low-up, set­ting the stage for a Phase IIb tri­al in the com­ing months.

South San Fran­cis­co-based Pli­ant de­signed the Phase IIa IN­TE­GRIS-IPF tri­al main­ly to tease out whether bex­ote­grast, its lead can­di­date, is safe and well-tol­er­at­ed. But it al­so looked for dose-pro­por­tion­al in­creas­es of drug lev­els in the body for sec­ondary end­points and as­sessed ex­plorato­ry ef­fi­ca­cy end­points such as changes in forced vi­tal ca­pac­i­ty, quan­ti­ta­tive lung fi­bro­sis imag­ing, pa­tient re­port­ed cough sever­i­ty and oth­er bio­mark­ers.

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