Pro­tag­o­nist re­ports a PhII fail in ul­cer­a­tive col­i­tis, but ex­ecs are push­ing for­ward any­way

Pro­tag­o­nist Ther­a­peu­tics is hop­ing for a sec­ond chance in ul­cer­a­tive col­i­tis af­ter the biotech pulled the plug on its for­mer lead pro­gram four years ago. And while its fol­low-up ef­fort once again missed the pri­ma­ry goal of a Phase II study, this time ex­ecs are de­ter­mined to charge to­ward the FDA.

In Pro­tag­o­nist’s ran­dom­ized tri­al mea­sur­ing PN-943 at two dose lev­els com­pared to place­bo, re­searchers did not see a sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit in clin­i­cal UC re­mis­sion at the high 450 mg dose, the com­pa­ny re­port­ed Mon­day af­ter­noon. This was the study’s pri­ma­ry end­point, and the biotech did not re­lease hard da­ta show­ing how many pa­tients im­proved at this dose.

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