Galec­to shelves high dose of IPF drug af­ter SAE im­bal­ance; Long­time Aveo part­ner hands back HER3 an­ti­body

Galec­to $GLTO is yank­ing the top dose of its IPF drug GB0139 in a clin­i­cal study af­ter the safe­ty mon­i­tor­ing board flagged an im­bal­ance of ad­verse events in the study point­ing to the ther­a­py.

Galec­to ex­pects to con­tin­ue re­cruit­ing pa­tients who are not tak­ing nintedanib or pir­fenidone at screen­ing and who would be ran­dom­ized to re­ceive GB0139 3 mg or place­bo. The DSMB rec­om­mend­ed the pa­tients ran­dom­ized to the 10mg group and all those tak­ing nintedanib or pir­fenidone should be dis­con­tin­ued from the study. Based on these rec­om­men­da­tions, the Com­pa­ny plans to work with both the study in­ves­ti­ga­tors and the ap­pro­pri­ate reg­u­la­to­ry au­thor­i­ties to im­ple­ment these changes prompt­ly.

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