Man­u­fac­tur­ing con­cerns spur clin­i­cal hold on small biotech's Alzheimer's tri­al — shares plunge

The FDA is keep­ing an ex­per­i­men­tal Alzheimer’s ther­a­py out of the US for now, plac­ing a clin­i­cal hold on IN­mune Bio’s IND for a Phase II tri­al un­til it can pro­vide ad­di­tion­al in­for­ma­tion on chem­istry, man­u­fac­tur­ing and con­trols.

IN­mune Bio, which gets its name from the ap­proach of lever­ag­ing the in­nate im­mune sys­tem to fight dis­ease, said it was in­formed about the hold via email and ex­pects more de­tails in a lat­er let­ter. In a brief state­ment, it said the agency was look­ing for more in­for­ma­tion about CMC “of the new­ly man­u­fac­tured XPro1595.”

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