BioX­cel scores an­oth­er win with re­for­mu­lat­ed Pfiz­er seda­tive, this time in an Alzheimer's symp­tom

Less than six months af­ter re­port­ing pos­i­tive Phase III re­sults for its lead pro­gram in treat­ing ag­i­ta­tion re­lat­ed to schiz­o­phre­nia and bipo­lar dis­or­der, small AI biotech BioX­cel fol­lowed up Tues­day with top-line da­ta in an ear­ly stage tri­al for ag­i­ta­tion in de­men­tia and Alzheimer’s dis­ease.

The ex­per­i­men­tal drug, known as BX­CL501, met its pri­ma­ry and sec­ondary end­points in the high­er evalu­able dose of a 54-pa­tient Phase Ib/II tri­al, BioX­cel an­nounced, in­duc­ing a sta­tis­ti­cal­ly sig­nif­i­cant calm­ing ef­fect com­pared to place­bo with no se­vere or se­ri­ous side ef­fects. With the da­ta in hand, BioX­cel plans to meet with the FDA some­time in the first half of 2021 be­fore launch­ing a late-stage study some­time af­ter­wards.

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