Af­ter rolling up noth­ing but pos­i­tive PhI­II da­ta for the FDA and EMA, Astel­las' drug for hot flash­es reg­is­ters a fail in Asia

Up un­til now, Astel­las has re­port­ed noth­ing but pos­i­tive late-stage da­ta for its menopause drug fe­zo­line­tant. Just days ago the com­pa­ny her­ald­ed a win for their safe­ty study, which rolled in be­hind pos­i­tive Phase III ef­fi­ca­cy da­ta in 2 tri­als.

But on Mon­day evening, the com­pa­ny con­ced­ed de­feat with an un­ex­plained Phase III flop in Asia.

MOON­LIGHT 1 en­rolled 302 women in Chi­na, Ko­rea and Tai­wan, look­ing for the da­ta need­ed to win ap­proval of the neu­rokinin-3 (NK3) re­cep­tor an­tag­o­nist, a non-hor­mon­al treat­ment de­signed to man­age the sever­i­ty of hot flash­es as­so­ci­at­ed with menopause. But un­able to sig­nif­i­cant­ly beat the place­bo arm, the da­ta failed to back up their case on ef­fi­ca­cy, which may com­pli­cate their pur­suit of an ap­proval in the US and Eu­rope.

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