Reg­u­la­tors or­der AB Sci­ence to halt tri­al work on PhI­II ALS drug, de­mand­ing proof it's cleaned up

Just weeks af­ter lay­ing out claims on pos­i­tive Phase III da­ta for their ALS drug ma­sitinib, French reg­u­la­to­ry au­thor­i­ties are drop­ping the ham­mer on AB Sci­ence, or­der­ing a halt to clin­i­cal re­search work on the drug un­til the biotech can prove it’s com­pli­ant with rules gov­ern­ing drug study con­duct.

In a re­lease out ear­ly Fri­day, the biotech said that the Agence Na­tionale de la Sécu­rité des Médica­ments is de­mand­ing an ex­ter­nal au­dit to clear their work on tri­al pro­ce­dures. AB Sci­ence says that the ANSM ze­roed in on a trou­bled study —AB06006 — in­volv­ing ma­sitinib in treat­ing mas­to­cy­to­sis. But those prob­lems, the biotech kicked back, all oc­curred be­tween 2009 and 2015, be­fore they put a new qual­i­ty con­trol sys­tem in place.

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