Small biotech Viking slapped with clin­i­cal hold af­ter FDA says its PhIb tri­al is ac­tu­al­ly PhII

A mi­cro­cap biotech look­ing to de­vel­op a new drug for a rare ge­net­ic dis­ease will have to slam the brakes on a clin­i­cal study af­ter an ap­par­ent mis­com­mu­ni­ca­tion with reg­u­la­tors.

The FDA placed a clin­i­cal hold on a Viking Ther­a­peu­tics study, forc­ing a halt on tri­als for the biotech’s X-linked adrenoleukody­s­tro­phy (X-ALD) pro­gram, Viking an­nounced Mon­day. While Viking has de­scribed the study as a Phase Ib tri­al, reg­u­la­tors con­sid­er it to be a Phase II study, ac­cord­ing to the biotech.

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