Lex­i­con Phar­ma­ceu­ti­cals an­nounces mid-stage pain fail, blames dos­ing choice

A small Texas biotech is mov­ing a pain can­di­date for­ward in­to late-stage clin­i­cal de­vel­op­ment, de­spite a Phase II fail.

Lex­i­con Phar­ma­ceu­ti­cals told in­vestors Wednes­day that a Phase II proof-of-con­cept tri­al in pos­ther­pet­ic neu­ral­gia failed to meet sta­tis­ti­cal sig­nif­i­cance.

LX9211, which tar­gets AAK1, achieved a re­duc­tion in av­er­age dai­ly pain score (ADPS) of 2.42 from base­line at week 6 com­pared to a re­duc­tion of 1.62 in the place­bo arm. How­ev­er, with a place­bo ad­just­ed dif­fer­ence of 0.80, the p-val­ue of 0.12 made the tri­al and the da­ta sta­tis­ti­cal­ly in­signif­i­cant. Sig­nif­i­cance is met if the p-val­ue is at or be­low 0.05, which in­di­cates a 95% chance that the re­sults aren’t ran­dom.

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