Ligand Says Phase 3 Study Of Eltrombopag For Pediatric CITP Meets Primary Goal

(RTTNews) - Ligand Pharmaceuticals Inc. (LGND) Friday announced that its partner, GlaxoSmithKline Plc (GSK.L, GSK), presented results from Phase 3 study of eltrombopag in pediatric patients with chronic immune (idiopathic) thrombocytopenic purpura or cITP, and that the results met its primary endpoint.

The Phase 3 study called PETIT2 evaluated efficacy of eltrombopag compared to placebo in pediatric patients with cITP.

The company noted that eltrombopag achieved a statistically significant improvement in platelet counts, with about 40 percent of patients treated with eltrombopag attaining a consistent platelet response for 6 of 8 weeks compared to placebo.

PETIT2 was 2-part, double-blind, randomized placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag in pediatric patients with previously treated cITP. The multi-center study enrolled 93 subjects at 38 centers in 14 countries. The initial phase of the study compared eltrombopag to placebo for 13 weeks.

According to Ligand, the safety profile was consistent with the established profile for eltrombopag and no new safety concerns were observed.

Eltrombopag is marketed as Promacta in the U.S. and as Revolade in Europe and other countries across the world. Eltrombopag is not approved or licensed anywhere in the world for use in chronic immune (idiopathic) thrombocytopenic purpura in the pediatric setting.

GlaxoSmithKline also said it is moving forward with planned regulatory submissions for a pediatric indication in cITP later this year.

LGND closed Thursday's regular trading at $66.61 on the Nasdaq. In the pre-market activity on Friday, the shares are up 1.34 percent.