Lundbeck's idalopirdine fails in Phase III AD trial

14:27 EDT 22 Sep 2016 | BioCentury

H. Lundbeck A/S (CSE:LUN) said idalopirdine (Lu AE58054) missed the primary and secondary endpoints in the Phase III STARSHINE study to treat mild to moderate Alzheimer's disease. Idalopirdine is a serotonin (5-HT6) receptor antagonist.

The news drove down shares of Axovant Sciences Ltd. (NYSE:AXON), whose serotonin receptor antagonist intepirdine (RVT-101) is in a Phase III trial to treat AD. Axovant fell $2.16 (12%) to $15.14 on Thursday.

Lundbeck did not disclose STARSHINE's data, but said idalopirdine "showed a weak efficacy profile" on the primary endpoint of reductions in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), and "did not show separation from placebo" on the study's secondary endpoints.

The company said its other Phase III studies of idalopirdine, STARBEAM and STARBRIGHT, will continue as planned.

Avoxant's 24-week Phase III MINDSET trial is evaluating intepirdine in mild to moderate AD patients on donepezil therapy. Avoxant purchased intepirdine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in 2014.

In a statement, Axovant said idalopirdine's Phase III failure was "expected" because STARSHINE included significant changes relative to Lundbeck's Phase II program, including lower and less frequent dosing.

Pfizer Inc. (NYSE:PFE) discontinued development of its serotonin receptor antagonist in February (see BioCentury Extra, Feb. 2).

Lundbeck gained DKK2.40 to DKK271.70 on Thursday. It announced the news after market close in Copenhagen.

Original Article: Lundbeck's idalopirdine fails in Phase III AD trial


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