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Lundbeck trial failure dashes hopes in Alzheimer's once again

Phase III trial fails to substantially improve cognition despite promising phase II data
Lundbeck

A phase III trial of Lundbeck's 5-HT6 inhibitor idalopirdine has failed to meet its objectives in the first of three pivotal trials in Alzheimer's disease, despite promising phase II results.

Idalopirdine (Lu AE58054) appeared to be safe and showed evidence of "weak efficacy" in the phase III STARSHINE study, which enrolled patients with mild to moderate Alzheimer's. However, neither of the two doses was able to achieve the target improvement in cognition as measured by the ADAS-Cog rating scale when added to background therapy with donepezil, a cholinesterase inhibitor.

Lundbeck said it was disappointed by the outcome, but was waiting for the results of two other trials of idalopirdine - STARBEAM and STARBRIGHT - before taking any decisions on the programme. Those trials are due to report results in the first quarter of 2017.

The setback is a blow for the Alzheimer's community as well as for Lundbeck, whose shares took a sizeable tumble following the announcement, even though most analysts have rated the development programme as a long shot. Idalopirdine is being developed in partnership with Japanese drugmaker Otsuka.

The news wreaked havoc on the shares of Axovant, another company developing a 5-HT6 inhibitor for Alzheimer's. Axovant's intepirdine candidate - licensed from GlaxoSmithKline in 2014 - is also in a phase III trial in mild-to-moderate Alzheimer's dementia and is due to generate results in October 2017.

The company tried to put a positive spin on the results, saying that Lundbeck's disappointment could give it a chance to bring the first new treatment for Alzheimer's to market since 2003. Investors did not wholly buy that - with the company's shares losing a third of their value before closing down around 12% yesterday.

While most drugs in development at the moment for Alzheimer's disease are targeting the amyloid beta protein found in the characteristic plaques that are seen in the brains of patients, 5-HT6 inhibitors take a different approach.

Antagonism of the 5-HT6 receptor designed to work in tandem with current neurotransmitter-boosting drugs such as cholinesterase inhibitors or NMDA antagonists, which attempt to relieve symptoms rather than affecting the underlying neurodegeneration in Alzheimer's.

Idalopirdine and intepirdine promote the release of acetylcholine as well as other neurotransmitters thought to improve cognition and function, and the hope is they could be used to boost the modest and often short-lived effects of donepezil and other Alzheimer's drugs.

Article by
Phil Taylor

23rd September 2016

From: Research

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