Bad week for dementia R&D after Axovant howler and another failed trial
A bad week for dementia research just got worse after Axovant embarrassingly admitted it a major error in its trial results and yet another trial failure – this time involving Lundbeck’s drug, idalopirdine.
Trial results published in the Journal of the American Medical Association showed that idalopirdine neither improved cognition nor limited the decline patients in mild to moderate Alzheimer’s disease.
The news comes after Pfizer said it will scrap its early-stage Alzheimer’s and Parkinson's research programmes.
Swiss biotech Axovant had already announced disastrous trial results showing that its intepirdine actually worsened symptoms of dementia in some cases.
But Axovant compounded this with a howler of a mistake in a trial of another drug, nelotanserin, in Lewy body dementia and Parkinson’s disease patients who are suffering from hallucinations.
The company wrongly said the “p” value in an assessment of positive symptoms showed a statistically significant improvement – but in fact the value instead showed only a numerical improvement that was as likely to have been caused by chance than by the effect of the drug.
Axovant still plans to discuss results with the FDA, hoping to start a trial that will confirm the drug’s efficacy.
Axovant's CEO David Hung
CEO David Hung said the mistake was caused by a "transcription error", which did not wash well with investors at the JP Morgan conference in San Francisco, where biotechs aim to attract investment for forthcoming projects.
There was yet more disappointment in dementia research when three studies into Lundbeck's idalopirdine showed the drug did not improve symptoms of in mild to moderate Alzheimer’s.
Findings were based on data from the trials involving 2525 patients aged at least 50 in 34 countries, with 2254 (89%) completing the studies.
But the results showed only a slight difference with placebo over the 24-week trials, and study authors concluded that findings do not support treatment for Alzheimer’s.
In an interview with the Guardian, study co-author professor Clive Ballard, from the University of Exeter, said the results were disappointing given the promise shown in previous trials.
Ballars said idalopirdine is “almost dead”, saying that data from patients at greater risk of decline, such as those with clumps of amyloid in their brains, needed to be reanalysed to ensure results had not been skewed.
Nevertheless, there remains hope of a breakthrough in Alzheimer's disease - foremost among these hopes is Biogen's phase 3 candidate adacanumab. Preliminary results from its phase 3 trials won’t be ready until November 2019, but a phase 1b study suggests the drug has an impact on amyloid plaque formation and slows clinical decline in patients.