Lundbeck failure in Alzheimer's reverberates
- Lundbeck's idalopirdine, its experimental drug for mild-to-moderate Alzheimer's disease, failed to show improvement in patients compared with placebo when paired with Pfizer's donepezil, according to topline results from a Phase 3 study announced Thursday.
- Neither dose of the drug, a selective 5-HT6 receptor antagonist, met the primary endpoint – a reduction in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) score. Two other Phase 3 trials will continue as planned, with results expected in 2017.
- Around 46.8 million people have Alzheimer's disease worldwide, and this could almost triple to 131.5 million by 2050 as the global population ages, according to Alzheimer's Disease International.
Lundbeck has announced its headline results from the STARSHINE idalopirdine Alzheimer's disease study, and it's not the day of celebration that the company had hoped. The response from Anders Gersel Pedersen, EVP and CSO Scientific Officer at Lundbeck, is quietly understated: "We are disappointed about the outcome of this study," he said. "The phase II data were very encouraging but unfortunately, these data failed to replicate those findings," he added.
Idalopiridine failed to show a meaningful difference compared with placebo even in the highest dose group, worrying analysts, which projected peak sales of at least $1.7 billion.
Jefferies analyst Amin Biren is skeptical about the potential outcomes of the two ongoing studies for idalopirdine. However, Biren wrote in a note to investors that he remains confident about the possibilities for a competing drug in the same class that is being developed by Axovant Sciences. Jefferies' Biren points to intepirdine's much longer half-life than idalopirdine, allowing it to deliver a more sustained 24-hour drug exposure.
Lundbeck and its collaborator Otsuka are not alone in their failure. The route to Alzheimer's disease drugs has been one littered with high-profile flops – a study between 2002 and 2012 of Alzheimer's disease clinical trials showed a 99.6% failure rate. Earlier this year, TauRx Therapeutics' LMTX, which targets the "tau tangles" showed no meaningful differences between drug and placebo as measured by standard measures of cognitive and functional ability, although there was benefit in a patient subgroup. Roche and Evotec's sembragiline, in results announced in 2015, did not show benefit in cognition over 52 weeks, and this followed a failure for Roche's gantenerumab the previous year. Biogen's aducanumab and Lilly's solanezumab have both shown mixed results.
Due to the high failure rate, impacts on one drug have a knock on effect across the field, despite differences in approaches, dosing or mechanism of action. Axovant Sciences, which has intepirdine in a Phase 3 trial known as MINDSET, saw shares fall by 12.5% on the news.
- Lundbeck Statement
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