Lundbeck brings latest Alzheimer's failure
- Lundbeck announced during its fourth quarter earnings on Wednesday that two Phase 3 trials —STARBEAM and STARBRIGHT — in its development program for Alzheimer’s disease drug idalopirdine did not demonstrate efficacy.
- The company’s STARSHINE trial of idalopirdine failed back in September. Now, with the latest news in hand, Lundbeck concluded the three failures do not represent enough efficacy to support a regulatory submission.
- "Neuroscience research is an area associated with higher risks and lower success rates compared to research in other disease areas, and as a consequence, we have to deal with setbacks in our drug developing efforts," said Lundbeck President and CEO Kare Schultz.
Alzheimer’s disease is a notoriously tricky treatment area — so far, there are have been no disease modifying treatments to make it through late-stage testing. These Phase 3 blow-ups have hit companies large and small, with Eli Lilly & Co being the most recent big pharma to get stung by an Alzheimer's failure.
Unlike Lilly, Lundbeck was not trying to modify the disease, but use its 5-HT6 antagonist as an add-on therapy to treat the cognitive deficits which are characteristic of the degenerative disease.
Idalopirdine showed promising results in Phase 2, but failed its first late-stage study in September. Analysts had previously predicted peak sales of $1.7 billion for the drug.
The company did not release details of the failed studies, but is expected to present the results later this year. The Danish drugmaker reported an impairment loss of DKK 140 million ($20.2 million) in 2016 related to the clinical failures of idalopirdine.
Yet, Lundbeck is not giving up in neurology. Schultz noted in the company’s annual report, released on Feb. 8, that there are more than 20 R&D candidates in the pipeline that could result in treatments for psychiatric and neurological disorders.
The failure of idalopirdine could have reproductions for another company called Axovant Sciences. TheBermuda-headquartered biotech is developing another 5-HT6 antagonist known as intepirdine. Axovant's management, however, has said that differences in dosing between the two drugs makes it like comparing apples to oranges.
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