Drug Development

Lundbeck, Otsuka take the latest hit on Alzheimer’s as PhIII drug flops

Denmark’s Lundbeck has just racked up the latest R&D disaster in Alzheimer’s, reporting that its first Phase III study for its 5-HT6 agonist idalopirdine failed.

Dr. Anders Gersel Pedersen, EVP and Chief Scientific Officer at Lundbeck

Dr. Anders Gersel Pedersen, EVP and Chief Scientific Officer at Lundbeck

Weak efficacy scuttled its attempt to hit the primary endpoint on cognition for both doses in the study. And the drug (Lu AE58054) also flopped on the secondary goals, making this a complete rout.

That’s bad news for Axovant $AXON, which also has put a 5-HT6 therapy into pivotal studies after snatching it from GlaxoSmithKline, which recorded a series of trial failures before abandoning the therapy. Axovant enjoyed a blockbuster IPO with its high-risk foray into the field at the height of the biotech boom. Axovant’s shares took a sharp dive — dropping more than 20% — when the news broke today.

It’s also bad news for Otsuka, which struck an $825 million collaboration deal on this drug more than three years ago, gaining co-promotion rights in key areas.

Lundbeck investigators felt that hitting the 5-HT6 receptor should spur the release of chemicals that improve cognition in patients. A number of high-profile efforts aimed at targeting the root cause of Alzheimer’s—which is still not well understood—have foundered in Phase III in recent years.

Alzheimer’s has destroyed billions of dollars worth of drug research programs. Pfizer flushed another 5-HT6 therapy, PF-05212377, earlier this year after its study failed, which also dinged Axovant. Eli Lilly is pursuing a  new late-stage effort on solanezumab, an amyloid beta drug, after it registered a major setback in an earlier late-stage flop. TauRx just tried to claim a success on a different target, after its first Phase III failed. The list goes on and on. But with millions of patients, and no hope for slowing the disease, Alzheimer’s remains the biggest lottery target in biopharma. Any kind of success would be expected to earn billions in annual revenue.

And Baird’s Brian Skorney isn’t giving up on Axovant’s remaining effort on the same target. His remark:

We think that a potential trend on the primary endpoint is consistent with our view that idalopirdine is underdosed and underpowered and inteperdine will succeed where this competitor failed.

Axovant itself shrugged the whole thing off.

Lundbeck, meanwhile, has a couple of late-stage studies left to run. But the CSO doesn’t sound enthusiastic.

“We are disappointed about the outcome of this study,” said Dr. Anders Gersel Pedersen, EVP and Chief Scientific Officer at Lundbeck. “The Phase II data were very encouraging but unfortunately, these data failed to replicate those findings.”

 


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