Results

Lundbeck reads last rites on another failed PhIII Alzheimer’s program

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

Lundbeck and Otsuka have racked up two more Phase III flops for their 5-HT6 antagonist idalopirdine, setting up corporate last rites for yet another failed Alzheimer’s drug.

The Danish biotech said in their Q4 roundup today that “the efficacy profile with idalopirdine observed in these studies and in the (first) STARSHINE study do not demonstrate efficacy to support a regulatory submission.”

Like others before it, Lundbeck was following up on animal and early human data that demonstrated that the 5-HT6 receptor plays a role in modulating neurotransmitters in the brain that play a key role in learning. While it appeared to be safe, it failed to prove in large studies that it could improve cognition when added to the standard therapies now in use.

Pfizer and GlaxoSmithKline have both been down this road before. GSK, though, sold their failed 5-HT6 drug to Axovant $AXON for only $5 million in cash and a promise of future royalties.

Axovant’s Vivek Ramaswamy shrugged off the first Phase III disaster at Lundbeck and isn’t likely to show any alarm now. The company has pointed to the Lundbeck/Otsuka team’s decision to lower the dose going into Phase III as a fatal move while they believe that there’s evidence from an earlier Phase II to support intepirdine’s shot at becoming the first new drug to gain approval for mild to moderate Alzheimer’s in close to 14 years.

Doubts about Axovant have seriously eroded its market cap — which now sits at $1.3 billion — since pulling off a record biotech IPO in 2015.

The remaining value at Axovant, though, is a testament to the continued allure of Alzheimer’s, a terrible disease with no effective therapeutic interventions for millions of patients worldwide. If a developer can get through an R&D field littered with huge failures like solanezumab and bapineuzumab and make it to the market with a drug, the payoff would be worth billions in annual revenue.

The actual data on these Lundbeck studies will be released later. Otsuka inked an $825 million collaboration deal to gain regional marketing rights.


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RAPS Regulatory Convergence 2017