The class of molecules behind one of biotech's biggest AlzheimerAlzheimer's failures gets a new lease on life

02 Jul 2021
endpts.com
Gene TherapyAntibodyAccelerated ApprovalIPO
Denovo Biopharma has spent the last decade trying to resurrect drugs that failed at other companies, but it had never waded into a class of molecules that failed quite as spectacularly as 5HT6 serotonin, an oft-failed shot on goal in Alzheimer’s. But, in the wake of Biogen’s derided success with aducanumab, all options appear back on the table. On Thursday, the San Diego-Chinese biotech announced it’s licensed the once-abandoned Alzheimer’s drug idalopirdine from Lundbeck for an undisclosed fee. Idalopirdine is notable not only because it failed a Phase III Lundbeck and Otsuka ran a half-decade ago, but also because it inhibits a brain receptor called 5HT6 serotonin. That’s the same class of molecules as intepirdine, the Alzheimer’s drug Vivek Ramaswamy licensed from GlaxoSmithKline in 2014 as the first big molecule for a portfolio company he called Roivant. He then used it to launch a $360 million IPO for Roivant’s first subsidiary, Axovant. Roivant would of course grow into a many-tentacled, $7 billion behemoth, but the old GSK drug failed dramatically in 2017; a Phase III trial showed “no difference” between placebo and treatment arms. Axovant is now a gene therapy company with a new name and a market cap 1/15th the size. Denovo will try to do for serotonin inhibitors what it has tried to do with the rest of the zombie drugs in its pipeline: devise new biomarkers to target a drug to the precise subset of patients where it has the best chance of working. So far, Denovo has yet to release efficacy data from any of their programs showing the strategy works, but last year it convinced investors to pour $83.5 million to fund Phase III trials for enzastaurin, a kinase inhibitor that Eli Lilly spent years trying to develop for different cancers. Denovo claims to have a biomarker to select the right patients in the blood cancer DLBCL and in brain tumors. The new licensing deal comes in the wake of the FDA’s controversial decision to approve Biogen’s amyloid-clearing antibody Aduhelm for Alzheimer’s, a move that has already spurred large pharma companies to accelerate development of their own amyloid-clearing drugs. They hope to similarly win accelerated approval by showing their drugs can clear amyloid, rather than by proving it can slow cognitive decline. Denovo, though, likely won’t have that route available. Their molecule works by a different mechanism. In theory, it boosts production of a neurotransmitter in the brain, temporarily preserving memory. Although Lundbeck hasn’t studied the molecule in years, the Danish drugmaker is hedging its bets. If Denovo shows it can work in Phase II, Lundbeck holds an option to reacquire it for undisclosed terms.
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