Amid all the talk about aducanumab and whether it can be approved in Alzheimer’s disease next year in a classic phoenix from the flames tail, Biogen has served up another trial flop.
In a relatively brief release this morning, the Big Biotech said a midstage test of its experimental med gosuranemab in progressive supranuclear palsy (PSP) failed to hit statistical significance in its primary endpoint.
It also failed on secondary endpoints in the so-called Passport trial, which was trying to help patients with PSP, a degenerative disease involving the gradual deterioration and death of specific volumes of the brain.
Testing for the drug against this target will now “not be pursued” Biogen said, which licensed the drug from Bristol-Myers Squibb.
But it’s not the end of the line for the drug, as a phase 2 test, known as Tango, will continue. And guess what it’s targeting? That’s right, Alzheimer’s. It says this makes senses “given differences in disease pathology.”
The drug is a humanized monoclonal antibody that targets N-terminal tau, one of two main theories after amyloid on what can cause Alzheimer’s, and can also cause other central nervous system disorders, such as PSP.
“We are disappointed with the efficacy results of the Phase 2 Passport study,” said Alfred Sandrock Jr., M.D., Ph.D., the new executive vice president of R&D and chief medical officer at Biogen. “We remain unwavering in our commitment to advancing therapies that have the potential to address the significant unmet medical needs of people with neurodegenerative diseases who are faced with limited to no treatment options.”
This comes after Biogen saw a major failure for its other Alzheimer’s drug, aducanumab, earlier this year, although some data dredging and a seemingly more complimentary FDA means it will be trying for an approval next year, which some believe it could actually pull off.
Analysts at Jefferies said this latest flop was a “pipeline setback, but unlikely a surprise to the market” and follows other failures from drugs with similar mechanisms, like AbbVie’s attempt that flopped in the summer.
In a note to clients, the firm said: “Indeed, combined with what we knew from AbbVie earlier in July which is their phase 2 of a nearly-identical tau antibody that binds the N-terminus of tau also failed at an interim futility (stopped early due to no efficacy) makes it pretty clear the tau hypothesis is tricky as PSP is one of the most highly prevalent 'tauopathy' diseases due to significantly high over-expression of tau and the aggressive nature of the disease.”