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Biotech


TAU, ANTI-INFLAMMATION AND ORALS FORM BIOGEN'S FUTURE ALZHEIMER'S PIPELINE

By Max BayerMar 7, 2024 10:25am
BiogenEisaiLeqembiLilly

Biogen has two clinical-stage Alzheimer's disease assets behind Leqembi, both of
which target tau proteins or their dysfunction. (Ville Heikkinen/Getty Images)

“What does it mean to be a leader in Alzheimer’s disease?”

That’s the question Biogen is asking itself, and the question many of the
company’s peers are working fervently to answer as the heated race to
differentiate from the first batch of Alzheimer’s treatments turns to a simmer. 







Adam Keeney, Ph.D., corporate development chief for the Leqembi co-maker, said
in an interview with Fierce Biotech that Biogen is "not only just satisfied with
[amyloid] beta" and instead "looking at the different pillars of disease."





Keeney says the first stop on the portfolio-building circuit is tau. The
company’s phase 2 antisense drug, BIIB-080, targets the protein buildup that
accompanies amyloid beta in patients with Alzheimer’s. It’s an intrathecal
injection—an injection into the spinal cord to bypass the blood-brain barrier—
which Keeney described as “not ideal” though probably satisfactory for a
first-generation option. But Biogen is planning for and think-tanking easier
methods, like IV delivery and even oral compounds. 

“We're thinking about degraders and molecular glues and different technologies
that we can use,” Keeney said. Biogen already has one oral option in the clinic,
the O-GlcNACase inhibitor BIIB-131, a small molecule that looks to block the
enzyme research has tied to tau’s dysfunction in Alzheimer’s patients. 


RELATED

After tough rightsizing, Biogen looks to newer rare diseases to broaden lens







Keeney described oral delivery as a goal that’s on a “longer time horizon”
routing the work back to the original question: What does it mean to be a leader
in the space? 

Biogen has experienced the ups and downs of Alzheimer's drug discovery more
acutely than probably any company. Its well-documented Aduhelm failure came to a
much-expected conclusion earlier this year, when Biogen wound down all work on
the approved med. Not only was it made obsolete by Leqembi, but the therapy was
a corporate representation of time wasted.

Meanwhile, Eli Lilly pressed on from behind, raising up donanemab, which is
expected to get an FDA ruling any day now. 

The amyloid beta battle may not ultimately be an automatic reflection of
tomorrow’s tau contest, or other options that may be discovered. Deeper into
Biogen’s research work, the company is tinkering with novel anti-inflammatory
targets, Keeney says.



Targeting rogue tau buildup has proven difficult, just like amyloid. Lilly cut a
phase 2 large-molecule zagotenemab in October 2021 after it failed to hit phase
2 endpoints. This followed phase 1 data showing four cases of brain bleeding
(ARIA-H) across three patients, representing 19% of treated patients. Kenney
says it remains to be seen whether that’s a genuine signal tied to tau-busting
treatments—but it's certainly been an issue with Leqembi and donanemab. 

“I think it's probably too early to say there's a signal or not in that,” he
said. “We have no signal that is preventing us to move forward.” 


RELATED

Eisai to drop up to $15M on C2N Diagnostics to boost the reach of Alzheimer's
disease blood tests

Beyond drug development, critical advancements are happening in the Alzheimer’s
diagnostic sector, with companies working to improve the tests that could detect
amyloid buildup. There’s been such improvement in this area that a working group
convened by the Alzheimer’s Association and the National Institute on Aging
recently revised its criteria for diagnosing Alzheimer’s to include blood-based
biomarkers. Keeney says those tests may not immediately be a primary diagnosis,
but a negative result could preclude someone from an additional PET scan. 

“So we're also investing and working with collaborators because there are
blood-brain barrier biomarkers that are out there,” Keeney said, noting they
aren’t yet 100% predictive. “We're helping also get the predictive validity
improved.” 

Despite the blood-based tests needing refinement, authors of the new testing
criteria made clear that the future is now, and some tests provide “excellent
diagnostic performance.”

“The field is now in a transition phase during which plasma biomarkers are being
integrated with traditional CSF and PET biomarkers,” the guidance states. 

BiogenEisaiLeqembiLillyAlzheimer'sAlzheimer's Association
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