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BIIB Advances Alzheimer's Disease Drug Despite Study Missing Main Goal
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Key Takeaways
Biogen will advance diranersen despite the phase II CELIA study missing its primary endpoint.
BIIB said diranersen reduced tau pathology and slowed decline at all studied doses.
Diranersen targets tau, unlike amyloid-focused AD drugs such as Leqembi and Kisunla.
Shares of Biogen (BIIB - Free Report) declined more than 6% yesterday after the company announced that it would move its experimental tau-targeting Alzheimer’s disease (AD) drug, diranersen, into late-stage development despite the phase II CELIA study missing its primary endpoint.
The primary endpoint of the CELIA study assessed the dose response for change from baseline at week 76 on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score, a widely used clinical scale that measures cognitive and functional decline in AD patients.
Although the study did not demonstrate the expected dose-dependent clinical benefit, pre-specified analyses of cognitive endpoints showed a reduction in clinical decline across all studied doses, particularly in participants receiving the lowest drug dose (60mg). Per Biogen, treatment with diranersen led to ‘robust reductions’ in both cerebrospinal fluid (CSF) tau and tau pathology across all studied doses, with reductions maintained throughout the dosing period. The drug’s safety profile was also consistent with findings from a previously conducted phase Ib study.
BIIB’s Stock Performance
While the biomarker and cognitive trends were viewed as encouraging by some investors despite the primary endpoint miss, the lack of detailed supporting data appeared to limit broader market enthusiasm. Investors were also disappointed that Biogen did not disclose a timeline for initiating the late-stage development program for diranersen.
Diranersen remains among the more advanced tau-targeting therapies currently in development for AD, an area many researchers believe could complement existing amyloid-focused treatments or potentially provide improved disease-modifying benefits.
Shares of Biogen have risen 9% year to date compared with the industry’s 1% growth.
Image Source: Zacks Investment Research
Biogen Bets on Tau in Next Phase of AD Drug Development
Diranersen marks Biogen’s latest effort to expand its AD portfolio beyond amyloid-targeting therapies. This drug is being developed in collaboration with Ionis Pharmaceuticals (IONS - Free Report) .
Biogen currently markets AD therapy Leqembi alongside Eisai and previously withdrew Aduhelm following controversy surrounding its regulatory approval and commercial rollout. Unlike those therapies, which target amyloid-beta plaques, diranersen is designed to reduce the production of tau, which is strongly linked to AD progression and cognitive decline.
Another marketed amyloid-targeting AD therapy is Eli Lilly’s (LLY - Free Report) Kisunla. Eli Lilly is also developing experimental candidates targeting tau as interest in alternative AD mechanisms continues to grow across the industry.
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BIIB Advances Alzheimer's Disease Drug Despite Study Missing Main Goal
Key Takeaways
Shares of Biogen (BIIB - Free Report) declined more than 6% yesterday after the company announced that it would move its experimental tau-targeting Alzheimer’s disease (AD) drug, diranersen, into late-stage development despite the phase II CELIA study missing its primary endpoint.
The primary endpoint of the CELIA study assessed the dose response for change from baseline at week 76 on the Clinical Dementia Rating–Sum of Boxes (CDR-SB) score, a widely used clinical scale that measures cognitive and functional decline in AD patients.
Although the study did not demonstrate the expected dose-dependent clinical benefit, pre-specified analyses of cognitive endpoints showed a reduction in clinical decline across all studied doses, particularly in participants receiving the lowest drug dose (60mg). Per Biogen, treatment with diranersen led to ‘robust reductions’ in both cerebrospinal fluid (CSF) tau and tau pathology across all studied doses, with reductions maintained throughout the dosing period. The drug’s safety profile was also consistent with findings from a previously conducted phase Ib study.
BIIB’s Stock Performance
While the biomarker and cognitive trends were viewed as encouraging by some investors despite the primary endpoint miss, the lack of detailed supporting data appeared to limit broader market enthusiasm. Investors were also disappointed that Biogen did not disclose a timeline for initiating the late-stage development program for diranersen.
Diranersen remains among the more advanced tau-targeting therapies currently in development for AD, an area many researchers believe could complement existing amyloid-focused treatments or potentially provide improved disease-modifying benefits.
Shares of Biogen have risen 9% year to date compared with the industry’s 1% growth.
Image Source: Zacks Investment Research
Biogen Bets on Tau in Next Phase of AD Drug Development
Diranersen marks Biogen’s latest effort to expand its AD portfolio beyond amyloid-targeting therapies. This drug is being developed in collaboration with Ionis Pharmaceuticals (IONS - Free Report) .
Biogen currently markets AD therapy Leqembi alongside Eisai and previously withdrew Aduhelm following controversy surrounding its regulatory approval and commercial rollout. Unlike those therapies, which target amyloid-beta plaques, diranersen is designed to reduce the production of tau, which is strongly linked to AD progression and cognitive decline.
Another marketed amyloid-targeting AD therapy is Eli Lilly’s (LLY - Free Report) Kisunla. Eli Lilly is also developing experimental candidates targeting tau as interest in alternative AD mechanisms continues to grow across the industry.
Biogen Inc. Price
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BIIB’s Zacks Rank
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.