Biogen Says New Data Shows Promise For Potential New Generation Of Treatments In Early Alzheimer's Disease

Biogen Inc. BIIB reported new Phase 1b clinical data from the study of BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, in mild Alzheimer's disease (AD).

The data showed favorable trends on multiple exploratory endpoints of cognition and activities of daily living in AD, building upon prior results. These preliminary results showed a reduction of tau protein in the cerebral spinal fluid and tau positron emission tomography (PET) across brain regions.

Biogen's late-breaking results were presented at the 2023 Clinical Trials on Alzheimer's Disease (CTAD) meeting held in Boston, MA from October 24 to 27.

In December 2019, Biogen exercised a license option and obtained a worldwide license to develop and commercialize BIIB080.

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Biogen's BIIB080 is designed to target microtubule-associated protein tau (MAPT) mRNA and reduce production of tau protein. 

The Phase 1b trial and its long-term extension study (LTE) were designed to assess the safety and tolerability of multiple doses in patients with mild dementia due to AD. 

Treatment was generally "well tolerated" throughout the study. 

The majority of adverse events were mild or moderate in severity, of which the most common were headache, back pain, pain in extremity, post-lumbar puncture syndrome and procedural pain.

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"This is the first time we've seen both strong target engagement and favorable trends on clinical outcomes with a novel mechanism targeting tau," said Priya Singhal, Head of Development at Biogen. "While these are preliminary findings, we are excited about these results and continue to enroll the Phase 2 CELIA study. We believe defeating Alzheimer's disease will take different approaches and we are committed to exploring the targeting of tau as a new generation of treatment."

Biogen is conducting recruitment for the Phase 2 CELIA study (NCT05399888), evaluating the potential for this ASO targeting tau to slow the worsening of mild cognitive impairment or mild dementia due to AD at sites across North America, Europe, and Asia Pacific.

Price Action: BIIB shares are trading lower by 2.26% to $246.41 on the last check Wednesday.