Biogen Stock Soars Following U-turn with their Alzheimer Drug Plans

By Rajaneesh K. Gopinath, Ph.D.

Last March, Biogen and its partner Eisai had announced their decision to discontinue a couple of late stage clinical trials of aducanumab, an investigational human monoclonal antibody. In a sudden turn of events, this morning they revealed new plans to pursue regulatory approval for the drug as an early Alzheimer’s disease treatment, sending its stock value into an upward surge.

Alzheimer’s disease (AD) is an age-related, progressive neurodegenerative disorder that leads to dementia in 80% of all cases. It is characterized by a number of phenotypic outcomes such as aggregation of amyloid beta (Aβ) peptides into plaques and the formation of Tau protein containing neurofibrillary tangles which ultimately leads to neurodegeneration. Although hundreds of drugs are being tested in clinical trials, an efficient cure is still elusive to the Alzheimer’s community. At present, there is no approved treatment that could reverse the clinical decline in AD patients.

In 2014, Biogen and Eisai entered a collaboration to develop and commercialize two of the latter’s clinical candidates E2609 and BAN2401 for the treatment of AD. Three years later, the collaboration was extended to aducanumab (BIIB037), a human monoclonal antibody derived from a de-identified library of B cells collected using Reverse Translational Medicine (RTM) technology platform. By specifically targeting Aβ aggregation, aducanumab was shown to enter the brain and reduce soluble and insoluble Aβ in a dose-dependent manner in both mice models and patients with mild AD. It met the primary endpoints in the preliminary trials, the data of which the companies presented at the Alzheimer’s Association International Conference back in February.

In what could be called a disaster, earlier this year, both companies announced their decision to end two ongoing trials of the drug following a futility analysis conducted by an independent data monitoring committee. The two-Phase III trials, ENGAGE, and EMERGE were designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to AD and mild AD dementia. This led to the company incurring losses and contemplate acquisitions to deal with it.

However, in a surprise U-turn, today they announced that after consultation with the USFDA, they are reviving plans to pursue the regulatory approval for aducanumab. New analyses show that the drug met its primary endpoint in the EMERGE study by showing “a significant reduction in clinical decline”, with improvements in cognition and function such as memory, orientation, and language. Besides, a subset of patients from the ENGAGE study who received higher exposure to the drug support their findings from EMERGE. If approved, this would become the first therapy to show that efficient removal of Aβ could lead to a reversal of clinical decline, a validation of the amyloid-beta hypothesis. In response to the news, the stock value of Biogen soared so much, that it almost recovered the losses that it suffered earlier this year.

“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid-beta.”

References

1. http://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease
2. http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-discontinue-phase-3-engage-and-emerge-trials
3. https://www.eisai.com/news/news201410.html
4. https://www.eisai.com/news/news201760.html

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Author

Rajaneesh K. Gopinath