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Replies to post #202772 on Anavex Life Sciences Corp (AVXL)
New research from Eisai showed measurable correlations between amyloid biomarkers in the bloodstream and changes in the cerebrospinal fluid, bringing the company a step closer to developing a quick and simple blood test for Alzheimer’s disease.
The automated immunoassay system, being developed with the Kobe, Japan-based Sysmex for its HISCL line of analyzers, aims to deliver results in under 20 minutes using microliters of blood.
The protein test quantifies the ratio between amyloid beta peptide chains of different lengths—in this case, the prevalence of chains with 42 amino acids, compared to those with 40. Both chains can clump up to form the toxic plaques that injure nerve cells within the brain.
The latter, known as amyloid beta 1-40, is more common, and its levels in CSF do not significantly change with the progression of Alzheimer’s disease, according to Eisai—however, reductions in amyloid beta 1-42 are seen in the disorder’s early stages.
To look for a similar link in the blood, the companies took both plasma and CSF from healthy elderly patients and those with mild cognitive impairment. A strong correlation was found between the ratios seen in both samples. Eisai and Sysmex exhibited the results in a poster presentation at the Alzheimer's Association International Conference in Los Angeles.
As a next step, the companies plan to further assess the immunoassay’s clinical utility by checking for correlations between blood-based amyloid beta ratios and PET scans.
Earlier this month, Eisai opened its new center in Cambridge, Massachusetts, to explore the genetic relationships between various dementias and potential immunotherapies, as the Japanese pharma looks to move its Alzheimer’s disease pipeline away from amyloid beta and tau—at least as a target for therapeutic drugs—following clinical trial failures.
Instead, the center will pursue a new class of “immunodementia” drugs, employing genomics research, data science and precision chemistry, as well as the company’s first startup incubator.
Eisai has put Michael Irizarry in charge of its Alzheimer’s disease clinical development programs. The ex-Eli Lilly and GlaxoSmithKline researcher is taking on the role in the wake of aducanumab’s failure.
Some companies may have responded to the failure of aducanumab to pass a phase 3 interim futility test by retreating from the expensive, high-risk world of Alzheimer’s R&D. For better or worse, there is little evidence that Eisai is such a company.
The day after disclosing the failure of the Biogen-partnered aducanumab, Eisai revealed it had moved another beta-amyloid drug, BAN2401, into phase 3. And the Japanese drugmaker has now bolstered its Alzheimer’s team by hiring one person to handle clinical development and a second to support medical strategies and post-approval studies.
Irizarry is handling clinical development. Eisai hired Irizarry as vice president of clinical research for its epilepsy and sleep/wake therapeutic groups last year, but is now moving him across to the Alzheimer’s team, where he will take responsibility for clinical development and overall strategy of Eisai’s portfolio of drugs aimed at the challenging neurodegenerative disorder.
There is some overlap between Irizarry’s old and new briefs. Specifically, Eisai has run phase 2 trials of dual orexin receptor antagonist E2006, also known as lemborexant, in irregular sleep-wake rhythm disorder in patients with mild-to-moderate Alzheimer’s disease. Eisai bought Purdue Pharma’s stake in the drug earlier this week.
Eisai unveiled the transfer of Irizarry to the new role alongside news of the appointment of Harald Hampel as VP, global medical affairs, Alzheimer's. The appointment puts Hampel in charge of coming up with Eisai’s global medical strategies in Alzheimer's and dementia. And he'll oversee phase 3b and 4 clinical trials of Alzheimer’s drugs, if one makes it that far.
Hampel has spent his career working outside of industry, most recently as a professor at Sorbonne University in Paris. Earlier in his career, Hampel was founding director of the Alzheimer Memorial Center at the University of Munich.
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