After Aducanumab was approved, the development of new drugs for Alzheimer's disease is surging

Text | Pickup Bay

On June 7, the FDA accelerated the approval of Biogen/Eisai’s Aβ (amyloid β) antibody Aduhelm (aducanumab) for the treatment of Alzheimer’s disease (AD) patients with a biological product license (BLA) based on the biomarker surrogate endpoint.

Biogen's stock price trend in the past 1 month

Bojian/Eisai AD antibody lecanemab obtained breakthrough therapy designation

On June 23, Bojian and Eisai jointly announced that the US FDA has granted the breakthrough therapy designation for the researching AD antibody therapy lecanemab (BAN2401)

Aβ exists in various forms, including monomers, oligomers, protofibrils, and insoluble fibers.

The award of breakthrough therapy designation is based on the results of the Phase IIb clinical trial Study 201

Eisai and Bojian have launched two phase III clinical trials to further test the efficacy of lecanemab

Eli Lilly’s AD new drug has been awarded FDA breakthrough therapy and plans to declare for marketing within this year

On June 24, the US FDA granted Eli Lilly’s research antibody drug donanemab a breakthrough therapy designation for AD

Donanemab is an antibody drug that targets N3pG-modified Aβ protein under development.

Based on TRAILBLAZER-ALZ research data, Eli Lilly plans to submit donanemab's BLA through an accelerated approval path later this year

Bristol-Myers Squibb acquires anti-tau antibody for AD drug for US$2.

A number of pre-clinical studies have proved that, compared with other anti-tau antibodies, PRX005 has shown superior ability in binding, intercepting and blocking the internalization of pathogenic tau cells and reducing downstream neurotoxicity

Simcere and Vivoryon reached a regional strategic cooperation on AD treatment drugs

On June 29, Simcere Pharmaceuticals announced that it has reached a strategic regional licensing cooperation with Vivoryon to develop and commercialize two AD drugs developed by Vivoryon in Greater China.

Varoglutamstat is an oral small molecule inhibitor of glutamyl peptide cyclase (QPCT)

PBD-C06 is a humanized, deimmunized IgG1 antibody drug in the pre-clinical development stage.

Roche seeks to submit a marketing application for the Aβ antibody gantenerumab to the FDA

On July 1, according to a report by investment bank Jefferies, Roche held a meeting with the FDA last week.

Roche's gantenerumab antibody failed a key trial in 2014 and another study on familial Alzheimer's disease in 2020, despite its success in reducing amyloid levels

Jefferies analyst Peter Welford said that in part because of the failure of these trials, they believe the drug has a 0% chance of being approved in their model
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If approved, sales are expected to reach a conservative peak of $3 billion
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Suoyuan Biotechnology introduced AD new drug Idalopirdine

On July 1, Suoyuan Biotech announced that it has obtained the global rights of Idalopirdine from Lundbeck, including the development, production and commercialization of all indications
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Ldalopirdine (now DB109) is an oral antagonist of 5-HT6 receptors
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This receptor is mainly expressed in areas of the brain involved in cognition and is presumably related to Alzheimer's disease, schizophrenia and other indications
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The inhibition of 5-HT6 receptor can increase cholinergic and glutamatergic nerve activity and improve cognitive function
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DB109 has been extensively evaluated in numerous clinical studies involving more than 2500 subjects
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Although the results of phase III clinical trials were negative, it has been determined to show preliminary efficacy in some patient subgroups
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In the past decade, precision medicine has proven to be critical to many breakthroughs in oncology drug development, and the lack of pharmacogenomic biomarkers may be one of the main reasons for the failure of Alzheimer's disease
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Suoyuan Bioplan uses its unique biomarker platform to find pharmacogenomic predictors of DB109 efficacy
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By using newly discovered biomarkers as companion diagnostics to screen patients, re-run clinical trials in sensitive patients, thereby optimizing efficacy, safety and tolerability, and increasing the success rate of new drug development
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Suoyuan Biotechnology Platform

GlaxoSmithKline acquires 2 first-in-class new drugs for neurodegenerative diseases for US$2.
2 billion

On July 2, GlaxoSmithKline (GSK) and Alector reached a global strategic cooperation to jointly develop and commercialize two potential first-in-class monoclonal antibodies AL001 and AL101 in the clinical stage for treatment Neurodegenerative diseases
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AL001 and AL101 are designed to increase the level of progranulin (PGRN) in patients
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PGRN is a key regulator of brain immune activity and has genetic links with a variety of neurodegenerative diseases
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Therefore, it is one of the most attractive genetic verification targets in the development of new immunoneurological therapies
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AL001 is currently undergoing a pivotal Phase III clinical trial for the treatment of patients who are at risk of frontotemporal dementia due to GRN gene mutations or who have frontotemporal dementia (FTD)
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In addition, AL001 is also undergoing a phase II clinical trial for the treatment of FTD patients with C9orf72 gene mutation (FTD-C9orf72)
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AL101 is intended to be developed to treat patients with more common neurodegenerative diseases, including Parkinson's disease and Alzheimer's disease, and is currently undergoing phase Ia clinical trials in healthy volunteers
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