Alzheon Partners With Czech Institute of Organic Chemistry & Biochemistry To Develop Alzheimer’s Diagnostic Test

In full transparency, the following is a press release submitted to SOURCE media through its business wire service.

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FRAMINGHAM – Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, today, May 4, announced it has entered into a collaboration and license agreement with the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences (IOCB) to develop the first clinical assay to measure neurotoxic beta amyloid (amyloid, Aβ) oligomers in human cerebrospinal fluid (CSF).

Under the collaboration agreement, the Institute will apply Alzheon’s technology for detecting oligomers into a customized clinical assay in human CSF, to be developed by the Institute and commercialized by Alzheon. This initiative builds on successfully completed feasibility studies performed over the past year by the two organizations.

The assay developed by the Alzheon-IOCB collaboration will be sensitive to the full spectrum of soluble oligomer species in CSF and will be able to quantify the amyloid oligomer burden in the brain. The new diagnostic is designed to address the limitations of current assays used to detect amyloid oligomers, such as enzyme-linked immunosorbent assays, that can be sensitive to oligomer levels, but are non-specific, as they do not distinguish individual species of Aβ oligomers.

“In just the last year, we have seen clinical validation and consensus around the importance of targeting soluble amyloid oligomers to effectively treat Alzheimer’s patients, however, these oligomers are extremely challenging to track,” said Martin Tolar, MD, PhD, Alzheon Founder, President and Chief Executive Officer. “Working with IOCB, we will apply state-of-the-art analytical chemistry technologies to develop an assay that can provide a key missing piece of the puzzle – detecting and measuring neurotoxic amyloid oligomers, the underlying ‘fire in the brain’ that drives Alzheimer’s pathology. Such a tool is not only valuable as a diagnostic for patients with Alzheimer’s disease, but also offers a way to monitor response of patients to therapy. Using genetics-based precision medicine, we are advancing our oral tablet ALZ-801 into Phase 3, and in our studies, we will now have an opportunity to determine how reduction in oligomer toxicity correlates with clinical benefit.”

The collaboration between Alzheon and IOCB will leverage Alzheon’s discoveries and scientific expertise in AD, particularly the insights into the role of Aβ oligomers in disease biology. Alzheon will provide biospecimens from AD patients including samples from patients treated with ALZ-801. The IOCB will be primarily responsible for the development and validation of an assay to detect amyloid oligomers and to measure the change in amyloid levels in biological samples following treatment with Alzheon’s anti-oligomer agents, such as ALZ-801.

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“Beyond its diagnostic and theragnostic potential, this assay will provide researchers and clinicians with the ability to profile anti-amyloid antibodies and other Alzheimer’s drugs with different selectivity for amyloid oligomers relative to fibrils and plaque, which can improve therapeutic paradigms for patients,” said Prof. Ing. Martin Fusek, CSc., Vice–Director for Strategic Development of IOCB. “We are excited to enter this partnership with Alzheon, the market leader of small molecule anti-amyloid agents, in developing a novel approach to measuring the toxic products of amyloid aggregation. This new assay can have a far-reaching impact on Alzheimer’s research and treatment by illuminating new aspects of the disease mechanism and by informing interventions to stop or even prevent the disease process.”

Recent findings from AD studies and clinical trials provide strong evidence that soluble amyloid oligomers are directly neurotoxic upstream drivers of AD pathology, leading to progressive increase in phosphorylated tau protein and markers of neuronal injury in CSF and plasma of AD patients. Amyloid oligomers are a key target of several promising Phase 3 antibodies for Early AD including aducanumab, lecanemab/BAN2401 and donanemab, as well as Alzheon’s lead clinical candidate, ALZ-801, an oral treatment that fully blocks formation of neurotoxic oligomers in the brain at clinical dose.

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“We are excited to join forces with researchers from IOCB to develop a sensitive and specific assay that will enable us to track the levels of toxic amyloid fragments that have eluded detection in brains of Alzheimer’s patients. Such an assay will provide the opportunity for earlier diagnosis and better therapeutic treatments tailored to each patient, a precision medicine approach to Alzheimer’s disease that we have pioneered at Alzheon” said John Hey, PhD, Chief Scientific Officer of Alzheon. “This collaboration builds on the discovery of mechanism of action of ALZ-801 and numerous studies by Alzheon scientists, and leverages IOCB’s world-class expertise in analytical science and technologies. Combined with data from our ongoing Phase 2 study evaluating ALZ-801 effects on fluid and imaging biomarkers, this theragnostic will allow us to gain critical insights into the links between neurotoxic amyloid oligomers, disease progression, and response to treatment.”

An oral anti-amyloid drug, ALZ-801 is an optimized prodrug of tramiprosate that has shown promising results in analyses of Phase 3 clinical data,^6,8 and has a novel anti-amyloid oligomer mechanism of action. ALZ-801 received Fast Track designation from the U.S. Food and Drug Administration in 2017.

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Alzheon, Inc. is a Framingham-based company committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Its lead Alzheimer’s clinical candidate, ALZ-801, is an oral small molecule prodrug of tramiprosate that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. ALZ-801 is an easy-to-take tablet that builds on the safety and efficacy profile of its active compound tramiprosate, which has been evaluated in clinical trials involving over 2,000 Alzheimer’s patients.

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