What is the current state of progress in the fight against Alzheimer's disease?
The battle against Alzheimer's disease has reached a pivotal moment.
With over two decades of concerted efforts by academics and industry leading to the introduction of the first disease-modifying treatments, with the first traditional FDA approval granted to Eisai and Biogen’s Leqembi and another promising candidate from Lilly currently under review. These developments signal a hopeful trajectory in targeting amyloid beta (Aβ), by definition a pathological hallmark of the disease. Acumen aims to build on this progress with an increasingly targeted next-generation treatment approach that can potentially offer improved safety and efficacy compared with existing options. The shift toward disease-modifying treatments that offer tangible clinical benefits has also begun to alleviate the stigma associated with Alzheimer's diagnosis. We’re also seeing biomarkers playing an increasingly important role in the personalized treatment of the disease.
What unique approach is Acumen taking with its Alzheimer's treatment, sabirnetug?
Acumen's approach with sabirnetug (ACU193) centers on selectively targeting soluble amyloid beta-oligomers (AβOs), a form of Aβ that is believed to be particularly toxic to brain cells, especially when compared to Aβ monomers or deposited amyloid plaques. Sabirnetug’s selectivity for toxic AβOs is intended to offer potential advantages over other therapies by reducing side effects like brain swelling (edema) associated with plaque clearance, and protecting synapses which may lead to improved efficacy. Sabirnetug’s development encapsulates a journey from foundational scientific research through a partnership with Merck for further drug characterization, culminating in a promising candidate that leverages Acumen’s depth of expertise in Alzheimer’s drug development.
What do the fast-track designation and phase one trial results imply for sabirnetug’s future?
The FDA fast-track designation granted to sabirnetug underscores the FDA’s acknowledgment of the drug’s potential to fulfill an unmet need in Alzheimer’s treatment. Phase 1 trial results from INTERCEPT-AD were very promising, particularly in establishing sabirnetug’s safety profile and its ability to bind nearly all AβOs in the brain as intended. The results also demonstrated improvements across downstream tau and amyloid cerebrospinal fluid biomarkers, and remarkably, also in synaptic biomarkers, suggesting sabirnetug's target engagement of neurotoxic AβOs may protect synapses. These findings lay a robust foundation for further development. A subsequent study aimed at confirming sabirnetug's potential to be a safer and more efficacious treatment option for early Alzheimer's patients is expected to initiate in the first half of 2024.
What potential future developments could we see in Alzheimer's treatment?
The trajectory of Alzheimer's treatment is moving towards more refined therapies and the exploration of combination treatments that might include anti-Aβ agents alongside anti-inflammatory or tau-modulating agents. This evolving strategy, driven by advances in biomarker analysis, aims to provide more comprehensive benefits over existing therapeutic options.
While a cure for Alzheimer's is the ultimate goal, early intervention strategies, particularly for early and preclinical stages of the disease, hold promise for significantly delaying the onset of clinical symptoms or even preventing disease progression.
What lifestyle interventions can individuals adopt to potentially delay or prevent Alzheimer's?
Lifestyle choices play a role in mitigating the risk of Alzheimer's, with evidence suggesting benefits from a Mediterranean diet, regular exercise, and maintaining overall cardiovascular health. As diagnostic capabilities improve, including the advent of blood and genetic tests, individuals are increasingly empowered to take proactive steps in managing their health to potentially delay or prevent the onset of Alzheimer's symptoms.
How is Acumen positioned financially for the commercialization of sabirnetug?
With significant financial resources at its disposal, Acumen is strategically positioned to advance the development of sabirnetug through a phase two clinical trial to explore its clinical benefits and further establish differentiation from approved disease-modifying therapies or those in development. The company envisions eventually partnering for commercialization, although the timing and structure of such partnerships remain open. Acumen's current focus is on leveraging its capital and Alzheimer's drug development expertise to independently progress sabirnetug's clinical development.
What virtues are essential in the continued fight against Alzheimer's?
Perseverance stands out as a critical virtue in the complex and challenging fight against Alzheimer's. This determination, aligned with Acumen's core values of innovation, people, integrity, and perseverance, exemplifies the broader industry's resolve to overcome obstacles and achieve meaningful breakthroughs in Alzheimer's treatment. With a dedicated team and a strategic focus on impactful scientific approaches, Acumen is committed to helping drive the evolution of Alzheimer's care and management.
