Unlock the Brain's regenerative capacity
the brain can repair itself | we provide the signal
Unlock the Brain's regenerative capacity
the brain can repair itself | we provide the signal
Vision and Mission
At Alevian, our vision is that by precisely targeting biological mechanisms that promote repair and regeneration we can restore quality of life for patients with debilitating neurological and aging-related diseases. Our mission is to develop innovative biologics that activate the body’s intrinsic repair systems to reverse the damage caused by injury, chronic disease, and aging. We are focused on proteins and pathways with well-established regenerative benefits, translating decades of foundational research, including pioneering work from our Harvard scientific advisors by specifically targeting GDF11, a developmental signal that has been demonstrated to unlock the body’s regenerative potential across neurologic, inflammatory, and aging-related diseases.
Our Approach
Alevian is pioneering a new class of regenerative therapeutics designed to modulate the molecular cascades activated in the critical hours, days, and weeks following neurological and systemic injury. Unlike traditional approaches that focus solely on restoring blood flow or providing nonspecific protection, Alevian’s platform targets the precise signaling events that drive tissue damage and limit recovery—therapeutic windows that remain largely untapped.
Central to this strategy is our work on the GDF11 signaling pathway and its downstream effectors, which regulate cellular stress responses, inflammatory signaling, vascular remodeling, and regenerative capacity across multiple tissues. By intervening at these key molecular nodes, Alevian’s therapeutics are designed to interrupt the cascades that account for much of the lasting damage observed after ischemic and traumatic events.
This mechanism-driven approach has yielded a robust therapeutic program – acute ischemic stroke, chronic ischemic stroke, intracerebral hemorrhage, traumatic brain injury, and metabolic disease - each tailored to the distinct pathophysiology of its target indication while leveraging a shared understanding of injury-driven and age-related biology. Together, these programs reflect a unified strategy to restore repair mechanisms that decline with disease, inflammation, and age, with relevance to neurological disorders, broader cardiovascular diseases, and metabolic disease.
THERAPEUTIC PIPELINE
Every year, millions of patients survive stroke and traumatic brain injury only to face permanent disability—not because their tissue cannot heal, but because the biological pathways that drive repair become impaired after injury and decline with age. There are currently no FDA-approved therapies that restore function after neurological damage.
One Platform. Multiple High-Value Indications.
ALE-001's multi-mechanistic profile enables us to efficiently pursue several indications with significant unmet need:
- Acute Ischemic Stroke — Entering Phase I Clinical Trials: Our most advanced program targets the subacute phase of stroke recovery, where no approved therapies exist. ALE-001 is progressing toward first-in-human studies, representing a potential first-mover opportunity in post-stroke neurorepair.
- Intracerebral Hemorrhage — Mid-Stage Preclinical: Hemorrhagic stroke carries even higher mortality and disability rates than ischemic stroke. ALE-001's anti-inflammatory and vascular-repair properties position it to address secondary injury cascades that drive long-term damage.
- Chronic Ischemic Stroke — Discovery: Millions of stroke survivors live with long-term disability, with no approved therapies to restore brain function months to years after injury. Although in discovery, ALE-001’s anti-inflammatory, neurogenic, angiogenic, and stem-cell–driven repair mechanisms are well suited to drive recovery in chronic stroke.
- Traumatic Brain Injury — Mid-Stage Preclinical: With over 2 million U.S. cases annually and no disease-modifying treatments available, TBI represents a substantial opportunity for ALE-001's regenerative approach across both focal and diffuse injury.
- Metabolic & Age-Related Disease — Discovery: We are expanding our platform into additional indications driven by chronic inflammation, vascular decline, and impaired tissue maintenance—extending the reach of our regenerative biology approach.
A Platform Built on Regenerative Science
- Our programs harness GDF11, a naturally occurring growth factor in the TGF-β superfamily that orchestrates the body's repair response. GDF11 regulates inflammation, promotes vascular remodeling, activates stem cells, and supports neurogenesis—the essential processes that determine whether damaged tissue degenerates or recovers.
- ALE-001, our lead therapeutic candidate, is an engineered recombinant form of GDF11 designed to reactivate these repair mechanisms when patients need them most: after injury, when the window for conventional intervention has closed.
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