VANCOUVER, Wash., June 11, 2026
CytoDyn Inc. announced that the first patient has been dosed in the Phase 2a SALIENT-AD clinical study, a proof-of-concept trial evaluating leronlimab in patients with early-stage, biomarker-confirmed Alzheimer’s disease. Conducted in collaboration with Weill Cornell Medicine, the study is designed to investigate the safety and biological activity of leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, which has emerged as a potential regulator of neuroinflammation and neurodegenerative disease progression. The milestone marks CytoDyn’s entry into Alzheimer’s disease research while continuing development of leronlimab across multiple therapeutic areas, including oncology. The trial will enroll approximately 10 to 20 patients aged over 50 years and evaluate the impact of weekly subcutaneous leronlimab administration over a 12-week treatment period.
SALIENT-AD Study Targets Neuroinflammation in Alzheimer’s Disease
The SALIENT-AD (Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer’s Disease) study is designed to assess whether targeting the CCR5 pathway can influence key biological mechanisms associated with Alzheimer’s disease. The primary endpoint focuses on measuring changes in brain inflammation and microglial activation using advanced positron emission tomography (PET) imaging. Secondary endpoints include evaluations of safety, tolerability, cognitive performance, blood-based biomarkers of neurodegeneration and inflammation, and assessments of blood-brain barrier integrity using MRI imaging technologies. Researchers believe chronic neuroinflammation plays a critical role in Alzheimer’s progression, making immune pathway modulation an increasingly important area of investigation. The study is being led by Dr. Tracy Butler, Associate Professor of Neurology in Radiology and Psychiatry and Medical Director of the Brain Health Imaging Institute at Weill Cornell Medicine.
CCR5 Blockade May Offer a Novel Therapeutic Approach
Emerging scientific evidence suggests that the CCR5 receptor influences multiple neurological processes, including immune cell signaling, microglial activity, synaptic plasticity, memory formation, vascular function, and blood-brain barrier stability. Alzheimer’s disease is increasingly recognized as a multifactorial disorder driven not only by amyloid-beta plaques and tau tangles but also by persistent immune dysregulation and inflammatory responses within the brain. By blocking CCR5 signaling, leronlimab may help reduce maladaptive neuroinflammatory activity while supporting neuronal function and resilience. Preclinical and translational studies have indicated that CCR5 modulation could potentially impact disease pathways associated with cognitive decline, making it an attractive target for therapeutic development in neurodegenerative disorders.
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CytoDyn Expands Clinical Development Beyond Oncology
While CytoDyn remains primarily focused on advancing leronlimab in oncology programs, including its ongoing CLOVER Phase 2 study in metastatic colorectal cancer (mCRC), the initiation of SALIENT-AD represents a strategic expansion into neurodegenerative disease research. The company views Alzheimer’s disease as a significant unmet medical need, with limited treatment options currently available to address disease progression. Positive findings from the Phase 2a study could provide important biological validation for CCR5-targeted therapies in neurological disorders and support further clinical development. As researchers continue to explore innovative approaches beyond traditional amyloid and tau targets, the SALIENT-AD trial may offer valuable insights into the role of immune modulation in Alzheimer’s disease and potentially open new pathways for therapeutic intervention.
Source: CytoDyn release
