Phase 2a study will evaluate the safety and biological activity of leronlimab in patients over the age of 50 with early-stage, biomarker-confirmed Alzheimer's disease
VANCOUVER, Washington, June 11, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple therapeutic indications, today announced that the first patient has been dosed in a Phase 2a clinical study evaluating leronlimab in patients with Alzheimer's disease, in collaboration with Weill Cornell Medicine.
The study, known as SALIENT-AD (Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer's Disease), is a Phase 2a, open-label, proof-of-concept study designed to evaluate the safety and biological activity of leronlimab in approximately 10 to 20 patients over the age of 50 with early-stage, biomarker-confirmed Alzheimer's disease. Patients will receive weekly subcutaneous injections of leronlimab over a 12-week treatment period. The primary endpoint will assess changes in brain inflammation and microglial activation using advanced PET imaging techniques. Secondary endpoints include safety and tolerability, cognitive assessments, blood-based biomarkers of inflammation and neurodegeneration, and measures of blood-brain barrier integrity using MRI. The study will be led by Tracy Butler, MD, Associate Professor of Neurology in Radiology and Psychiatry and Medical Director of the Brain Health Imaging Institute at Weill Cornell Medicine.
"This study is designed to evaluate whether modulation of CCR5 can meaningfully impact neuroinflammatory processes that are increasingly recognized as central to Alzheimer's disease," said Dr. Butler. "We are leveraging advanced imaging and biomarker tools to better understand how targeting immune signaling pathways may influence disease biology."
"While CytoDyn remains focused on developing leronlimab in oncology, and we are especially encouraged by the early readouts from our CLOVER Phase 2 study in patients with mCRC, the collaboration with Weill Cornell Medicine in the SALIENT-AD study represents an opportunity to explore potential patient benefit in an indication that represents a significant unmet need," said Jacob Lalezari, M.D., chief executive officer, CytoDyn.
Alzheimer's disease is a complex and multifactorial neurodegenerative condition characterized not only by amyloid-beta plaques and tau tangles, but also by chronic neuroinflammation, microglial activation, and disruption of the blood-brain barrier. Emerging research suggests that CCR5, a chemokine receptor expressed on immune cells, may play a central role in regulating these processes.
Preclinical and translational research suggests that CCR5 plays a role in synaptic plasticity, memory formation, and microglial signaling, and may influence processes such as autophagy, vascular health, and blood-brain barrier stability. By blocking CCR5, leronlimab may help reduce maladaptive immune signaling and support neuronal resilience.
About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients' quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.
For more information, please visit www.cytodyn.com and follow us on LinkedIn.
Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned "Forward-Looking Statements" and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.
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