Can-Fite BioPharma's experimental drug Piclidenoson has demonstrated efficacy in restoring tissue integrity and behavioral function in a preclinical vascular dementia model, according to a breakthrough study conducted by researchers at UCLA. The findings represent a potential therapeutic advance for a condition that affects millions worldwide and currently has no FDA-approved treatments.
UCLA Research Demonstrates Neuroprotective Effects
The study, headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professor and Chair Frances Stark Chair in the Department of Neurology at UCLA's Geffen School of Medicine, utilized a sophisticated vascular dementia mouse model with focal ischemia. This experimental design replicated many elements of the complex pathophysiology observed in human vascular dementia, providing a clinically relevant testing platform for the investigational therapy.
Piclidenoson was found to restore both tissue integrity and behavioral function in the vascular dementia model, suggesting potential neuroprotective and functional recovery benefits that could translate to human patients.
Addressing a Critical Unmet Medical Need
Vascular dementia represents the second most common cause of dementia after Alzheimer's disease, resulting from impaired blood flow to the brain often due to stroke or chronic small vessel disease. The condition presents a significant therapeutic challenge, as there are currently no U.S. FDA approved therapies specifically designed to treat vascular dementia.
Current treatment approaches rely on off-label use of medications including donepezil or memantine, which are used symptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are employed to prevent further vascular damage, but none of these medications are disease-modifying therapies that address the underlying pathophysiology.
Market Opportunity and Clinical Potential
The global market for vascular dementia is estimated at $6 billion as of 2025, with an expected compound annual growth rate of 5% through 2035, driven by an aging population and increasing diagnosis rates.
"A first-in-class agent such as Piclidenoson that could provide neuroprotection and improve vascular health would fill a significant unmet need and likely capture a large share of the growing Vascular Dementia market," stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma.
Drug Profile and Safety Experience
Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist that has demonstrated a compelling safety profile in hundreds of patients with psoriasis. The compound has shown anti-inflammatory activity in Phase 2 and Phase 3 clinical studies, recently reporting topline results in a Phase 3 trial for psoriasis and commencing a pivotal Phase 3 trial.
The drug's mechanism of action through A3 adenosine receptor modulation represents a novel therapeutic approach that could potentially address both the vascular and neurological components of vascular dementia pathology.
Company Pipeline and Development Strategy
Can-Fite BioPharma maintains a diversified pipeline targeting multi-billion dollar markets in cancer, liver, and inflammatory diseases. Beyond Piclidenoson, the company's portfolio includes Namodenoson, currently being evaluated in Phase III trials for hepatocellular carcinoma and Phase 2b trials for MASH treatment. Namodenoson has received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation for second-line HCC treatment.
The company's drugs have demonstrated an excellent safety profile with experience in over 1,600 patients across clinical studies to date, providing a foundation for continued development across multiple therapeutic areas.
