CannaLean Biotechs Ltd., a clinical-stage biotechnology company, announced the successful completion of its first-in-human feasibility study evaluating CLC-01, a patented oral cannabidiol–chitosan formulation for dyslipidemia.
The study assessed safety and early biological activity in adults with elevated LDL cholesterol.
About CLC-01
CLC-01 is CannaLean’s proprietary CBD–chitosan (CBD–CHT) oral formulation, protected by Composition of Matter patents granted in:
- United States
- India
- South Korea
- Australia
Additional territories are pending.
The formulation combines cannabidiol (CBD) with chitosan, showing superior lipid-lowering activity versus either component alone in multiple preclinical models.
Study execution and collaboration
The feasibility study was conducted in partnership with Clalit Health Services, Israel’s largest healthcare organization.
The trial was executed through Mor Research Applications, Clalit’s commercialization arm and a strategic shareholder in CannaLean.
This collaboration enabled study execution across real-world community clinic settings within Clalit’s nationwide healthcare network.
Study Highlights
Favorable safety profile
CLC-01 was well tolerated across all treated participants. Key safety observations:
- No serious adverse events reported
- No clinically meaningful laboratory abnormalities
- Only mild, transient side effects observed
The results support continued dose optimization and clinical development.
Encouraging lipid-lowering signals
The study showed consistent biological trends favoring CLC-01. Key efficacy observations:
- Progressive LDL cholesterol reduction during the 12-week treatment phase
- Continued LDL improvement during the follow-up period
- ~28% mean reduction in LDL-C by study end compared with controls
- Total cholesterol levels showed sustained improvement in treated participants
“These first-in-human results validate our platform,” said Prof. Moshe Mittelman, MD, Chief Scientific Officer of CannaLean.
“The safety profile and lipid trends support advancing CLC-01 into larger controlled studies.”
Addressing an unmet dyslipidemia need
Dyslipidemia affects hundreds of millions globally and is a major driver of cardiovascular disease.
Limitations of current treatments include:
- Incomplete LDL control with statins
- Tolerability and side-effect concerns
- High cost or injectable formats for non-statin therapies
CannaLean’s oral CBD-based approach aims to provide a safe, scalable, second-line option suitable for broad patient populations.
Regulatory and market tailwinds
Regulatory momentum in the United States reflects growing acceptance of evidence-based cannabinoid therapies. Key trends include:
- Progress toward federal cannabis reclassification
- Public healthcare initiatives evaluating CBD-based treatments
These developments may support regulated clinical pathways for validated cannabinoid platforms.
Next steps
CannaLean plans to advance CLC-01 into a larger, statistically powered clinical program to:
- Confirm efficacy
- Support pharmaceutical regulatory development
- Inform parallel wellness-focused commercialization strategies
About CannaLean Biotechs Ltd.
CannaLean Biotechs Ltd. is a clinical-stage biotechnology company developing CBD-based therapies for metabolic health, supported by strong intellectual property and a strategic partnership with Clalit Health Services.
