CannaLean Biotechs Announces Positive Completion of First-in-Human Feasibility Study of Its Novel CBD-Based Lipid-Lowering Therapy

TEL AVIV, Israel, Jan. 20, 2026 /PRNewswire/ -- CannaLean Biotechs Ltd., a clinical-stage biotechnology company developing a patented cannabidiol–chitosan (CBD–CHT) formulation for dyslipidemia, today announced the successful completion of its first-in-human feasibility study evaluating safety and early biological activity in adults with elevated LDL cholesterol(the 'bad' cholesterol).

CannaLean's proprietary oral formulation, CLC-01, is protected by a Composition of Matter patent granted in the United States, India, Korea, and Australia, with additional territories pending. The platform is based on a synergistic combination of cannabidiol (CBD) and chitosan, which has demonstrated superior lipid-lowering activity in multiple preclinical models compared to either component alone.

The feasibility study was conducted in collaboration with Clalit Health Services, Israel's largest healthcare organization, through its commercialization arm Mor Research Applications, a strategic shareholder of CannaLean. This partnership enabled execution within real-world clinical settings across Clalit's nationwide network of community clinics.

Study Highlights

Favorable Safety Profile

CLC-01 was well tolerated across all treated participants. No serious adverse events or clinically meaningful laboratory abnormalities were observed, and only mild, transient events were reported, supporting continued clinical development and dose optimization.

Encouraging Lipid-Lowering Signals

The efficacy conclusions of the study demonstrated consistent biological trends:

• Participants receiving CLC-01 showed a progressive reduction in LDL cholesterol during the 12-week treatment phase, followed by continued improvement during follow-up.
• By the end of the study period, mean LDL-C levels in treated participants declined by approximately 28%, compared with the observed in the control group.
• Total cholesterol followed a similar pattern, with sustained improvement in the treatment arm.

"These first-in-human results provide an important validation of our platform," said Professor Moshe Mittelman, MD, Chief Scientific Officer of CannaLean Biotechs Ltd. "The favorable safety profile and consistent lipid trends support advancing CLC-01 into larger, controlled clinical studies."

Addressing a Significant Market Need

Dyslipidemia affects hundreds of millions of individuals worldwide and remains a major driver of cardiovascular disease and mortality. While statins are widely prescribed, many patients do not achieve target lipid levels, experience tolerability issues or experience intense side effects. Existing non-statin therapies are effective but often limited by cost, injections, or accessibility.

CannaLean's oral CBD-based approach is designed to offer a safe, well-tolerated, and scalable alternative second line treatment suitable for broad global populations.

Regulatory and Market Tailwinds

Recent regulatory developments in the United States reflect growing acceptance of evidence-based cannabinoid-derived therapies, including progress toward federal cannabis reclassification and emerging public healthcare initiatives evaluating CBD-based treatments. These trends may support regulated clinical development pathways and broader adoption of clinically validated cannabinoid platforms.

Next Steps

CannaLean plans to advance CLC-01 into a larger, statistically powered clinical program to further evaluate efficacy and support a regulated pharmaceutical development path, while also informing parallel wellness-oriented commercialization opportunities.

About CannaLean Biotechs Ltd.

CannaLean Biotechs Ltd. is a clinical-stage biotechnology company advancing innovative CBD-based therapies for metabolic health, supported by strong intellectual property and a strategic partnership with Clalit Health Services.

For more information, visit: www.CannaLeanBio.com

Contact:
CannaLean Biotechs Ltd.
[email protected] 

SOURCE CannaLean Biotechs Ltd.