Argent BioPharma to Supply Cannabinoid Treatment for Drug-Resistant Epilepsy in Slovenia

Argent BioPharma (ASX: RGT) has commenced the supply of a cannabinoid-based active pharmaceutical ingredient (API) to treat refractory (or drug-resistant) epilepsy patients at Slovenia’s largest hospital.

The API will be transitioned to routine use at the paediatric clinic within University Medical Centre Ljubljana (UMCL) following a successful pilot program, enabling neurologists to dispense recommended, protocol-aligned formulations for young patients.

CannEpil has previously demonstrated clinical utility in Ireland and other European markets, allowing Argent to refine dosing, safety monitoring, and supply logistics to accelerate regulatory alignment and physician uptake.

Multi-Year Collaboration

The supply agreement is the culmination of a multi-year collaboration between Argent and University Medical Centre, and Slovenia’s Ministry of Health and Agency for Medicinal Products and Medical Devices (JAZMP).

Argent has provided JAZMP with pre-clinical data and GMP validation, as well as clinical experience with its flagship CannEpil cannabinoid-based therapy, which helped shape the national framework permitting hospital compounding of cannabinoid formulations for neurological conditions.

Argent’s API is produced by EU-GMP-certified manufacturing partner PHCANN International, which is tasked with ensuring consistent, high-quality supply in line with European Pharmacopoeia standards.

Shaping Regulations

Chair Roby Zomer said the supply agreement validated Argent’s ability to convert pilot projects into full hospital programmes and highlighted its leadership in shaping cannabinoid regulations alongside national health authorities.

“Launching full clinical supply in Slovenia is a testament to our team’s regulatory expertise and our long-standing commitment to patients with refractory epilepsy,” he said.

“By partnering with University Medical Centre and leading clinicians, we are setting a new standard for cannabinoid-based neuroimmune therapies across Europe.”

‘Evidence-Based Option’

University Medical Centre senior consultant neurologist Dr David Neubauer was confident the API would advance the clinic’s work.

“Integrating a GMP-certified cannabinoid formulation supported by detailed protocols and a framework co-developed with Argent gives us an evidence-based option for the most complex epilepsy cases,” he said.

“We have developed strategies incorporating the API to treat the most resistant epilepsies and encephalopathies for children and adolescents, and our early results have been very encouraging.”