Results of a Phase 1 clinical trial in healthy volunteers show that PTL101, an oral cannabidiol compound, is a safe and effectively delivered potential treatment of spasticity in multiple sclerosis (MS) and for conditions like epilepsy, Harvest One Cannabis announced.

These findings were published in the journal Clinical Pharmacology in Drug Development, in the study “Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology.”

The primary goal of the Phase 1 study (NCT03201835) was to evaluate the safety, pharmacokinetics (how a drug is absorbed, distributed and expelled) and tolerability of PTL101 capsules as a single administration of 10 or 100 mg of cannabidiol (CBD). Effects were compared to Sativex oromucosal spray — a therapy approved across Europe to treat MS-associated spasticity — that is also based on compounds from the cannabis plant, namely CBD and cannabinoids delta-9-tetrahydrocannabinol (THC). Sativex is produced by GW Pharmaceuticals.

A secondary objective was to compare the pharmacokinetic (how a drug is absorbed, distributed, metabolized and expelled) profile of THC, THC metabolite 11-hydroxy-THC and/or CBD following a single administration.

CBD is the main non-psychoactive component of the cannabis plant, and it has been associated with neuroprotective, anti-inflammatory, antiseizure, anxiolytic, antidepressant, and antipsychotic effects, Harvest One reported in a press release.

The trial was conducted by PhytoTech Therapeutics (PTL) in Israel using Satipharm’s proprietary GelpellR technology, a delivery system used to create PTL101 beads containing organically derived and pharmaceutical-grade CBD. Satipharm is a wholly owned Swiss subsidiary of Harvest One. 

Results demonstrated the treatment’s safety and high performance, including the effective delivery of CBD. The trial also showed that PTL101 capsules had a favorable bioavailability (the fraction of an administered dose that circulates system-wide) when compared to Sativex. 

A Phase 2 clinical trial (NCT02987114), also taking place in Israel, is now evaluating the efficacy of PTL101 capsules in treating pediatric refractory epilepsy.  It is expected to conclude in December.

A possible Phase 2 clinical trial assessing PTL101’s safety and efficacy in treating spasticity-related symptoms in MS patients is in the planning stages.

Several studies have reported that cannabis-derived therapeutic products can be of benefit to patients with MS and other conditions.

One conducted by the National Academies of Sciences, Engineering, and Medicine and published in the National Academies Press highlighted that certain cannabinoids can reduce spasticity symptoms in MS patients. It is titled “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research.”

This report, however, stressed that more research is needed to better understand the benefits and side effects of medical cannabis and cannabinoids.

• Author Details

Patricia Silva, PhD

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Patricia Silva, PhD

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.