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.
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