Harvest One Inc through its wholly-owned subsidiary Satipharm Ltd. (“Satipharm“), today announced positive results of a Phase 2 clinical trial of its CBD GelPell® capsules in the management of Treatment Resistant Epilepsy (TRE) have been published in Epilepsy & Behaviour, a bimonthly peer-reviewed medical journal covering behavioral aspects of epilepsy.
- Phase 2 open label clinical trial is aimed at measuring safety and efficacy of Satipharm CBD capsules for reducing seizure frequency in children with refractory, or treatment-resistant, epilepsy
- The median reduction of monthly seizures was -82% in the 12-week treatment period in treatment-resistant children when added to current medications
- 56% who started the treatment had a reduction of at least 50% in total number of seizures during the entire treatment period, compared to observation
- 73% were rated as “very much improved/improved” in overall condition on the Caregiver Global Impression of Improvement scale
- 82% were rated as “very much reduced/reduced”
- A mean 73.4% reduction from baseline monthly seizure frequencies was observed
- Two patients were fully seizure-free within 5 weeks of treatment
- An additional seven patients reported >50% seizure frequency reduction
A fulsome description of the study and results can be found in the Harvest One background document available on our website at https://www.harvestone.com/portfolio/satipharm/#clinical-trials
“The results of our second stage of clinical trials on our Satipharm 50mg CBD GelPell® products are very encouraging for the patients we serve, our shareholders and our company” said Grant Froese, Chief Executive Officer of Harvest One. “We continue to be focused on the best in class health, wellness, and self-care products at Harvest One and we believe that our unique products, including the proprietary GelPell®, will be highly sought after as cannabis legalization takes hold around the world”.
GelPell® capsules contain full spectrum hemp extract CBD in a seamless gelatine bead. This bead is placed inside a hard gastro-resistant capsule ensuring the release of CBD in the small intestine where it has the greatest effect. Manufactured in Switzerland and EU GMP Certified, every 50mg GelPell® capsule has been clinically proven to improve the body’s absorption of CBD and other cannabinoids. They are easy to take and contain a consistent and precise dose of CBD.
“The efficacy of Satipharm’s CBD capsules as an add-on therapy in the treatment of pediatric, intractable epilepsy has been shown. Moreover, these results compare favourably to other similar studies of cannabidiol” said Prof. Uri Kramer, Director of Pediatric Epilepsy Service, Tel Aviv Sourasky Medical Centre and Principal Investigator of the trial. “Importantly, the significant reductions in seizure frequency while demonstrating satisfactory safety and tolerability profile, in these very difficult to treat patients, have the potential to be a life-altering event for these patients and their families. I would be greatly interested in prescribing such standardized and clinically tested product as Satipharm’s 50mg CBD GelPell®“