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Clinical Trials

Phase 1 Clinical Trials - “Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology”

In March 2016, our phase 1 clinical study was completed which highlighted the considerably higher bioavailability of CBD when administered via Satipharm's CBD Gelpell® capsules in comparison to an oromucosal formulation in humans. These results are now published in Clinical Pharmacology in Drug Development (“CPDD”), an international peer-reviewed medical journal: Click here to read Phase 1 results.

Bioavailability

* 30% higher total bioavailability over 24 hours compared to an oromucosal spray
* At peak levels Satipharm CBD Gelpell® capsules have a 70% higher concentration in the body (Mean Maximum Concentration) compared to an oromucosal spray

Higher Stability

* We have over two years of stability data proving that the Gelpell® three dimensional natural gelatine matrix stabilises the CBD, inhibiting degradation

Satipharm Gelpell image

Phase 2 Clinical Trials

In July 2018, we completed our phase 2 clinical study to test Satipharm’s proprietary CBD Gelpell® capsules in sixteen paediatric patients with very severe, uncontrolled, treatment-resistant epilepsy.  This prospective, open-label study demonstrated a marked therapeutic effect of a 12-week treatment period on seizure frequencies among the trial patients.

A mean 73.4% reduction from baseline monthly seizure frequencies was observed, with two patients fully seizure-free within 5 weeks of treatment, while an additional seven patients reported >50% seizure frequency reduction.

This result was achieved with a safe product that does not contain the psychoactive cannabinoid THC.  This is an important consideration for a treatment where patients may need to take the treatment for some months or years.

For a fulsome description of the study and results please see the background Document below:
Phase II Clinical Trial Background Information

The Phase 2 clinical trial has been published in Epilepsy & Behaviour, a bimonthly peer-reviewed medical journal covering behavioral aspects of epilepsy.
Find full details of the Clinical Trial results here:
https://authors.elsevier.com/sd/article/S1525505019303051

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