MMJ PhytoTech reports early results in Phase 2 epilepsy trial

MMJ Phytotech ASX MMJ Satipharm CBD epilepsy trial Phase 2
Satipharm's CBD capsules.

The reintroduction of medical cannabis into treating illness and disease has received a boost, courtesy of clinical trials being conducted by MMJ PhytoTech (ASX: MMJ).

In an update to shareholders, MMJ has published an update regarding the ongoing Phase 2 clinical trial of its Satipharm CBD capsules. From the results made available today, Satipharm capsules “significantly reduce monthly seizure frequency when added to current medications with strong evidence of efficacy reported,” according to MMJ.

MMJ says that “median reduction of symptoms was -79.5% in the 12-week treatment period compared to the 4-week observation period”, although with that being said, MMJ’s sample size is limited which effectively means it cannot draw definitive conclusions from this clinical trial.

Test results in detail

The Phase 2 trial is an open-label, single-centre clinical study, designed to evaluate the safety, tolerability and efficacy of the Satipharm CBD capsules as an adjunctive treatment to 15 children (aged 2-15) with treatment-resistant epilepsy.

The study is comprised of 3 periods: observation (4 weeks), dose-titration and treatment (12 weeks), and follow-up (2 weeks). Eligible patients were selected on the basis of whether they had failed to respond to anti-epileptic drugs previously in order to best highlight Satipharm’s efficacy. The study exposed patients to daily doses of 25mg/kg or 450mg, with treatment being “generally safe and well tolerated with no serious adverse events observed.”

MMJ says that out of a total of 1,329 administrations of MMJ’s capsules, only 20 (1.5%) reported any adverse events. From the adverse events that were reported, “most were mild, a few were moderate, and all transient,” according to MMJ.

Eight patients completed the study, while two patients were discontinued due to worsening seizures. Following 12 weeks of treatment, 6 of the 8 patients were rated as “very much improved/improved” in overall condition on the Caregiver Global Impression of Improvement scale and 7 patients were rated as “very much reduced/reduced” on the Caregiver Global Impression of Seizures Severity scale.

“Notwithstanding the small number of patients treated to date, these results compare very favourably to other similar studies of cannabidiol, including those published by GW Pharmaceuticals,” said MMJ Phytech Managing Director, Andreas Gedeon.

“Importantly, these stark reductions in the number of seizures, in these very difficult to treat patients, have the potential to be a life-altering event for these patients and their families.”

“The completion of this Phase 2 clinical trial, which has been earmarked for the middle of 2018, is a major step towards the commercial development of our Satipharm CBD capsules and we look forward to providing further updates on progress in due course,” he added.

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