California-based cannabinoid science expert Emerald Health Pharmaceuticals has recently announced that it has successfully completed its 1st Phase I in-human clinical study to assess the pharmacokinetics, safety and pharmacodynamics and tentative biomarkers of EHP-101, the leading product candidate which is an oral formulation of a patented cannabinoid (CBD)-derived NCE (new chemical entity).
The aim of the Phase I trial was to facilitate the Phase II trials evaluating the effectiveness and safety of the EHP-101 in treating patients having Multiple Sclerosis (MS) and Systemic Scleroderma (SSc).
Phase II startup activities are ongoing for the testing of EHP-101 in MS and SSc treatment. Initiation of the first study for Phase II is expected before the end of the year.
104 healthy participants were a part of the Phase I clinical trial conducted as a double-blind, randomized placebo-controlled study which included 2 regimens – 8 SAD (single ascending dose) groups and 4 MAD (multiple ascending dose) groups, with increasing dosage in every group.
In the SAD study, each group was orally administered single doses of EHP-101 or placebo, ranging from 0.9 mg to 185mg in the lowest and highest dose group, respectively.
In the MAD study, each group received multiple oral doses of EHP-101 (once or twice in a day for 7 days), increasing from 20mg per day for seven days to 100mg per day for seven days in the lowest and highest dose groups respectively.
Aside from a few adverse experiences (mild to moderate levels) observed with increase in dosage, the EHP-101 was generally tolerated well.
Joachim Schupp, MD & Chief Medical Officer of EHP reportedly commented on the success, speaking on behalf of the EHP team and thanking all the members of the study team for their contribution towards evaluating EHP-101 in humans for future medical developments to target currently unmet remedial needs.
Phase I results are expected by end of 2019, once data analysis is fully completed.