Cardiol Therapeutics’ stock has dropped after its lead asset, CardiolRx, failed to meet its co-primary endpoints in a Phase II trial.
In the ARCHER trial (NCT05180240), while the cannabidiol (CBD)-based oral solution showed some improvement on extracellular volume (ECV) values after 12 weeks in patients with myocarditis, the change just missed being statistically significant with a p-value of 0.0538.
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The ECV reduction, while not statistically significant, was associated with improvements over placebo in multiple pre-specified cardiac magnetic resonance imaging (CMR) endpoints, including a significant reduction in left ventricular (LV) mass.
At the same 12-week timepoint, CardiolRx also failed to significantly improve global longitudinal strain (GLS) scores in patients with preserved LV function compared with placebo.
Investors appear spooked by the data, with the company’s stock on the Nasdaq exchange dropping by 20% from a 5 August close of $1.35 to a 6 August close of $1.07.
Despite this, Cardiol Therapeutics president and CEO David Elsley noted that the life sciences company was “delighted” by the trial’s results.
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By GlobalDataThe company has not yet confirmed if it will take CardiolRx to Phase III clinical trials for myocarditis, though the Phase III MAVERIC trial (NCT06708299) involving the therapy in recurrent pericarditis is currently ongoing, with the trial set to conclude in late 2026.
Elsley also stated that the company will now “integrate the findings from ARCHER into its broader clinical development strategy and business development initiatives,” which will back the continued advancement of CardiolRx and its subcutaneous CBD asset, CRD-38.
In a previous analysis conducted by GlobalData, parent company of Clinical Trials Arena, analysts found that Cardiol Therapeutics’ CB1 and CB2 agonist, CRD-38, could hold significant potential in the heart failure space due to its differing mechanism of action (MoA).
CBD’s future in pharma
Though CBD has been used as a natural remedy for thousands of years, pharma has evaluated the compound and its analogues’ efficacy in a range of indications – conducting trials in everything from depression to pain and seizure management.
According to a report from GlobalData, therapies targeting the cannabinoid receptors 1 and 2 (CB1 and CB2) were the most popular targets in preclinical studies in 2022, with 391 drugs working through this mechanism.
However, this surge in pipeline therapies is yet to translate into the market, with Jazz Pharmaceuticals’ subsidiary GW Pharmaceuticals’ Epidiolex (cannabidiol) being the only CBD-based drug to have received approval in the US.
The drug gained approval in June 2018 for the treatment of patients with seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).
According to GlobalData’s Intelligence Centre, Epidiolex is forecasted to hit blockbuster status in 2025, with 2031 sales forecast to reach $1.4bn – a marked increase from the $972m the drug made in 2024.
For any CBD-based pharmaceutical to experience commercial success, however, it must overcome significant regulatory hurdles, with some markets such as China and Japan banning scientific research involving the compound, as well as its use as a medical product.
It is a similar story in the countries across the Middle East, Asia and Africa, where strict laws on cannabinoid-based drug development and approval pose difficulties for widespread development and sales of this drug type.
In the UK, cannabis-based treatments can be very difficult to access, despite medical cannabis having been legalised in November 2018. Seven years on, patients, particularly children with severe epilepsy, are still forced to rely on costly private prescriptions or public fundraising efforts, with calls to increase research into therapies to improve access.
