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Alive and Kicking: Pot stock Argent Biopharma aims to raise bar on epilepsy treatment
Health & Biotech
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- Argent Biopharma plans further trials of its cannabinoid-based epilepsy treatment
- Argent’s early research work suggests “improved safety profile alongside enhanced efficacy.”
- The first patient in Dimerix’s pivotal kidney trial enters open-label extension stage
Alive and Kicking is renowned biotech journo Tim Boreham’s new daily wrap covering morning movers and shakers of note in the ASX Healthcare sector, Monday through Thursday.
Perth-based medical cannabis play Argent Biopharma (ASX:RGT) is confident of raising the bar on its potential treatment for epilepsy and seizures – about the only key indication for which medical pot has been approved by regulators.
But first, to advance its candidate CannEpil it has to fill the “knowledge gap” caused by a void of proper randomised-controlled trials in the out-of-favour sector.
“While the US Food and Drug Administration (FDA) has already approved the use of cannabidiol alone for treating seizures in a few rare conditions, CannEpil as a compounded formulation may offer additional advantages,” the company said in an update this morning.
The existing treatments avail of the cannabidiol CBD, an active ingredient in cannabis that is derived from the hemp plant (but unlike THC, does not cause a high).
Cannabis plants also contain around 100 cannabinoids, many of them with claimed therapeutic effects.
“Different combinations [of cannabinoids] have shown a synergistic effect in animal models of seizures, enabling improved control with significantly lower doses,” the company says.
“However, different cannabinoid combinations have not yet been thoroughly studied for the treatment of seizure disorders in well-controlled clinical trials.”
The company’s initial evidence is via special access programs locally and in Ireland, which enable patients to be treated with an unapproved drug.
Initial work suggests CannEpil can be prescribed at a 28-35% lower dose than the CBD-only drug it was compared with, “demonstrating its potent efficacy.”
The company says the next step is addressing the “preclinical and clinical gaps in knowledge and data”, in view of seeking marketing authorisation.
“These activities include completing the missing toxicology data through preclinical studies in the upcoming quarters,” the company says.
“This will be followed by initial clinical trials to establish the pharmacokinetics of CannEpil in humans [how the drug behaves in the body] and early phase efficacy trials.”
In the UK, Argent is collecting “real world” patient data to support its cause. In the US, the company has begun the process of seeking FDA approval to carry out a trial there.
The company adds that combined cannabinoid treatments have been “occasionally observed” to restore seizure control after the failure of pure CBD therapies.
“This opens the possibility that CannEpil might be effective in patients with treatment-resistant epilepsy who have failed treatment with CBD alone or other approved, conventional treatments.”
So far, the FDA has approved only Epidiolex as a CBD medicine although it has approved two THC-bearing drugs for chemotherapy-induced nausea.
Otherwise, the agency looks darkly on CBD because of potential liver damage, undesirable interactions with other medicine and even potential harm to male reproduction.
Known as MGC Pharmaceuticals until April this year, Argent has a long way to go. But if it can obviate these concerns, it may be on to something.
With $700,000 of cash as of June 30 this year, the company needs more bikkies in the tin to pursue its lofty ambitions.
Argent shares this morning fell 8% to 33 cents.
First patient ‘graduates’ from Dimerix kidney failure trial
Break out the mortar boards: it’s graduation time at Dimerix (ASX:DXB), with the first patient from its pivotal Action 3 kidney trial moving to open label extension (OLE) study stage.
Action 3 is aimed at securing regulatory approval for the company’s lead drug candidate, DMX-200 to treat focal segmental glomerulosclerosis (FGSC).
After treatment, all of the patients have the option of continuing treatment under the OLE stage for another two years.
Unlike with the main trial the data isn’t ‘blinded’, which means the patient and the trial investigators know the active drug – rather than a placebo – is being administered.
All qualifying OLE patients can receive DMX-200, including those administered a placebo during the main trial.
The patients also will continue on the standard-of-care treatment, such as blood pressure meds and angiotensin receptor blockers.
Given the usually lengthy period between trial completion and approval, the OLE mechanism enables patients who have responded well generally want to continue treatment.
So there’s a humanitarian element. Furthermore, the extended treatment generates more data to persuade the regulators.
FGSC is a rare disease that causes kidney failure and ultimately death, or a lifetime of dialysis. There is no current treatment.
The company hopes to release its second interim analysis of the Action 3 trial in mid-2025. To date, 166 patients have been dosed.
Dimerix shares lost 6% this morning to 38 cents.
At Stockhead, we tell it like it is. While Dimerix is a Stockhead advertiser, it did not sponsor this article.
