Ananda Aiming to ‘Meet Regulators at Their Point of Need’ As it Secures More Major UK Clinical Cannabis Trials

Via Business of Cannabis

Last month, Business of Cannabis reported that two long-awaited NHS clinical trials to investigate the role of cannabis-based medicines in severe forms of epilepsy were now set to get underway, nearly six years after first being promised.

It was later revealed that Ananda Developments had won a competitive tender to participate in these landmark trials, which represent the largest investigational trials conducted into cannabis and refractory epilepsy.

These Phase III trials are the latest in a series of research projects set to be conducted in the UK and elsewhere with compounds developed by Ananda.

Ananda’s CEO Melissa Sturgess told Business of Cannabis: “Our approach has been to ask, ‘What are regulators like the MHRA and NICE asking for? How can we meet those requirements?’ … It’s about meeting regulators at their point of need, rather than debating how they should regulate the space.”

In October, Ananda announced that its patent-pending cannabinoid medicines, MRX2 (CBD) and MRX2T (CBD + THC), will be used in two Phase IIIa clinical trials, co-funded by the National Institute for Health and Care Research (NIHR) and the NHS.

The trials, set to be conducted by University College London (UCL) and Great Ormond Street Hospital (GOSH) aim to evaluate the safety and efficacy of these medicines for refractory epilepsy in children and adults

Involving up to 500 patients across multiple NHS sites, these are not only the largest trials of their kind globally but also the first major UK trials into this condition since GW Pharmaceuticals widely cited research.

Ms Sturgess explained: “As I understand it, these trials were first planned back in 2019 or 2020—a long time ago. They were initiated because the BPNA (British Paediatric Neurology Association) wanted to see more comprehensive data across a broader range of epilepsies before they felt comfortable recommending their specialists prescribe CBD-based drugs for conditions beyond Dravet Syndrome and Lennox-Gastaut Syndrome.

“A significant amount of time was spent finding a formulation that would meet the regulator’s requirements, which has been a major challenge. We were invited to tender to supply the drug for these trials and were fortunate to be successful.”

The two randomized controlled trials (RCTs) are designed to support potential regulatory approval for MRX2 and MRX2T:

Patients will be randomly assigned to receive MRX2, MRX2T, or a placebo over 24 weeks. These formulations, including a matched placebo, will be supplied by Ananda.

 

When these trials were first announced, experts and patient advocates in the UK warned that the trial design may not provide the solutions many were hoping for.

Specifically, Hannah Deacon and her colleague Professor Mike Barnes, one of the UK’s most experienced and respected private medical cannabis prescribers, highlighted concerns over the use of CBD isolate for these studies.

Professor Barnes explained that while ‘there is nothing wrong’ with using CBD isolate, which we know works well for epilepsy and is widely prescribed via drugs like Jazz Pharmaceuticals’ Epidyolex, it fails to take into account the benefits of full-spectrum products.

Asked about these concerns, Ms Sturgess emphasised that she didn’t see these trials ‘as being mutually exclusive with the full spectrum approach’, and that it was in now way ‘about diminishing the argument for full spectrum’.

“This approach makes sense from a practical standpoint. Trials of this nature require a focus on specific strains and formulations rather than attempting to address the broad spectrum of cannabinoids all at once. It’s the only realistic way to move forward and achieve meaningful progress,” she continued.

“And the only way you can get a very standardised product is to make it very specific. So you know, that is just the nature of the beast.”

Regarding the discussions and ‘extensive lobbying efforts’ around full spectrum products, she added that Ananda was ‘fully supportive of those efforts, even if its not the path we’ve chosen to take’.

“I think it’s important to keep advocating for those patients, especially those who are unable to stop their current medications. Their needs are real and urgent. But we also have to view these discussions as parallel rather than conflicting—it’s not an either-or situation. We’re all working toward the same goal: helping patients.”

Again, she emphasised her philosophy of working within the parameters of the regulators to move research forward, rather than working to change these parameters regardless of their suitability for cannabis.

“Regarding CBD, one of my least favorite phrases is, ‘We know CBD works.’ Because while we may believe it works, saying that to the regulator isn’t enough. We have to prove it in the way they require. That’s what we’re focused on—generating the evidence to meet their standards and show them it works.”

Another key concern raised was over the ‘washout period’ of eight weeks, meaning they are unable to take any cannabinoid medication during this time.

In response, Ms Sturgess pointed out the UCL ‘has very robust and thorough protocols for how participants are recruited’, and that the safety of participants was always the paramount concern.

“The trial wouldn’t get through ethics approval or any other regulatory hurdles if those issues weren’t addressed. Second, I understand that there are patients—likely children—on other medications, and there’s real concern about the washout period. In some cases, it may mean that these patients can’t participate in the trial. But that doesn’t mean we shouldn’t proceed with the trial as planned.”

These UK trials go beyond those conducted by GW Pharmaceuticals decades ago, in that they are focusing on a much broader range of epilepsies than its studies on Dravet Syndrome and Lennox-Gastaut Syndrome.

“There is widespread recognition of the huge therapeutic potential of CBD. The success GW achieved with its licensed drug for Dravet and Lennox-Gastaut demonstrates that potential. The current effort is about expanding the evidence base to give prescribers confidence to recommend CBD formulations for other types of epilepsy.

“In the UK, it is very difficult for specialists to prescribe off-label, especially for a drug that has been approved for an orphan indication. The goal here is to provide the necessary data to support CBD as a treatment for a broader range of epilepsies, which could significantly improve access for patients.”

These trials are just one of a number of clinical studies Ananda is conducting in an effort to expand useable data on CBD treatments.

In October, Ananda announced the launch of a Phase I clinical trial in Australia with its MRX1 compound, already set to be used in a number of Phase 2 clinical trials in the Scotland, following the company’s acquisition of MRX Medical Limited for £2m in March 2023.

This trial, according to Ms Sturgess, is focused on pharmacokinetics—essentially examining how CBD is absorbed into the bloodstream, how it’s dosed to maintain specific levels, and other considerations.

“In the unlicensed medical cannabis space, treatments are often quite personalised. However, when you move into more standardized pharmaceuticals, even with personalised dosing, there’s typically a clear understanding of how a particular dose behaves in terms of blood plasma levels. What we’re doing is collecting all that data for MX1 in a human study.”

This is in addition to the two RCT’s being conducted by the University of Edinburgh, which have already secured £1.55m in funding to explore its effectiveness in treating endometriosis-associated pain and CBD on chemotherapy-induced peripheral neuropathy.

Ananda and the university are currently ‘working through all the backend stability testing and regulatory pharmaceutical requirements’ that need to be completed before it can begin dosing humans.

“While there’s plenty of anecdotal and real-world data suggesting that CBD doesn’t degrade, we are required to demonstrate this for our specific formulation. This is a crucial step because if we successfully complete clinical trials and apply for a license with the MHRA, they will expect robust stability data as part of the regulatory submission.”