Ananda Pharma, one of many UK’s main clinical-stage pharmaceutical hashish firms, has introduced a string of strategic pivots, together with stepping away from a flagship UK medical trial into epilepsy.
After practically 4 years, it has additionally introduced plans to exit the ACQUIS inventory trade, whereas doubling down on its lead asset, MRX1, for ache remedy in endometriosis and chemotherapy-induced peripheral neuropathy.
It marks the newest instance of a hashish biotech firm being pressured to pivot within the face of adversarial circumstances, including to the rising exodus of promising early-stage firms from public markets.
Authorities-funded epilepsy trial breaks down
On 26 September, Ananda introduced that it had terminated its relationship with the contractor that had been supplying MRX2 and MRX2T formulations for epilepsy research at College School London (UCL) and Nice Ormond Avenue Hospital (GOSH).
Ananda confirmed it had acquired formal notification from UCL that it was now not concerned within the research, and that the contractor had been unable to fulfil its obligations below its settlement with UCL/GOSH. Whereas Ananda is now not concerned, the trials are anticipated to be continued and an ‘various provider’ is now being sought.
The trials have been introduced to appreciable fanfare in October 2024, following years of guarantees from a number of governments and false begins.
As just lately as final week, these trials have been referenced by members in Parliament in response to requires higher motion on medical hashish.
In February 2024, the Nationwide Institute for Well being and Care Analysis (NIHR) confirmed to The Pharmaceutical Journal that no publicly-funded medical hashish trials had but produced an final result.
The 2 epilepsy trials that may finally choose Ananda as a provider have been described as ‘nonetheless below operational consideration’ however had but to start.
This sample of delays in cannabis-based medical trials goes past epilepsy, although.
In September 2018, the NIHR awarded funding for the CANTOP-RCT research, which aimed to judge cannabidiol as a remedy for psychosis. That trial by no means proceeded, with the NIHR citing ‘difficulties in securing a provide of cannabidiol for the research, and developments within the analysis panorama which impacted the unique funding rationale.’
An NIHR name for proposals on medical hashish analysis, open from October 2018 to July 2019, attracted just one utility, which was subsequently declined. The declined proposal had deliberate to analysis cannabidiol for smoking cessation in generalised anxiousness dysfunction.
By the point Ananda’s involvement was introduced in October 2024, the epilepsy trials had been in planning for years.
Co-funded by the Nationwide Institute for Well being and Care Analysis (NIHR) and the NHS, they have been designed to judge the protection and efficacy of Ananda’s cannabinoid medicines in refractory epilepsy throughout as much as 500 sufferers at a number of NHS websites.
On the time, these have been positioned as the most important trials of their type globally and the primary main UK trials into the situation since GW Prescribed drugs’ broadly cited analysis on Epidyolex.
Crucially, these trials have been designed to transcend GW’s authentic work, specializing in a wider vary of epilepsies slightly than simply Dravet Syndrome and Lennox-Gastaut Syndrome.
Chief Government Melissa Sturgess defined in a earlier interview: “As I perceive it, these trials have been first deliberate again in 2019 or 2020—a very long time in the past. They have been initiated as a result of the BPNA (British Paediatric Neurology Affiliation) wished to see extra complete knowledge throughout a broader vary of epilepsies earlier than they felt comfy recommending their specialists prescribe CBD-based medicine for circumstances past Dravet Syndrome and Lennox-Gastaut Syndrome.
“A big period of time was spent discovering a formulation that may meet the regulator’s necessities, which has been a significant problem. We have been invited to tender to provide the drug for these trials and have been lucky to achieve success.
“Within the UK, it is vitally troublesome for specialists to prescribe off-label, particularly for a drug that has been permitted for an orphan indication. The purpose right here is to offer the mandatory knowledge to help CBD as a remedy for a broader vary of epilepsies, which might considerably enhance entry for sufferers.”
First affected person dosing in these trials is not anticipated earlier than 2027, having initially been scheduled to begin this 12 months.
Readouts, equally, are actually unlikely till 2029.
Mixed with what the Firm describes as mental property constraints within the epilepsy indication, administration decided that persevering with involvement represented an unacceptable alternative price.
Sturgess stated in Ananda’s September announcement: “Whereas it’s disappointing that the epilepsy programme has stalled, this final result permits us to focus our assets the place the chance is strongest and the trail to market is clearer.
“We want UCL and GOSH properly of their continued efforts in refractory epilepsies and stay accessible to help them in any means we are able to.”
