Ananda Pharma
UK-based cannabinoid pharmaceutical company Ananda Pharma has received ethics approval for a Phase 1 clinical study for its lead compound in Australia.
In an update to investors this week, Ananda announced that the Alfred Hospital Human Research Ethics Comittee (HREC) has approved its application to launch a Phase 1 pharmacokinetic study into its flagship CBD drug candidate, MRX1.
Business of Cannabis reported in October 2024, that Ananda had signed a contract with a leading Australian contract research company to conduct further clinical trials on its flagship CBD compound, MRX1.
This trial, according to Ananda, is particularly important as it will collect essential data regarding how the compound is absorbed, distributed, metabolised and secreted by humans, alongside the safety and tolerance levels following both single and multiple doses.
Furthermore, it will serve as a core element for future clinical trials and regulatory filings, with key applications expected for both the UK’s Medicines Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).
MRX1 will be given to 20 healthy volunteers who will be monitored closely for six days, and the company eventually aims to target complex chronic inflammatory pain conditions.
Now that HREC has confirmed the Phase 1 trial protocol meets the necessary ethical standards, recruitment for the study can commence.
Ananda now expects the first patient doses to be administered in Q3 of this year, and the initial results to be published in early 2026.
The company notes that while this trial is not necessary for the start of its dual Phase 2 endometriosis and chemotherapy-induced peripheral neuropathy trials in the UK, the findings will help inform future regulatory filings in key markets.
In late February, Ananda said the manufacture of its final ‘technical batch’ of MRX1 had been completed, meaning the next manufacturing batch will be delivered to the UK clinical trial sites and dosed to participants.
The next step is to produce the first Good Manufacturing Practice (GMP) clinical batch of MRX1 for dosing.
Ananda is not the only company utilising Australia’s favourable tax incentives for R&D initiatives, which include a 43% rebate on eligible research costs.
Kingdom Therapeutics, a UK-Irish biotech company, also chose to launch clinical trials into cannabis and Autism Spectrum Disorder (ASD) in the country, which is fast becoming a research hub for pharmaceutical cannabis and biotech companies.
Stenocare
Danish medical cannabis manufacturer Stenocare has announced the launch of its fourth oil product in its home market, days after publishing its annual report for 2024.
For the full year 2024, Stenocare posted a net EBITDA loss of DKK 24.2m however, as Business of Cannabis has previously reported, this includes a one time loss of DKK 13.05m related to exit of cultivation facility, as the company transitions away from a vertically integrated model.
Without the sale of its facility, its EBITDA loss was DKK 11.2m, down slightly from a loss of DKK 12.6m in 2023. This, in turn, reflected its total assets which fell from DKK 38.1m in 2023 to DKK 19.4m.
Gross sales came in at DKK 4.8m, which was aboved its significantly downgraded guidance of DKK 4.5m.
However this still fell short of 2023’s DKK 6.9m and of its initial expectations of DKK 15m.
The lower than expected sales in the Danish market due to internal regulatory issues drove Stenocare to pivot its strategy during the year, and ultimately to sell its cultivation operations and opt for third party supply integration.
“This new strategy builds on the assets that have successfully positioned Stenocare with approved products available in six countries,” it said in its annual report.
“With this strong foundation, we have developed a proven logistical and distribution network that enables us to reach pharmacies and patients effectively.”
With its new strategy expected to save DKK 4-5m annually, Stenocare expects to reach break-even EBITDA during 2025, and see net profit by 2026.
The company also completed a capital raise in January 2025 of DKK 7.9m, which it says will give it enough runway to operate until 2026 without additional funding.
Synbiotic
German hemp and cannabis buy-and-build group Synbiotic has announced the launch of Germany’s first THC-containing medical cannabis pastilles
Developed over three years in collaboration with Bolder Arzneimittel GmbH & Co and partner pharmacies, the new formulation is expected to be launched into the market this year.
Its new pastilles, according to the company, will offer precise, reproducible dosing, faster onset and discreet administration over other consumption options.
“Our goal was to develop a dosage form with the most advantages—and now we’ve succeeded,” said Synbiotic’s Managing Director Daniel Kruse. “This personalized medicine will set new standards for cannabis-based therapies.”
Unlike traditional cannabis products, the pastilles are tailored to each patient’s prescription and produced in pharmacies using pharmaceutical-grade ingredients.
Distribution to pharmacies will be handled by Synbiotic subsidiaries Weeco Pharma GmbH and MH medical hemp GmbH, with prescriptions issued on a patient-specific basis by treating physicians.
