Ananda Pharma on phase I trial progress - ICYMI

Ananda Pharma Plc (AQSE:ANA, OTCQB:ANANF) co-founder and CEO Melissa Sturgess talked with Proactive about the company’s progress towards beginning its first clinical trial in Australia for its cannabinoid-based drug candidate.

Sturgess confirmed that the drug development stage is now complete, allowing the company to move into trials involving healthy volunteers. The trial will compare the pharmacokinetic profile of Ananda’s candidate with Epidiolex, the only CBD drug currently approved by regulators.

“We’ve just finished all the drug development work… [and will] compare [our drug’s] pharmacokinetic profile… with Epidiolex,” said Sturgess.

She discussed the recent appointments of Giles Moss and Chris Tovey—both former senior executives at GW Pharmaceuticals, the company behind Epidiolex—as strategic moves to strengthen Ananda’s commercial and regulatory capabilities as it enters the clinical phase.

The Australian Therapeutic Goods Administration has acknowledged Ananda’s first trial. Sturgess noted that Australia offers both strong tax incentives and compatibility with US FDA requirements, helping the company advance its program cost-effectively while also preparing for potential regulatory pathways in the United States.

Each step forward, Sturgess said, brings Ananda closer to dosing its first volunteers in what she described as a critical phase of development.

Proactive: Melissa, very good to speak with you. You've brought Giles Moss on as an advisor as you move closer to your phase one trial in Australia. Can you tell us more about Giles and the significance of his appointment?

Melissa Sturgess: So, Giles is an ex-senior executive from GW Pharmaceuticals. We announced a couple of weeks before Giles joined as an advisor, also Chris Tovey joined us. Both of them were senior at GW and were involved very much in later-stage drug development, more from a commercial and corporate perspective.

So we're investing in how to build our team and how to get through the regulatory pathway. Now that we're moving from the early stage of drug development into the clinic, starting to put our drug into patients, we're working on the basis that our clinical trials will be successful and we'll get positive results.

Having a team that was involved in the only regulatory-approved CBD drug, Epidiolex, makes sense. We want people who can help us navigate this journey faster and cheaper than the previous regulatory-approved drug.

Proactive: And the clinical trial in Australia is commencing shortly?

Melissa Sturgess: Yes. We've just finished all the drug development work, and that allows us to put our drug into healthy volunteers and compare its pharmacokinetic profile—how it functions in the blood plasma—with Epidiolex, which is already on the market.

Proactive: And Australia's Therapeutic Goods Administration has acknowledged your first clinical trials. So another step towards that trial then, Melissa?

Melissa Sturgess: Yeah, it absolutely is. These may seem like baby steps, but they’re giant steps for Ananda. Every box we tick takes a long time, but once ticked, it means we can move to the next step. As you say, it's moving us to the point where we put our drug formulation into healthy volunteers for blood testing.

Proactive: Melissa, why Australia for that first trial?

Melissa Sturgess: Good question. Two main reasons: first, from a corporate perspective, Australia has a very good tax rebate system. It’s very tax-effective to do R&D there. Second, all the work done in this trial will meet the requirements needed for a US regulatory pathway. So we get both good tax breaks and a leapfrog down the US FDA pathway.

Proactive: Melissa, I hope you'll continue to keep us updated with progress. Thank you very much for speaking with us today.