Euroz Hartleys | Successful Phase 3 Interim Results
Euroz Hartleys has released a new research report, upgrading its price target on Avecho to $0.060 per share following successful Phase 3 interim results in Avecho’s insomnia program.
Key highlights from the report include:
- A major de-risking event, with the independent Data Monitoring Board unanimously recommending the trial continue to its originally planned 519 patients — with no increase to patient numbers required
- A clean safety profile, with no serious adverse events identified across the 244 patients dosed at either the 75mg or 150mg dose
- Continued commercial validation through the existing Sandoz licensing agreement, struck at risk ahead of these results, with up to A$23m in development milestones plus tiered royalties of 14–19% on net sales
- A significant, still-untapped market opportunity, with an estimated 9.5 million Australians experiencing insomnia and a total addressable market of ~A$900m per annum in Australia alone
- Accelerating global licensing discussions, with major regions including the US and Europe still to be licensed, and the interim result seen as a catalyst for further deals
Author Seth Lizee commented:
“This represents a major catalyst that materially de-risks the Phase 3 trial and takes AVE a step closer to bringing its insomnia treatment to market. If approved, the drug would also become the first and only over-the-counter (OTC) CBD treatment in Australia, available without a prescription and, with no competitors in late-stage development, positioned to command an effective monopoly.”