Hi Paul,there has been an announcement by BOD that their phase...

Hi Paul,

there has been an announcement by BOD that their phase 2B trial for insomnia has had some successful results. They are moving towards a schedule 3 with the TGA. How does this place us? It would seem to be great validation but are we closer to being TGA approved given we are soon to start Phase 3 trials?

thank you

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Avecho Biotechnology Limited

ASX:AVE

08:52AM 08/09/2023

Hi Phil,

We read the BOD results with great interest and I did have a number of interested shareholders reach out to ask what we could learn heading into our own study. Although their study failed their primary endpoints, it was validating to see a signal for improved sleep using CBD when compared to placebo, even if only in a post-hoc statistical analysis.

The two items that leapt out to us were the following; dose and powering.

BOD tested 50mg and 100mg versus placebo. Their analysis suggested that 50mg didn't work, whereas there was a signal that 100mg did, ie. you need higher doses of CBD to get improved sleep. We are using 75mg and 150mg on our trial, so we're already using a higher dose. Plus, we have our increased absorption to further increase the amount of drug absorbed. So, we're feeling pretty good that BOD's results show that we've got the dose/product correct.

On the powering side, BOD failed to get statistical significance for their primary endpoint (@ p<0.025). But, using a post-hoc analysis, they saw a subset of patients with statistically signifance changes (p<0.05). The way you increase your chances of statistical significance (assuming no change in effectiveness) is simply by dosing more patients. BOD dosed 208 patients. We are planning on dosing about 540. The increase in statistical power in our study is very large, maximising our chance of success in the primary endpoints (required for TGA approval).

In summary, BODs results appear to show that CBD works for sleep, de-risking our trial (thank you BOD!). They showed that the study ideally needs higher doses of CBD and more patients on study, which is exactly what we had planned.

Cheers,

Paul