Anavex Life Sciences Corp (AVXL)

[georgejjl]

Steady_T, The key is the heterogeneity

All right. So we are very excited about the Fragile X program for two reasons. First of all, we have very solid and it is a very strong evident in animal model in Fragile X, which was published last year. And is a new data coming out and among them, it will be presented also at the conference in July, which we pointed out.

And there will be additional biomarker information are making very clear of pathology, biomarker of pathology, they can clear that the drug really improves the phenotype of this disease, which is the largest autism spectrum disorder. And why it's exciting for second reasons, because this largest artisan spectrum disorder is like Rett syndrome under the autism spectrum disorder. And we measured the ADAM score, which is a key measure of anxiety, which is a known feature of limitation and problem for these patients with autism. And we were very successful in the both Rett studies in the Phase 2 and in the Phase 3 AVATAR to successful improvement with the drug on this endpoint of the ADAM score.

And that is why we're very excited, both from the preclinical data, as well as from the clinical data side of point of view. So what we are now doing, we want to make sure that the protocol is very robust because the challenge of Fragile X it's a very diverse patient profile. So they are very different features of the disease, which is not similar. And we want to make sure we are using a population, a trial population, which is as homogeneous as possible so in order to avoid a trial failure because not the drug doesn't work, but because the patients are so different and the endpoints you selected for these patients don't apply to all.

And this is a key what we are now in the process of figuring out then we will meet with the agency and confirm that approach, and also make sure that we can run this as a pivotal study. So we expect this to take place in the second half of this year.

https://www.fool.com/earnings/call-transcripts/2022/05/11/anavex-life-sciences-avxl-q2-2022-earnings-call-tr/

Good luck and GOD bless,