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Replies to post #427875 on Anavex Life Sciences Corp (AVXL)
08/21/23 5:21 AM
Charles Duncan -- Cantor Fitzgerald -- Analyst
OK. Super. Thanks, Clint. Hi, Christopher and team.
Thanks for hosting the call. Had a couple of questions on the recent AVATAR readout. One on EXCELLENCE and then I wanted to ask Sandra a little bit about the cash runway. So regarding AVATAR , we were quite intrigued with recent results, but I guess I'm wondering if you had assessed just simply the change from baseline in RSBQ and CGI and if you intend to present that data here in the near term.
And then, regarding the expanded access, is that part of an open label extension study? Or open label extension to the AVATAR study?
Christopher Missling -- President and Chief Executive Officer
Right. So get me first on the last question. The idea is expanded access is to provide not only for those patients which have been participating in the trials to give the drug for free so they can continue to enjoy the treatment effect, but also those patients, which are not part of the trial. So that is the definition of the expanded access.
So that's what we were considering and working toward. Regarding the first question, let me explain again the background of the respond analysis, and the results of the animal studies for Rett syndrome and other neurodegenerative diseases indicated that ANAVEX 2-73 has both symptomatic and disease modifying effects on neurodevelopmental and degenerative diseases. And for that reason, the ANAVEX 2-73 analysis of the data should capture this kind of effect. And this is done in the form of the way we have presented it as a respond analysis with the RSBQ you see.
[Inv2014 comment: Above in red did not appear to have happened, but instead "ANAVEX®2-73 Receives Compassionate Use Authorization for Pediatric Patients with Rett Syndrome" from Canada. Also in same PR "Approved compassionate programs are also ongoing in the United Kingdom and Australia, representing all regions of the Rett Syndrome study participation."] and
[Missling further says, which of course is good and expected, but will not cover "those patients, which are not part of the trial."] “While our clinical studies with ANAVEX®2-73 (blarcamesine) are very critical to collect clinical information for regulatory purposes, we also recognize the long-term commitment to our investigators, patients and families. Therefore, post clinical studies, we are keen to provide supply to the investigators that have requested compassionate use of ANAVEX®2-73 (blarcamesine) for their patients on a global basis. In compliance with local authorities, many patients from our clinical studies are now able to continue treatment with ANAVEX®2-73 (blarcamesine).”
Now on top of that, we have seen and we've learned in the paper, which was accorded and explicitly mentioned also in the presentation of February 1st, pointed out that the RSBQ alone is a stand-alone, has just so many flaws that has, for example, 200 percentage upswing and in downswings and is not calibrated in the baseline, so it's just not fair to use it. Whatever, however, what we can say is that, we make a reference of what is the CGI requirement of a one point scale improvement, which is a three or less, which is a minimum improvement of clinical significance and that represents a RSBQ change of average of 12.5 reduction of the RSBQ scale. So, knowing now that you have above average over 72% responder, which are better than score of three, so they can have also a score of two, which we have seen in this study. So you can see that RSBQ average needs to be at least more than 12.5 delta.
So I hope that helps to explain this a little bit better.
[Inv2014 comment]: Well Missling did not explain why the readout slide deck mentions AUC and CGI-I Anchoring when this is not part of the SEC filings and also did not address how on earth the two separate endpoint outcome measures are exactly identical.]
Charles Duncan -- Cantor Fitzgerald -- Analyst
It does, Christopher. I appreciate that. Definitely appreciate linking RSBQ to clinical benefit. Let me turn to excellence.
I guess I'm wondering if you'll use this same evaluation as was used in AVATAR because I think clin trials has had a little bit different, and you might correct that. And then the second thing about EXCELLENCE, is that in terms of the patient enrollment to date, can you give us some color on the number of patients enrolled and when during the second half of '22 you would anticipate that study readout?
Christopher Missling -- President and Chief Executive Officer
Yeah. So the enrollment is going well. It's just that we learned that because of the COVID vaccines have been approved around the world, and also have been approved for children, which are younger than 18, and the requirement is now that all these participants want to and need to and it's a fair proposition to get vaccinated. The protocol, however, requires that you have to be on a constant medication several weeks.
I think it's six or eight weeks in advance before joining a trial, so that means that you have to get the first dose of the vaccine, but also the second one. And in time, and then you have to allow for some time to pass by to be on a stable, new indication on a new medication and the vaccine is a new medication. So what it does, it shifts a little bit about the timeline to finish the last patients in this trial. What was the other question, Charles? I just --
Charles Duncan -- Cantor Fitzgerald -- Analyst
Yeah. Was just wondering if you can provide some color on the number of patients enrolled thus far?
Christopher Missling -- President and Chief Executive Officer
We are doing well from our perspective. I like to just mention that right now, we're very comfortable with the timeframe to being second half '22. That gives us ample time to complete the study with this additional required vaccination regimen. So, this is sufficient for us at this point to share.
Charles Duncan -- Cantor Fitzgerald -- Analyst
OK. And you may narrow the time frame from, say, second half to a little bit more granularity in the future as your enrollment progression?
Christopher Missling -- President and Chief Executive Officer
Exactly right. Yes.
Charles Duncan -- Cantor Fitzgerald -- Analyst
OK.
Christopher Missling -- President and Chief Executive Officer
And, in regards to the ClinicalTrials.gov, I would like to make again a statement here that the ClinicalTrials.gov is not what we want to refer as to company communication. It will be updated eventually. So I like to you to be aware of that. So the company communication is has priority over ClinicalTrials.gov, but it will be updated when we have finalized the study outcome, and then we will also update the ClinicalTrials.gov.
Right now, it's might not be completely up-to-date, so I want to make sure people understand that.
