Looking Under The Hood of PDD Phase 2 Blarcamsine Results. $AVXL $ANVS

Do not trade this blog as 4 billion years of evolution is against me and possibly even God laughs at it, He has a great sense of humor!

One Picture Worth Few Drugs….

Section of AD/PD Conference 2022 Poster presented by Anavex Life Sciences. The full poster can be downloaded at https://79bcf7a1-8b8e-483b-b7cf-f5c5192a6d63.usrfiles.com/ugd/79bcf7_ff6b864593fb4418ab306474dd535d35.pdf

Before I delve into the pretty picture here I shall reference the UPDRS content as it is undoubtfully of great value in understanding the implications of this section of the poster.

Link to UPDRS shortened form. https://www.psychdb.com/_media/geri/updrs.pdf

The improvents vs. the placebo in the mean for the patients are for the high dose cohort in each of the parts of UPDRS questionnaire. The error bars might be the Standard Deviation of the data. The number of patients in this exploratory Phase 2 trials is quite large as we have 44 patients at the start and 38 at the end of trial. This is as close as it gets to a minimal but valid sample of the population. What statisticians say is that statictic does not prove anything but sure it does prevent you from reaching wrong conclusions.

The parts I and II exhibit great changes in both placebo and dosed cohorts, which suggests that what I would called “reversed placebo effect”, Possibly, due to disappointment over the lack of expected therapetic effect in placebo cohort. The deterioration in more or less defined daily living scores is quite greater than in those involving motor skills in the just 14 weeks duration of the trial. I would squarly placed the blame on hypothetical “reversed placebo effect”.

Another issue is that the mean changes in the scores are though not large, for example -4 points for Part III they translate into large qualitative changes for particular patients. In part III some patients has achieved the change of 7.5 points and they seem still be within Standard Deviation. Even a cursory view of the UPDRS reveals that these are significant changes in motor condition of some patients. The general condition of the patients centers around the divide between mild/moderate (the divide being 32/33 points).

Source as Listed in Previous Publication for the Poster

With the score of 38.3+/-15.2 for Part III the trial mostly samples the mild to moderate patients with about from 6 to 10 years of disease diagnosis. The preventative/restorative character of Blarcamesine treats the best patients with mild disease over those more advanced. As far as we know right now there is also a bias toward those with the greater production of the SIGMAR1 protein. Some of the data in this part of my post I have taken from the reference: link https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.12476

Parkinsons’s patients taking current Parkinso’s drugs experience period of ON therapetic effect and OFF therapetic effect. The above reference list the Part III scores for these two conditions experienced by the patients. The aggregate difference is just 0.4 points. Comparing this to solid 4 points on Blarcamesine we are talking about multiplier of 10.

Due Comparison With Posiphen ($ANVS)

From AAIC Panel July 28, 2021 presentation …

The Part III results are under Posiphen improving anout 2% and Part IV in quite stunning reversal still deteriorates. If we assume that the means score for patients in this trial was just the same as for Blarcamesine for Part III that the mean improvent is just 0.7 points making the Blarcamesine score almost 6 times larger.

Conclusions

  • The improvents in all four parts of the UPDRS are consistent across all measures and are well separated from placebo
  • Parts I and II are much more easly affected than parts III and IV, yet the most significant therapetic effect can be found in the latter measures for Blarcamesine. A very or the only effective drug.
  • This status of Blarcamesine is corroborated by the results from $ANVS ‘s Posiphen with lack of significant response in parts III and IV.
  • Parts III and IV show very stable characteristic for the patients over time. Nevertheless, Blarcamesine (mean of improvenet of the sample) can improve them over 10 times better than current drugs. All in short duration of 14 weeks.
  • Parkinson’s is etiologically connected to atrophy of motor neurons in the brain and perifery. By restoring or ameliorating the motor skills of patients, Blarcamesine seem to address the disease as understood by now, not just the symptoms.
  • The implications from all the parts suggests disease altering therapeutice effects for the patients. The unanswered question is “Would Blarcamesine administered earlier stop the progression of the disease or even reversed it, at least for some?”

Sorry for all the spelling and grammar mistakes.

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