Anavex Life Sciences Corp (AVXL)

[sokol]

Good post. Yes, we have seen announcements that confirm that Blarcamesine does show improvement “day by day” and that stopping administration of Blarcamesine patients worsen only to begin improving again when treatment with Blarcamesine resumes.

We do have information that Missling says proves that continual dosing of Blarcamesine is important to response and that by halting intervention, patients worsen but can reverse for the better again by resuming treatment with Blarcamesine.  So, it will be interesting to see if Anavex continues collecting data on patients in OLE and/or for compassionate use. It seems that Anavex is doing that. Some patients have been taking Blarcamesine for over two years. See below.

1.  This is from Mayo's SOTC website.  SOTC Update 5: 26 June 2023

Presentation at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference
- 11:15 min: Alzheimer's vs. Parkinson's

    -         - S1R does not discriminate based on pathology (initial cause of the disease). In Parkinson's genes, we found active arm (dosed patient) genes were up-regulated again. Functionality was improved on a molecular level. In the OLE, we proved that continual dosing is important to response and that by halting intervention, patients worsen but can reverse for the better again by resuming treatment -- beyond simple endpoint measures, this was also true at the gene level [new information]. We are now about to conduct the imaging (target engagement) study and Parkinson's disease pivotal trial which are both still being funded by MJFF.

2.  Further, see ANAVEX®2-73 (Blarcamesine) Shows Clinical Benefit in Long-Term 48Week Phase 2 Extension Study in PDD - https://www.anavex.com/post/anavex-2-73-blarcamesine-shows-clinical-benefit-in-long-term-48week-phase-2-extension-study-in-pdd

Due to the COVID-19 pandemic, the start of the extension phase was delayed, on average, by approximately 41 weeks at the end of the preceding double-blind placebo-controlled study (DB). This led to a reduced enrollment rate for the extension phase. The period between the end of the double-blind phase to the start of the extension phase, where patients were not on ANAVEX®2-73 treatment, is known as a 'drug holiday'. The drug holiday period of treatment separation provided an opportunity to compare the trajectory of clinical scores between no ANAVEX®2-73 treatment (drug holiday) and ANAVEX®2-73 treatment in the extension phase.

All efficacy endpoints, which includes the MDS-UPDRS Part II + III and Clinical Global Impression -- Improvement (CGI-I) measured at the end of trial of the double-blind study (DB EOT), the OLE Baseline, OLE Week 24, and OLE Week 48, showed a worsening during the drug holiday. However, a consistent improvement was observed during the extension phase when patients resumed ANAVEX®2-73 treatment. These results are consistent with the pattern observed for all efficacy measures in the extension phase (see Chart and Table).[[6]](https://manage.wix.com/dashboard/e1cd7807-443e-425e-9433-41548681800c/blog/cb39a577-fa42-405a-a247-31bbefc78067/edit#_ftn3)

.....
"It is encouraging that the patients' clinical symptoms consistently improved longitudinally over time during the extension phase under active ANAVEX®2-73 treatment," said Christopher U Missling, PhD, President & CEO of Anavex. "This data suggests ANAVEX®2-73's potential capability to slow and potentially reverse the life altering symptoms of Parkinson's disease, an urgent unmet global need."

  
Moreover, at the request of the participants completing the 48-week open-label extension study, patient requested treatment with ANAVEX®2-73 is continuing beyond the open-label 48-weeks through the compassionate use Special Access Scheme. Currently, participants in the compassionate use program for ANAVEX®2-73 have been on average, for over 2 years and counting.