Home Health & Wellness Highlights of Community Q&A Regarding Anavex Life Sciences Ongoing Operations

Highlights of Community Q&A Regarding Anavex Life Sciences Ongoing Operations

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Anavex Life Sciences – the biopharmaceutical company developing innovative clinical therapies for central nervous system disorders like Alzheimer’s, Parkinson’s, and Rett syndrome – was recently the subject of a Q&A conducted by the medical intelligence reporter Spirit of the Coast Analytics.

This Q&A allowed SOTC Analytics to answer a variety of community questions and provide insight into Anavex’s ongoing operations. The following offers some highlights:

Opinions and updates on Blarcamesine

Blarcamesine (also known as Anavex 2-73) is an orally available small-molecule activator of the SIGMAR1 receptor, a protein that stabilises various brain functions. When activated, it has therapeutic applications for neurodegenerative diseases like common central nervous system disorders. Blarcamesine is currently undergoing multiple clinical trials to test its effectiveness in treating Alzheimer’s, Parkinson’s, and Rett syndrome.

Phase 2b/3 trial

Anavex’s blarcamesine Phase 2b/3 The Alzheimer’s trial was a success because it met both of its goals. The primary endpoint was improved cognitive functioning, as shown by higher ADAS-COG scores. The secondary endpoint was improved cognitive and daily functioning, as shown by higher global Sum of Boxes scores.

When asked about the significance of a post-trial statistical analysis, SOTC Analytics explained that it comes down to the importance of statistical data in prescribing patients.

“Because the anchored endpoints were met, further preestablished subanalysis can be explored,” SOTC Analytics reported. “Where subanalysis for responders really shines is in the commercialization stage postapproval. Physicians will be able to prescribe blarcamesine to a vast array of patients based on previously established gene and disease-stage analysis. By breaking out high-confidence responder criteria, physicians can inform patients early on as to their odds of improving (reversing cognitive decline).”

Anavex wants as many people as possible to be able to get blarcamesine because SIGMAR1 activators that can be taken by mouth are better at stopping brain atrophy caused by Alzheimer’s than the monoclonal antibodies that are usually prescribed.

“To my knowledge, Anavex is the only company to halt brain atrophy during a pivotal trial. In fact, monoclonal antibodies exacerbate further brain atrophy and may have even reversed atrophy in some cases,” said SOTC Analytics.

2b/3 publication and FDA approval

The company’s scientific advisory board chair, Marwan Sabbagh, MD, is currently in charge of Anavex’s Phase 2b/3 paper publication. Sabbagh is a behavioural neurologist acting as the leading investigator for many prominent nationwide Alzheimer’s prevention and treatment clinical trials.

SOTC Analytics believes that this publication will play a major role in Anavex cementing pharmaceutical partnerships, and is the reason why the company has waited to file blarcamesine for Food and Drug Administration approval.

“The peer-reviewed 2b/3 Alzheimer’s paper will be extremely important to cementing Anavex’s mechanism and reputation,” according to SOTC Analytics. “It is likely that Dr Sabbagh’s probable prominent role in the paper will be instrumental in this goal considering his reputation and rigour in pursuing promising therapeutics.

“It is likely Anavex will wait to file with the FDA until their 2b/3 [open lab extension study] concludes, and the pending early Alzheimer’s draft guidance is finalised.”

Outlook on other trials

Anavex’s Excellence trial, the third to test whether Blarcamesine therapy could help improve the behavioural problems that come with Rett syndrome, was recently found to have missed its endpoints because there were no behavioural differences between the people who took Blarcamesine and those who were given a placebo.

When asked why they thought the trial missed its endpoints, SOTC Analytics stated that it was likely due to “trial design and strong placebo response,” which is in line with what Anavex has stated about the trial.

“We believe that a high placebo response may have masked the therapeutic effect of this innovative orally available molecule,” Walter E. Kaufmann, Anavex’s chief scientific officer, said. “High placebo responses are well documented, especially in paediatric clinical studies. The early conclusion from the data analysis is that the placebo rate might have been higher in the study. This is because the disease severity at baseline was not the same in both treatment arms, and the drug-to-placebo randomization ratio was 2: 1. We intend to further assess the collective results and discuss with the regulatory authorities next steps.”

While Anavex’s Parkinson’s trials have shown promising results, the company has been slow to initiate additional trials, which SOTC Analytics attributes to Anavex doing its due diligence.

“The pivotal Parkinson’s trial has certainly been initiated in less than spectacular time; however, this is probably due to emerging biomarkers and assays in that field. This is probably related to a desire to be thorough, rather than an inability of management to execute,” according to SOTC Analytics

When treating neurodegenerative diseases as complex as Parkinson’s, it is crucial to account for emerging developments, which Anavex is doing.

As Anavex continues to develop innovative small-molecule therapies for central nervous system disorders, there are bound to be questions regarding the company’s ongoing operations and clinical trials, which is why community Q&A’s like this one are so important

See more recent Anavex news here.

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