Anavex Life Sciences Corp (AVXL)

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The Anavex 3-71 Schizophrenia Study — Short and Strong

The Anavex 3-71 trial for the treatment of schizophrenia has officially begun. The first patient has entered the trial.

https://www.globenewswire.com/news-release/2024/03/18/2847701/29248/en/Anavex-Life-Sciences-Initiates-Placebo-Controlled-U-S-Phase-2-Clinical-Trial-of-ANAVEX-3-71-in-Schizophrenia.html

This trial will differ in several ways from any of Anavex’s previous human trials, in three significant ways.

First, this is the first Phase 2 trial of Anavex 3-71 in humans. To date, Anavex’s lead drug being tested and targeted at central nervous system (CNS) diseases has been Anavex 2-73, blarcamesine. Now, for the first time, it will be Anavex 3-71

In murine (lab animal) studies, Anavex 3-71 has been shown to be clinically functional at very small dosages, measured in micrograms, compared to the milligrams required for blarcamesine. (A microgram is one one-thousandth of a milligram; 1 microgram = 0.001 milligram.) With this, in both murine and Phase 2 safety and tolerability studies in humans, the drug has proven to be very safe, with no treatment-obviating adverse events (“side effects”). This contrasts with the very common and significant side effects of existing drugs used to treat schizophrenia.

Simply, the drug works safely and strongly.

Secondly, the two drug testing periods for the new trial, where Anavex 3-71 is being tested on patients with schizophrenia, are very short. In Part A, a proper statistically-valid double-blind, placebo-controlled, multiple ascending dose trial, will be used to select the exact dosage to be used in the main study, in Part B. The Part A study will take just 10 days for each enrolled patient.

The Part B study period, using the Part A-determined dosage, to see if Anavex 3-71 can yield safe, effective therapeutic outcomes for patients with schizophrenia, will require only 28 days of dosing and patient study.

Lastly, it appears that the biochemical anomalies that cause the symptoms of schizophrenia lend themselves to prompt, almost immediate amelioration by Anavex 3-71. Hence, the short study period of the trial.

And, as stated in the announcement, to determine treatment efficacy, “Standard clinical outcome measures, including the Positive and Negative Syndrome Scale (PANSS), and novel fluid and electrophysiological biomarkers will be assessed.”

At the end of the study, sometime soon, there should be no haziness or statistical questions about Anavex 3-71's ability to successfully treat schizophrenia. Millions of patients suffering from schizophrenia can have hope.