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Anavex Life Sciences Reports the Results of Review by the Independent Data Safety Monitoring Board for its Phase 2/3 Trials of ANAVEX2-73 in Patients with Rett Syndrome - Seite 2

Nachrichtenquelle: globenewswire
12.04.2021, 13:00  |  186   |   |   

The respective ongoing placebo-controlled Phase 2 and Phase 2/3 ANAVEX2-73 clinical studies in adult (AVATAR) and pediatric (EXCELLENCE) patients with Rett syndrome are expected to be completed by mid 2021 and 2H 2021, respectively.

ANAVEX2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.4

PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX2-73.5

Anavex Life Sciences’ product portfolio includes small drug molecule lead candidate ANAVEX2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.

About ANAVEX2-73-RS-002 AVATAR Clinical Study (NCT03941444)

The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX2-73 to treat Rett syndrome in a total of 33 adult patients with Rett syndrome over a 7-weeks treatment period incorporating precision medicine biomarkers. Preceding the placebo-controlled randomization of 30 patients (Part B), a 3-patient cohort (Part A) underwent a pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX2-73. All patients who completed the study are eligible to continue to receive ANAVEX2-73 for additional 48 weeks within the open label extension protocol.

About ANAVEX2-73-RS-003 EXCELLENCE Clinical Study (NCT04304482)

The Phase 2/3 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX2-73 to treat Rett syndrome in at least 69 pediatric patients with Rett syndrome over a 12-weeks treatment period incorporating precision medicine biomarkers. All patients who completed the study are eligible to continue to receive ANAVEX2-73 for additional 48 weeks within the open label extension protocol.

About ANAVEX2-73-RS-001 U.S. Clinical Study (NCT03758924)

The Phase 2 trial is a randomized double-blind, placebo-controlled safety, tolerability, pharmacokinetic and efficacy study of oral liquid ANAVEX2-73 to treat Rett syndrome in a total of 31 adult patients with Rett syndrome over a 7-weeks treatment period were evaluated incorporating precision medicine biomarkers. Preceding the placebo-controlled randomization of 25 patients (Part B), a 6-patient cohort (Part A) underwent a 7-weeks pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX2-73. All patients who completed in the study were eligible to continue to receive ANAVEX2-73 under a 36-week open label extension protocol (ANAVEX2-73-RS-EP-001).

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Anavex Life Sciences Reports the Results of Review by the Independent Data Safety Monitoring Board for its Phase 2/3 Trials of ANAVEX2-73 in Patients with Rett Syndrome - Seite 2 NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) - Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and …

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