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Tuesday, December 15, 2020

Anavex's blarcamesine successful in mid-stage rett syndrome study

 

  • Anavex Life Sciences soars (NASDAQ:AVXL) 50% in premarket on the heels of top-line results from a Phase 2 trial evaluating ANAVEX2-73 (blarcamesine) in adult female patients with Rett syndrome.
  • Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms and correlated with changes in biomarker.
  • 66.7% of ANAVEX2-73 treated subjects showed a statistically significant improvement in drug exposure-dependent Rett Syndrome Behaviour score response as compared to 10% in placebo.
  • 86.7% of patients in ANAVEX 2-73 arm showed a sustained improvement to treatment, as compared to 40% in placebo arm.
  • Primary endpoint was safety. Adverse events were similar between Anavex2-73 and placebo, with no reported serious adverse events.
  • The company is planning to meet with the FDA to discuss steps to approval.
  • https://seekingalpha.com/news/3644357-anavexs-blarcamesine-successful-in-mid-stage-rett-syndrome-study

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