logo-loader
Anavex Life Sciences

Anavex to advance Alzheimer’s drug with larger Phase 2/3 trial

It comes as the US FDA provided Anavex with guidance on its proposed strategy for the drug candidate.

pills.jpg
Anavex believes its approach will be more efficient

Anavex Life Sciences (NASDAQ:AVXL, OTCMKTS:AVXL) has told investors it will advance regulatory filings for the development of its Alzheimer’s drug.

It comes as the US Foods and Drugs Administration (FDA) provided the company with guidance on its proposed strategy for the drug candidate.

The company said it will advance a larger and more innovative Phase 2/3 trial for the drug, ANAVEX 2-73.

Christopher Missling, Anavex chief executive, said: “By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73.”

Missling highlights that the prior Phase 2a trial used Adaptive Design and Population Pharmacokinetics/Pharmacodynamics (PK/PD) modelling, which he says was a “major strength” which benefits the drugs development for Alzheimer’s disease as well as other central nervous system (CNS) diseases.

The proposed Phase 2/3 trial will be double-blinded, randomized and placebo-controlled.

In pre-market trading the Nasdaq quoted shares were up 87 cents, about 27%, changing hands at US$4.11. It comes after a sharp drop in the price, down to a US$3.24 close, on Tuesday.

Quick facts: Anavex Life Sciences

Price: $2.71

Market: NASDAQ
Market Cap: $142.68 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Full interview: Arcadia Biosciences makes major progress on its hemp venture...

Arcadia Biosciences Inc (NASDAQ:RKDA) CEO Raj Ketkar tells Proactive the California-based company expects to “significantly scale revenues in 2020” as it reported financial and business results for the second quarter and first half of 2019. Ketkar says the agricultural innovation company made...

1 day, 9 hours ago

2 min read