Anavex Life Sciences (NASDAQ:AVXL) today revealed that it has gotten the green light from the Spanish Agency for Medicinal Products and Medical Devices to introduce its Phase 2 trial of Anavex 2-73 for the treatment of Parkinson’s disease dementia.
The Phase 2 trial will be a double-blind, placebo-controlled 14-week study that will analyze 120 patients who will take either one of two different doses of Anavex2-73 or a placebo.
The primary goal of the study is to measure cognition and the secondary goals are to measure Parkinsonian motor symptoms and sleep function.
“We are excited about the approval to initiate the Phase 2 study of Anavex 2-73 for the treatment of Parkinson’s disease dementia, which will focus on the effect of Anavex 2-73 on both the cognitive and motor impairment of Parkinson’s disease,” said Christopher Missling, Anavex’s chief executive.
The trial, which kicks off in the coming months, will be held in Europe to start, but may expand to the US and Australia.
Parkinson’s is a neurological disorder, which can trigger dementia in its later stages.
Maxim cites cash on hand
The New York-based biopharma has sufficient cash on hand to fund its clinical trials, according to analyst Jason McCarthy of Maxim Group.
This month, Anavex entered into a so-called "at the market" sales agreement of its common stock for up to US$50mln.
“This, along with its current US$28mln in cash on the balance sheet, should be sufficient runway through the next series of catalysts including the completion of phase 2 studies in Parkinson’s disease with dementia, and Rett syndrome (both to initiate in 2H18) and potentially the P2b/3 in Alzheimer’s disease (AD, initiating 2H18),” wrote McCarthy in a note to investors.
He has a Buy rating and US$7 price target on the shares.
Anavex shares were 2% lower at US$3.37 in afternoon trade.