February 18, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The chief executive of drug candidate development company Anavex Life Sciences told BioSpace Wednesday that its experimental drugs for Alzheimer’s disease will see major developments in 2015, after its Anavex Plus combo showed up to an 80 percent greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
Christopher U. Missling, the president and CEO of Anavex, told BioSpace that the company’s “most exciting development in 2015” is to have started a Phase IIa clinical trial in Alzheimer’s disease with lead drug candidates, Anavex 2-73 and Anavex Plus, the combination of Anavex 2-73 and donepezil (Aricept).
“This is an adaptive trial for which we expect to report initial data in the third quarter of 2015. Anavex 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase I with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease.
Missling said that 80 percent greater reversal of memory loss in Alzheimer’s disease models is an enormous incentive to keep testing, and should make for an interesting year for the company. “With recent third party data validating our target, our strong pre-clinical data, as well as positive Phase I profile, Anavex has good reason to be excited for our current Phase IIa,” he said.
The market for Alzheimer’s therapies has shifted over the last few years, Missling told BioSpace, after so many drugs have faltered at the final clinical trial finish line.
“The need for better treatment options for Alzheimer’s disease has further increased after recent failures of several drug candidates in Phase III, among them, bapineuzumab (Pfizer Inc. , solanezumab (Eli Lilly and Company , crenezumab (Roche and gantenerumab (Roche),” said Missling. “The last drug approved for Alzheimer’s was over 10 years ago.”
Because of that legacy of failure, Missling said Anavex went to particular pains to design its recent trials with past mistakes made by its competitors in mind, hoping to vet its drugs as thoroughly as possible scientifically before ginning up too much investor enthusiasm.
“Speaking of the ongoing trial, the company wanted to avoid the same failure that the other Alzheimer’s drug trials experienced,” Missling told BioSpace. “Therefore, we designed our trial to be a more efficient study than a conventional study with the implementation of an adaptive trial design. We are proud to utilize the latest FDA guidelines in our trial in order to gather as much information as we can from each patient. The data we will gather from this trial will lay a great foundation to lead to a more successful Phase III trial.”
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