November 24, 2014
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
AVANIR Pharmaceuticals did a solid job of presenting data on its experimental Alzheimer’s drug, AVP-925, at this year’s conference on Clinical Trials on Alzheimer’s Disease and the company should see some upside as a result, said Ritu Baral, a biotech analyst with Cowen & Co., on Monday.
“Based on our conversations with Alzheimer’s (ALZ) key opinion leaders (KOLS) at the conference, Avanir is rapidly establishing relationships with the ALZ KOLS community, which should assist with a timely start and conduct of a Phase III AVP-786 Alzheimer’s agitation program,” said Baral in a note to investors.
Baral said that there were a number of clinical presentations that review the potential etiology of Alzheimer’s agitation, in brain morphology and functional imaging as well as changes in inflammatory biomarkers and neurotransmitters.
“Of note, areas of atrophy seen in dementia patients with agitation (eg amygdala, cingulate) overlap with the neuronal tracts impacted by AVP-925,” she said. “Further, presenters speculated dysregulation of norepinephrine and serotonin levels and signaling (also impacted by AVP-925 along with its NMDA and sigma-1 activity) are also involved in Alzheimer’s agitation.”
Baral added that another interesting data presentation was of the additional analyses of the CitAD study of citalopram in Alzheimer’s agitation.
“[Notably] a study of the QT elongation seen in CitAD shows a worrisome 18ms mean QT elongation at the 30mg qd dose studied in the trial. A 20ms elongation is widely acknowledged to be proarrythmic,” she wrote.“The study authors concluded the data supported use of the lower 20mg dose in elderly patients. We think this safety data weakens the potential of generic citalopram as serious competition to AVP-925/786 in Alzheimer’s agitation.”
