ATH-1017 Phase 2 Completes Enrollment, Heart Rate Variability as SUDEP Biomarker, Migraine Not Associated With Insomnia

Neurology News Network for the week ending November 27, 2021.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

The phase 2 ACT-AD clinical trial evaluating Athira Pharma’s investigational agent ATH-1017 in patients with mild-to-moderate Alzheimer disease (AD), has completed enrollment, with results expected to be announced in the first half of 2022, according to the company.This ongoing randomized, double-blind, placebo-controlled, 26-week trial will assess ATH-1017, a positive modulator of hepatocyte growth factor (HGF)/MET, in the treatment of 77 patients across 14 sites in the United States and Australia. Patients were randomized 1:1:1 to 1 of 2 dose groups of daily subcutaneous ATH-1017 or placebo and will continue to be evaluated for improvements in cognition, global, and functional assessments. Event-Related-Potential (ERP P300), a functional measure of working memory processing speed, will be measured through EEG. EEG will also be used to measure quantitative EEG (qEEG). Patients who complete the 26-week treatment period during ACT-AD or LIFT-AD, Athira’s other ongoing clinical trial of ATH-1017, may enter an open-label extension period in which they receive the study drug at a high dose of 70 mg/day for an additional 26 weeks.

Newly published data from a retrospective study spanning more than 10 years found an association between heart rate variability (HRV) and sudden unexpected death in epilepsy (SUDEP). The findings, which also showed that increased high-frequency power (HFP) is associated with longer survival, carry significant clinical meaning as clinicians have tried for years to identify biomarkers of SUDEP.In the largest SUDEP biomarker study to date, senior author Orrin Devinsky, MD, director, Comprehensive Epilepsy Center, NYU Langone, and professor of neurology, NYU Grossman School of Medicine, and colleagues compared HRV in 31 SUDEP cases and 56 controls who had video-EEG monitoring data. Patients had time-domain and frequency-domain components extracted from 5-minute interictal electrocardiogram recordings during sleep and wakefulness from SUDEP cases and controls. In wakefulness, normalized LFP in SUDEP cases was significantly lower than in epilepsy controls. This difference was preserved after adjusting for relevant covariates

Data from a recent study suggest that migraine and tension-type headache diagnoses were not associated with the presence of insomnia. However, substantial and very severe impact of headaches, as well as presence of anxiety, were associated with insomnia. Conversely, frequency of headache attacks and impact of headaches were also associated with severity of insomnia. A total of 420 university students agreed to participate and were enrolled in the study, with a median age of 21 (standard deviation 19-23). Insomnia was found in 95 (22.6%) participants, 265 (63.1%) had migraine, 152 (36.2%) had tension-type headache, 182 (43.3%) had migraine with aura, 201 (47.9%) had anxiety, and 108 (35.7%) had depression. Data show that presence of insomnia was associated with substantial or very severe impact of headache and anxiety, with investigators predicting university students who suffer from depression, anxiety, and severe headache have a 58.1% probability of also having insomnia. Comparably, for those that do not have depression, anxiety, or have substantial/very severe impact of headache, investigators predicted chances of developing insomnia at just 5.5%.

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