Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced that it is enrolling patients into an open label extension (OLEX) study for its ongoing Phase 2/3 LIFT-AD and Phase 2 ACT-AD studies of ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease.
“This treatment extension allows us to meet investigator and patient interest in continuing treatment with ATH-1017. We can now collect up to 1 year of safety and efficacy data on ATH-1017, and patients who received placebo during the randomized portion of the trial will now be able to receive up to 26 weeks of therapy,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira. “It’s rewarding to have our first patients completing six months of study now continue their treatment. Our novel treatment approach is agnostic to the underlying disease pathology and is designed to focus on neuronal regeneration, which has the potential to improve clinical outcomes for patients.”
“There remains an urgent need for therapies that improve cognition for patients who are living with mild-to-moderate Alzheimer’s disease,” said Michael Mega, M.D., Ph.D., Director of the Center for Cognitive Health and a principal investigator in the ACT-AD trial. “The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.”
The LIFT-AD and ACT-AD trials are evaluating ATH-1017, a small molecule therapeutic designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are expressed in the central nervous system, in order to promote brain health and function. The randomized, double-blind, placebo-controlled trials are evaluating the safety and efficacy of ATH-1017 in mild-to-moderate Alzheimer’s disease. Patients are stratified 1:1:1 to receive low dose ATH-1017 (40 mg/day), high dose ATH-1017 (70 mg/day) or placebo.
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