ACT-AD Phase 2 Trial Fully Enrolled with Results Expected Next Year

Yedida Y Bogachkov PhD avatar

by Yedida Y Bogachkov PhD |

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Athira Pharma has completed enrollment in its ACT-AD Phase 2 trial evaluating the safety and efficacy of ATH-1017 in adults with mild-to-moderate Alzheimer’s disease.

“The completion of enrollment in our ACT-AD trial is an important step forward in advancing ATH-1017 as a potential new treatment option for patients suffering from Alzheimer’s and other dementias,” Mark Litton, PhD, Athira president and CEO, said in a press release.

“As part of our overall clinical development program to maximize the full potential of ATH-1017, we plan to initiate a clinical trial in Parkinson’s disease dementia later this year,” he added.

Topline results of the ACT-AD trial (NCT04491006) are expected to be available in the first half of 2022.

ATH-1017 is a small molecule designed to improve the effects of hepatocyte growth factor and its receptor, MET, which are expressed throughout the central nervous system (brain and spinal cord). Athira hopes that ATH-1017 can help promote brain health and function.

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The investigational compound (also known as NDX-1017) is being tested in the LIFT-AD Phase 2/3 trial (NCT04488419) and was shown to be able to regenerate nerve cells and improve cognitive function in previous studies.

“By focusing on neuronal network recovery, ATH-1017’s novel mechanism of action is agnostic to the underlying disease pathology of Alzheimer’s and other dementias,” said Hans Moebius, MD, PhD, chief medical officer at Athira.

The ACT-AD trial has enrolled 77 patients with mild-to-moderate Alzheimer’s across 14 sites in the U.S. and Australia. Patients will be given a placebo or a high (70 mg/day) or low (40 mg/day) dose of ATH-101, as a subcutaneous (under-the-skin) injection, over the course of 26 weeks.

Patients will be evaluated for improvement in cognition, as well as global and function assessments. Additionally, electroencephalogram, quantitative electroencephalogram, and Event-Related-Potential (ERP P300), a functional measure of working memory processing speed, will be used to assess brain function.

After the 26-week treatment, patients may choose to continue to the open label extension trial and receive ATH-1017 at the high dose for an additional 26 weeks.

“The completion of enrollment in ACT-AD is an important clinical milestone for Athira,” Moebius said. “Results from this trial may provide Athira with supportive information that can help optimize our ongoing potentially pivotal LIFT-AD trial and confirm the statistically significant improvement in P300 latency, a functional measure of working memory processing speed, demonstrated in our early trial.”