Benzinga | Jan 5, 2022 07:21AM EST

Athira Pharma Provides 2022 Pipeline Outlook

Topline data from ACT-AD Phase 2 Alzheimer's disease study in 2Q22

LIFT-AD Phase 3 Alzheimer's disease study sample size increased to strengthen statistical power of co-key secondary endpoints and enhance the potential for a single pivotal clinical study

Milestones achieved with initiation of SHAPE Phase 2 Parkinson's disease dementia clinical trial and IND filing for ATH-1020

BOTHELL, Wash., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today provided an update on its clinical programs and outlook for 2022.

"Our progress in 2021 provides a strong foundation for an exciting 2022, including topline data from the ACT-AD trial of ATH-1017. Enrollment in the LIFT-AD study continues to exceed industry benchmarks, and to take advantage of this momentum, we are increasing enrollment of mild-to-moderate Alzheimer's disease participants in this study to strengthen the statistical power of key secondary endpoints, which include cognition, function and behavior, with anticipated topline data readout in the first half of 2023," stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira. "We have initiated our SHAPE Phase 2 clinical study of ATH-1017 in Parkinson's disease dementia and Dementia with Lewy bodies. Furthermore this quarter, we will begin a clinical study of ATH-1020, which is targeted for neuropsychiatric diseases."

"While the trial design for LIFT-AD, including the primary composite endpoint Global Statistical Test, remains unchanged, the opportunistic addition of approximately 120 patients strengthens the statistical power of co-key secondary endpoints which we believe enhances the potential for a single pivotal clinical study," said Hans Moebius, MD, PhD, Chief Medical Officer of Athira. "The increased sample size and resulting power for ADAS-Cog11 is based on our original statistical modeling and consistent with the design of previous Phase 3 trials in the treatment of mild-to-moderate Alzheimer's disease. As planned, we will leverage insights from the ACT-AD trial results in the second quarter to optimize the analysis plan for LIFT-AD."

Athira's 2022 Pipeline Outlook: Status and Upcoming Milestones:

ATH-1017 - Small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue.

ACT-AD Phase 2 Study* in mild-to-moderate Alzheimer's disease (NCT04491006)

* Enrollment in ACT-AD completed in October 2021 with 77 participants with mild-to-moderate Alzheimer's disease enrolled across 14 sites in the United States and Australia. The primary endpoint for ACT-AD is Event-Related-Potential (ERP) P300 Latency, a functional measure of working memory processing speed, and secondary endpoints measure cognition, function, and behavior.

* Athira is on track to report top-line data in the second quarter of 2022.

LIFT-AD Phase 3 Study in mild-to-moderate Alzheimer's Disease (NCT04488419)

* Recruitment in the LIFT-AD trial is progressing well, with over 200 participants currently enrolled.

* Athira is increasing the study sample size by approximately 120 participants, from 300 to 420, in order to strengthen the statistical power of co-key secondary endpoints, including ADAS-Cog11.

* Based on the enrollment momentum in this study to-date, the company anticipates enrollment completion in the third quarter of 2022 and to report top-line data in the first half of 2023.

SHAPE Phase 2 Study in mild-to-moderate Parkinson's disease dementia and Dementia with Lewy bodies (NCT04831281)

* Athira initiated the SHAPE trial in the fourth quarter of 2021. SHAPE is a randomized, double-blind, placebo-controlled, parallel-group Phase 2 proof-of-concept study of ATH-1017 in approximately 75 participants with mild-to-moderate Parkinson's disease dementia or Dementia with Lewy bodies.

* The company expects to dose the first patient in the SHAPE Phase 2 study in the first quarter of 2022.

ATH-1020 - Orally available, small brain-penetrant molecule designed to enhance the HGF/MET system, as a potential treatment candidate for neuropsychiatric indications.

Phase 1 Study in Healthy Volunteers (NCT05169671)

* Athira submitted an Investigational New Drug application for ATH-1020 in the fourth quarter of 2021. The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of ATH-1020 in approximately 68 healthy young and elderly volunteers.

* The company expects to dose the first volunteer in the study in the first quarter of 2022.

*The ACT-AD trial is supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.