Athira Pharma Announces Last Patient Completed LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc recently announced the completion of dosing for the last patient in the Phase 2/3 LIFT-AD clinical trial evaluating fosgonimeton in people with mild-to-moderate Alzheimer’s disease (AD). The company is now targeting to report topline results from the LIFT-AD trial by the end of the third quarter of 2024 and has been invited to discuss the fuller data set during an oral presentation on October 29, 2024, at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place from October 29-November 1, 2024, in Madrid, Spain.

LIFT-AD (NCT04488419) is a randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of fosgonimeton, which is designed to positively modulate the neurotrophic hepatocyte growth factor (HGF) system to protect and preserve neuronal health and function. The trial enrolled approximately 315 patients not on acetylcholinesterase inhibitors (AChEIs) with mild-to-moderate AD to evaluate once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo over a 26-week treatment period. The primary endpoint of LIFT-AD is the change from baseline after 26 weeks of treatment using the Global Statistical Test (GST), a combination of results from measures of cognition (ADAS-Cog11) and function (ADCS-ADL23).

“With patient dosing now complete, we eagerly look forward to the readout of topline results from the LIFT-AD trial, which is targeted by the end of September. The trial’s primary endpoint, GST, will assess the treatment effects of fosgonimeton across multiple aspects of the disease,” said Javier San Martin, MD, Chief Medical Officer of Athira. “Both of the clinical assessments that comprise GST, ADAS-Cog11 and ADCS-ADL23, are widely used in AD trials and are accepted endpoints by the US FDA and other regulatory bodies. Importantly, GST evaluates cognition and function, two key measures of disease progression, which gives us confidence that this endpoint will provide an understanding of the impact of relevant clinical outcomes that fosgonimeton may have in AD. Additionally, the trial will measure serum biomarkers, which will provide insights into the potential neuroprotective mechanism and disease modifying effects of fosgonimeton. We would like to extend our thanks to the investigators, their staff, patients and caregivers involved in the LIFT-AD trial.”

Notably, 85% of eligible clinical trial participants in LIFT-AD and the Phase 2 ACT-AD trial elected to enroll in Athira’s open label extension study (OLEX), which enables participants to either remain on fosgonimeton or, for those in the placebo group, begin fosgonimeton treatment. Currently, more than 70 patients are continuing fosgonimeton treatment beyond 18 months, with nearly 50 patients beyond 2 years, reflecting a long-term participation rate beyond what might be expected in a progressive mild-to-moderate Alzheimer’s disease population.

“We are excited to reach this milestone in the LIFT-AD trial and, more importantly, to be closer to data readout when we hope to demonstrate the potential of fosgonimeton as a differentiated approach to the treatment of Alzheimer’s disease,” said Mark Litton, PhD, President and Chief Executive Officer of Athira. “Patients are in need of better therapies, and we believe that fosgonimeton, acting on the naturally occurring neurotrophic HGF system, offers the potential to be a first-in-class therapeutic that may impact the course of Alzheimer’s disease by activating neuroprotective, neurotrophic and anti-inflammatory pathways in the central nervous system.”

Athira management recently hosted a Key Opinion Leader event focusing on GST, the primary endpoint of the LIFT-AD clinical trial, which Athira believes is a comprehensive measure of overall disease impact and the potential for fosgonimeton to protect and preserve neuronal health in mild-to-moderate AD patients. The webcast event featured presentations from Suzanne Hendrix, Ph.D., Founder and CEO of Pentara Corporation, and Anton P. Porsteinsson, M.D., Director of the University of Rochester Alzheimer’s Disease Care, Research, and Education Program (AD-CARE). A replay of the event can be accessed here.

Fosgonimeton is a potentially first-in-class, once daily, subcutaneously administered small molecule drug candidate. Targeting the protection and repair of neuronal networks, fosgonimeton has disease-modifying potential to address a broad range of neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and dementia with Lewy bodies.

Athira Pharma, Inc., headquartered in the Seattle, WA, area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of therapeutic candidates that modulate the neurotrophic HGF system, including fosgonimeton, which is being evaluated for the potential treatment of mild-to-moderate Alzheimer’s disease in the Phase 2/3 LIFT-AD trial that is targeted to report topline data by the end of the third quarter of 2024. For more information, visit www.athira.com.