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Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, presented results from its Phase 1 clinical trial of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference in Dallas, Texas. ALS Nexus convenes leading experts from the ALS community, including researchers, healthcare professionals, advocates and individuals living with amyotrophic lateral sclerosis (ALS), to connect and learn about advances in research, clinical care and advocacy.
ATH-1105 is the Company's novel, orally available, CNS-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for the potential treatment of neurodegenerative diseases, including ALS.
"The advancement of new treatment options for ALS is of vital importance to help prolong survival and improve quality of life of people living with ALS, and we are excited to be developing a potential novel approach with ATH-1105," said Javier San Martin, M.D., Chief Medical Officer at Athira. "Our Phase 1 safety, tolerability, and pharmacokinetic data are encouraging and support continued development of ATH-1105."
Results from the Phase 1 trial of ATH-1105 demonstrated a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration. ATH-1105 has also demonstrated consistent and robust beneficial effects in preclinical models of ALS.
The clinical data were highlighted in a poster presentation titled, "Safety, Tolerability, and Pharmacokinetics of ATH-1105 in Health Volunteers," presented by Kai-Bin Ooi, Director, Drug Development and Operations at Athira Pharma.
About the ATH-1105 Phase 1 Clinical Trial
The first-in-human Phase 1 ( NCT06432647 ) double-blind, placebo-controlled clinical trial enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The trial was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes. The results of the Phase 1 trial showed that ATH-1105 demonstrated a favorable safety profile and was well-tolerated in healthy volunteers, supporting continued clinical development.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a 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 drug candidates that modulate the neurotrophic HGF system. For more information, visit w ww.athira.com . You can also follow Athira on Facebook , LinkedIn , X and Instagram .
Forward-Looking Statements
This communication contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Athira's drug candidates as potential treatments for amyotrophic lateral sclerosis and other neurodegenerative diseases; future development plans and the timing thereof; the potential learnings from preclinical studies and other nonclinical data and their ability to inform and improve future clinical development plans; the implications of learnings from our Phase 1 ATH-1105 clinical trial for future development plans, including the timing and our plans to investigate ATH-1105 in a future clinical trial in people living with ALS either by us or in conjunction with a partner; expectations regarding the potential efficacy and commercial potential of Athira's drug candidates; Athira's ability to advance its drug candidates into later stages of development; and Athira's plans and expectations regarding Athira's exploration of strategic alternatives and partnering options. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "on track," "would," "expect," "plan," "believe," "intend," "pursue," "continue," "suggest," "potential," "target," and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira's drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; whether Athira's trials are sufficiently powered to meet the planned endpoints; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that may in the future be instituted against Athira, its directors and officers; possible negative interactions of Athira's drug candidates with other treatments; FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA and SEC, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; Athira's assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets, including as a result of tariffs; the impact of competition; the impact of drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; risks related to Athira's exploration of strategic alternatives; as well as the other risks detailed in Athira's filings with the Securities and Exchange Commission from time to time. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
