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BOTHELL, Wash. - Athira Pharma, Inc. (NASDAQ: ATHA), a biopharmaceutical company engaged in developing treatments for neurodegenerative diseases, announced that its LIFT-AD clinical trial of fosgonimeton did not meet its primary endpoint. The trial aimed to evaluate the efficacy of fosgonimeton, a hepatocyte growth factor modulator, in patients with mild-to-moderate Alzheimer's disease over a 26-week period.
The primary endpoint was the Global Statistical Test (GST), which combined measures of cognition and function. Key secondary endpoints included the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) and the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL23). None of these endpoints reached statistical significance when compared to placebo.
However, in pre-specified subgroups of patients with moderate Alzheimer's or those who are APOE4 gene carriers, there was a greater numerical treatment effect observed. Additionally, fosgonimeton treatment showed consistent directional improvements across biomarkers associated with Alzheimer's disease pathology, which aligns with the neuroprotective mechanism of hepatocyte growth factor modulation.
Despite the trial not meeting its primary goals, Athira's Chief Medical Officer, Dr. Javier San Martin, expressed belief in the potential of HGF pathway modulation to improve neuronal health and mitigate disease progression. Dr. Anton P. Porsteinsson, a LIFT-AD investigator, also found the biomarker and subgroup data consistent with the drug's expected mechanism of action.
Fosgonimeton was generally well-tolerated, with a favorable safety profile. The majority of treatment-emergent adverse events were related to injection site reactions. The incidence of serious adverse events was similar between the treatment and placebo groups.
Athira is also developing ATH-1105, an orally administered small molecule for potential treatment of amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, which is currently undergoing a Phase 1 clinical trial.
The full analysis of the LIFT-AD results will be reviewed at the upcoming 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) in Madrid, Spain. Athira management will host a live webcast to discuss the LIFT-AD topline results.
This news is based on a press release statement and reflects the latest developments from Athira Pharma regarding their clinical trial outcomes.
In other recent news, Athira Pharma has shared promising preclinical data at the Alzheimer's Association International Conference 2024. The data indicates that its drug candidate, fosgonimeton, may have potential in treating Alzheimer's disease. The drug has shown potential in reducing Alzheimer's disease-related protein pathology and protecting neurons from amyloid-β toxicity. The compound is currently under evaluation in the Phase 2/3 LIFT-AD clinical trial, with results anticipated by the end of the third quarter of 2024.
In addition to these developments, Athira Pharma has also reached a preliminary settlement in a shareholder derivative lawsuit. The terms of the settlement include the implementation of corporate governance reforms and the coverage of legal fees and expenses.
These recent developments underscore Athira Pharma's commitment to advancing its pipeline of therapeutic candidates, including fosgonimeton. However, it is important to note that the efficacy and safety of fosgonimeton are still under investigation in clinical settings.
InvestingPro Insights
Athira Pharma (NASDAQ: ATHA), while facing challenges in its LIFT-AD clinical trial, shows a financial position that investors may want to consider. According to InvestingPro data, Athira has a market capitalization of $110.32 million, which reflects the company's valuation in the biopharmaceutical industry. The company's Price to Book ratio, as of the last twelve months leading up to Q2 2024, stands at 1.31, which can provide an indication of how the market values the company's assets relative to its share price.
InvestingPro Tips highlight that Athira holds more cash than debt on its balance sheet, suggesting a level of financial stability that could be reassuring to investors. However, the company is quickly burning through cash, which is a critical factor for investors to monitor, especially in the biopharmaceutical sector where research and development costs can be substantial. Investors should note that analysts do not anticipate the company will be profitable this year, and Athira does not pay a dividend to shareholders, which may influence investment decisions for those seeking immediate returns or income.
Despite recent setbacks, Athira has experienced a strong return over the last three months, with a 21.18% price total return. This performance indicates some investor confidence in the company's long-term prospects, even as it navigates the complexities of drug development. For those considering an investment in Athira Pharma, additional InvestingPro Tips are available, which can provide further insights into the company's financial health and market performance.
For a more comprehensive analysis and additional tips on Athira Pharma, investors can visit InvestingPro where more than 9 additional tips are listed to help inform investment decisions.
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