HOUSTON - Coya Therapeutics, Inc. (NASDAQ: COYA), a biotech firm focusing on treatments to enhance regulatory T cell function, has concluded a Phase 2 trial investigating LD IL-2 for mild-to-moderate Alzheimer's disease (AD).
The study, conducted by Houston Methodist Hospital and funded by the Gates Foundation and the Alzheimer's Association, aims to assess the safety, tolerability, and biological activity of the drug compared to a placebo.
The research involved 38 patients who received either LD IL-2 at varying dosages or a placebo over a 21-week treatment period, followed by a nine-week follow-up. Preliminary data from an earlier open-label study suggested that LD IL-2 could significantly improve cognitive function and increase regulatory T cell (Treg) numbers and function in AD patients.
President and CMO of Coya Therapeutics, Fred Grossman D.O., expressed optimism about the study's contribution to the company's pipeline for dementia treatments. The company anticipates releasing top-line results from this study in the summer of 2024.
In the initial study, patients showed a notable enhancement in mean Mini-Mental State Examination (MMSE) scores during the treatment phase. Moreover, there was no significant cognitive decline as measured by other validated instruments. The treatment was generally well tolerated, with mild injection-site reactions and leukopenia being the most common adverse events.
Alzheimer's disease, which accounts for a majority of dementia cases, affects an estimated 5.7 million Americans. Symptoms typically emerge after age 60 and the risk doubles every five years beyond age 65. This progressive disease can lead to severe cognitive impairment, making it a leading cause of death among older adults.
Coya Therapeutics is developing COYA 302, a combination therapy aimed at enhancing Treg function and reducing inflammation, which is being explored for various neurodegenerative diseases. COYA 302 has not yet received approval from the FDA or other regulatory agencies.
This article is based on a press release statement from Coya Therapeutics, Inc.
InvestingPro Insights
Coya Therapeutics, Inc. (NASDAQ: COYA) has been a company of interest for investors, particularly as it explores innovative treatments for Alzheimer's disease. As the biotech firm awaits the results of its Phase 2 trial, here are some key financial metrics and InvestingPro Tips to consider.
With a market capitalization of $126.2M, Coya Therapeutics is a small-cap company that has shown significant movement in its stock price. The company's shares have experienced a large price uptick over the last six months, with a 64.68% return, and an impressive 73.64% return over the last year. This performance indicates a strong market confidence in the potential of the company's pipeline products, including the much-anticipated COYA 302.
Investors should note that Coya Therapeutics holds more cash than debt on its balance sheet, which is a positive sign for financial stability. Additionally, the company’s liquid assets exceed its short-term obligations, suggesting that it has a solid footing to manage its current liabilities and invest in its research and development activities.
Still, it is important to consider that analysts anticipate a sales decline in the current year, and the company is not profitable over the last twelve months, with a negative P/E ratio of -9.3. The gross profit margin stands at 10.24%, indicating challenges in profitability and cost management.
These financial health indicators are crucial for investors to monitor as they evaluate the company's long-term viability and potential for future growth.
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