MIAMI - Avenue Therapeutics, Inc. (NASDAQ:ATXI), a specialty pharmaceutical company, has announced preclinical data suggesting that its investigational drug BAER-101 could effectively suppress seizures in a model of absence epilepsy. The findings, published in Drug Development Research, indicate that BAER-101 targets specific GABAA receptor subtypes, which may lead to improved treatment outcomes for epilepsy patients while reducing the risk of tolerance and abuse associated with current medications.
The study utilized the Genetic Absence Epilepsy Rats from Strasbourg (GAERS) model, a standard and reliable animal model for anti-seizure drug development. BAER-101 demonstrated a full suppression of seizure activity at a minimal effective dose of 0.3 mg/kg. Importantly, the compound was shown to be selective for GABAA α2 and α3 subtypes, avoiding the α1 and α5 subtypes that are commonly associated with side effects such as dizziness, somnolence, and cognitive impairment.
Avenue's CEO, Alexandra MacLean, M.D., noted the significance of the findings, emphasizing the potential of BAER-101 to meet the unmet need for a safe and effective epilepsy treatment. The drug's safety profile has been substantiated in over 700 patients and healthy volunteers, supporting its advancement to a Phase 2a clinical trial.
Subject to securing necessary funding, potentially through a strategic partnership, Avenue plans to initiate this clinical trial to further evaluate BAER-101's anti-seizure properties in patients with common or rare epilepsies. This step is crucial as epilepsy affects approximately 65 million people worldwide, and current treatments often come with undesirable side effects and the risk of drug resistance.
Avenue Therapeutics is actively developing a portfolio of treatments for neurologic diseases, including BAER-101 for central nervous system disorders and other assets in various stages of clinical development. The company, founded by Fortress Biotech, Inc. (NASDAQ:FBIO), is headquartered in Miami, Florida.
The announcement is based on a press release statement.
InvestingPro Insights
Avenue Therapeutics, Inc. (NASDAQ:ATXI) has been making strides in the development of its investigational drug BAER-101, aiming to address the significant global challenge of epilepsy treatment. While the clinical potential of BAER-101 is promising, it's important for investors to consider the financial health and market performance of ATXI. According to the latest metrics from InvestingPro, Avenue Therapeutics is currently grappling with a challenging financial landscape.
The company's market capitalization stands at a modest 5.57 million USD, reflecting investors' current valuation of the company. However, the financial data indicates some potential concerns. With an adjusted P/E ratio for the last twelve months as of Q3 2023 at -0.53, it suggests the company is not generating profit relative to its share price. This is further underscored by a significant operating loss of 16.33 million USD during the same period. Moreover, the stock's performance has been notably poor, with an 87.12% decline in the one-year price total return.
InvestingPro Tips for ATXI highlight the stock's high price volatility and its tendency to move in the opposite direction of the market. This could be a critical consideration for investors who are looking for stability in their portfolio, especially in a market that is increasingly sensitive to both macroeconomic factors and industry-specific news. Additionally, analysts have voiced concerns regarding the company's profitability, indicating that Avenue Therapeutics may not achieve profitability this year.
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