BRANFORD, Conn. - Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company, announced promising preclinical data for its product candidate ATR-04, aimed at treating skin toxicity caused by epidermal growth factor receptor inhibitors (EGFRi). The findings were presented today at the Society of Investigative Dermatology (SID) 2024 Annual Meeting in Dallas, Texas.
The company's research indicates that ATR-04, a live biotherapeutic product, can significantly reduce the presence of methicillin-resistant Staphylococcus aureus (MRSA) on skin models. In the studies, ATR-04 treatment resulted in a 96% reduction in MRSA on in vitro skin models and approximately a 99% reduction on ex vivo pig skin.
Moreover, the treatment has shown to lower levels of IL-36γ, a pro-inflammatory cytokine associated with EGFRi-induced skin toxicity, by 75% in human skin models treated with the EGFRi erlotinib. Furthermore, the product candidate increased the production of human beta defensin, a key antimicrobial peptide, by 18-fold compared to a control vehicle.
Travis Whitfill, Azitra's co-founder and COO, stated that these preclinical results support the company's plans to submit an Investigational New Drug (IND) application to the FDA for a Phase 1b clinical trial. The company is looking to expand its clinical-stage pipeline with ATR-04 later this year.
ATR-04 consists of a strain of S. epidermidis that has been engineered for safety by deleting an antibiotic resistance gene and inducing auxotrophy to control its growth. This strain is being developed to address skin toxicity, a condition affecting roughly 150,000 patients in the United States, which is characterized by weakened skin immunity, inflammation, and often elevated levels of IL-36γ and S. aureus due to EGFRi treatment.
Azitra's approach to precision dermatology includes a proprietary platform with a microbial library of approximately 1,500 unique bacterial strains. The platform leverages artificial intelligence and machine learning to screen for therapeutic characteristics.
This press release includes forward-looking statements and acknowledges that actual results could significantly differ from those projected. The company cautions that further preclinical trial data may not align with initial results and that its IND application for ATR-04 may not be approved by the FDA. The information presented is based on a press release statement.
InvestingPro Insights
As Azitra, Inc. (NYSE American: AZTR) advances its clinical pipeline with the promising candidate ATR-04, investors are closely monitoring the financial health and market performance of the company. Recent data from InvestingPro provides a snapshot of Azitra's current financial position:
- The company's market capitalization stands at a modest $5.71 million, reflecting investor valuation of the business.
- Azitra's price-to-book ratio for the last twelve months as of Q1 2024 is 1.32, which offers an insight into how the market values the company's net assets.
- Despite significant revenue growth of 106.53% in the same period, the company's operating income margin is deeply negative at -1574.85%, indicating substantial operational costs relative to revenue.
InvestingPro Tips highlight some key considerations for investors:
- Azitra holds more cash than debt on its balance sheet, which suggests a solid liquidity position that could support ongoing research and development efforts.
- However, analysts are not optimistic about the company's profitability in the short term, as they do not anticipate Azitra will be profitable this year.
Investors interested in a deeper dive into Azitra's financials and market performance can discover over 5 additional InvestingPro Tips on InvestingPro. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing a comprehensive analysis that can guide investment decisions.
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