BRANFORD, Conn. - Azitra, Inc. (NYSE American: AZTR), a biopharmaceutical company specializing in precision dermatology, has announced the commencement of a Phase 1b clinical trial for its drug candidate ATR-12, aimed at treating Netherton syndrome. The trial has begun dosing its first patient, marking a significant step in the development of this potential new therapy.
The company's clinical trial is set to enroll approximately 12 adult patients, who will receive twice-daily treatments over the course of 14 days. The primary focus of the study is to evaluate the safety and tolerability of ATR-12, with secondary and exploratory objectives aimed at assessing efficacy signals and biomarkers. Azitra anticipates releasing interim safety data in early 2025, with comprehensive results expected in the latter half of the same year.
ATR-12, Azitra's leading drug candidate, is an engineered strain of Staphylococcus epidermidis that has been modified to produce therapeutic levels of a LEKTI protein subunit. This protein is crucial for individuals with Netherton syndrome, a chronic genetic skin condition that can be life-threatening due to the absence of the LEKTI protein in affected patients.
Francisco Salva, CEO of Azitra, expressed the company's enthusiasm about entering this new phase of clinical research, highlighting the importance of this milestone for both Azitra and patients afflicted with Netherton syndrome. Mary Spellman, MD, and acting CMO of Azitra, also conveyed optimism regarding the trial's potential to pave the way for future treatments, particularly in pediatric cases and over extended treatment durations.
The Phase 1b trial is a multicenter, randomized, double-blind, vehicle-controlled study. It involves the application of 109 CFU/g of ATR-12 or a vehicle control on opposite sides of the body. The study's primary objective is to assess the safety and tolerability of the topical application of ATR-12, while also evaluating efficacy signals and the skin pharmacokinetics of the LEKTI subunit.
Azitra, Inc. is at the forefront of developing innovative therapies for dermatological conditions, leveraging a proprietary platform that includes a microbial library and the use of AI and machine learning to screen for therapeutic characteristics.
The information in this article is based on a press release statement from Azitra, Inc.
In other recent news, Azitra Inc., a clinical-stage biopharmaceutical company, has been making significant strides in its ongoing research and development efforts. The company recently received FDA clearance for a Phase 1/2 clinical trial of ATR-04, a potential treatment for skin rash associated with certain cancer therapies. Furthermore, Azitra has secured patents in the U.S., Canada, and China for a filaggrin-secreting strain of Staphylococcus epidermidis, aimed at treating atopic dermatitis and other skin conditions.
In a move to restructure its capital, Azitra also executed a 1-for-30 reverse stock split of its common stock, reducing the number of its shares in circulation. Meanwhile, the company continues to advance its product candidates ATR-04 and ATR-12, with plans to submit an Investigational New Drug application to the FDA for a Phase 1b clinical trial for ATR-04.
These recent developments highlight Azitra's commitment to precision dermatology and its efforts to address unmet medical needs in skin disease treatment. The company's progress is marked by its robust intellectual property portfolio, its strategic restructuring, and its ongoing clinical trials.
InvestingPro Insights
As Azitra, Inc. (NYSE American: AZTR) embarks on the Phase 1b clinical trial of ATR-12, potential investors and stakeholders are closely observing the company's financial health and market performance. The latest data from InvestingPro paints a detailed picture of the company's current financial landscape.
InvestingPro data indicates a market capitalization of $5.38 million, reflecting the market's valuation of the company. Despite this, Azitra is facing challenges, as evidenced by a negative P/E ratio of -0.04, signaling that the company is not currently generating profits. Additionally, the company's revenue for the last twelve months as of Q2 2024 stands at $0.41 million, with a substantial gross profit margin of 100%. However, the company's operating income margin during the same period is notably negative at -2511.47%, highlighting significant operational costs relative to its revenue.
InvestingPro Tips suggest caution, noting that Azitra is quickly burning through cash and operates with a moderate level of debt, which could pose risks to financial stability. Moreover, the stock has experienced high price volatility, and analysts do not anticipate the company will be profitable this year. These factors are crucial for investors to consider, especially in the context of the company's ongoing clinical trials and the potential for future growth.
For those interested in a deeper analysis, InvestingPro offers additional insights, with a total of 13 tips available on the platform, providing a comprehensive look at the company's financial health and market prospects.
It's important for investors to weigh these financial metrics and InvestingPro Tips against the company's scientific advancements. While the clinical development of ATR-12 could offer long-term value, the current financial data and expert analysis provide a sobering counterbalance to the optimism surrounding the trial's progress.
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