ASHBURN, Va. - Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a company specializing in rare and orphan diseases, has received clearance from the U.S. Food and Drug Administration (FDA) to include teenagers aged 14 and older in its clinical trials for QRX003, a potential treatment for Netherton Syndrome (NS). This marks the first time that non-adult subjects will participate in clinical studies under an open Investigational New Drug Application (IND) for this condition.
The company currently has two ongoing clinical trials for QRX003, which is a topical lotion formulated to normalize the skin shedding process and strengthen the skin barrier in patients with NS. The inclusion of teenagers is expected to expand the eligible participant pool and could accelerate recruitment, leading to a more comprehensive data set.
Dr. Michael Myers, CEO of Quoin, expressed the significance of this development for the Netherton community, highlighting the lack of viable treatment options for the severe hereditary skin disorder. He noted that teens currently receiving off-label systemic therapy could join the open-label study, while those not on such therapy could participate in the placebo-controlled blinded study.
Netherton Syndrome is caused by a mutation in the SPINK5 gene, resulting in severe skin barrier defects, recurring infections, and a predisposition to allergies, asthma, and eczema. Patients also often suffer from severe dehydration, chronic skin inflammation, and stunted growth. There is currently no cure or approved therapeutic treatments for NS.
The information in this article is based on a press release statement from Quoin Pharmaceuticals Ltd.
InvestingPro Insights
As Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) forges ahead with its clinical trials for QRX003, a closer look at the company's financial health and stock performance reveals key insights. According to InvestingPro data, Quoin's market capitalization is currently at $2.73 million USD, reflecting the company's size within the pharmaceutical industry. Despite the potentially groundbreaking nature of their research, the company's P/E ratio, as of the last twelve months ending Q3 2023, sits at -0.32, indicating that investors are not currently expecting earnings growth in the near term.
InvestingPro Tips suggest that while Quoin holds more cash than debt, which could provide financial flexibility, the company suffers from weak gross profit margins and has not been profitable over the last twelve months. Moreover, analysts do not anticipate Quoin will be profitable this year, which may be a concern for potential investors. Additionally, the stock price has experienced significant volatility, with the price having fallen by -41.93% over the last three months and by -52.46% over the last six months.
It's also worth noting that Quoin does not pay a dividend to shareholders, which might be a consideration for those seeking income from their investments. For investors looking for a deeper dive into Quoin's financials and stock performance, there are 11 additional InvestingPro Tips available, providing a more comprehensive analysis of the company. To access these insights, visit https://www.investing.com/pro/QNRX and remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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