By M. Marin

NASDAQ:QNRX

READ THE FULL QNRX RESEARCH REPORT

Progressing studies of QRX003; positive interim clinical data

Quoin Pharmaceuticals (NASDAQ:QNRX), a clinical stage, specialty pharmaceutical company that focuses on developing treatments for rare and orphan diseases, is expanding clinical activities studying lead asset QRX003 for the treatment of Netherton Syndrome (NS). Quoin has active NS studies that are being conducted concurrently under an open Investigational New Drug (IND) application with the FDA. The company believes it is the only development company developing treatment for NS that is conducting dual studies concurrently under an open IND application.

The concurrent open-label study clinical studies has yielded positive interim results. Quoin believes the data generated to-date from its ongoing open-label and other studies has shown evidence that QRX003 can contribute to improvement across all measured clinical endpoints. The company expects its clinical activities will produce a solid database that will be key to its regulatory approval submission supporting the safety and efficacy of QRX003. Moreover, no adverse events (AEs) have been reported to-date.

New study represents most extensive clinical application of QRX003 thus far

QNRX is also assessing QRX003 in an NS pediatric patient in an Investigator Pediatric NS study, with plans to enroll additional pediatric patients at other sites. Clinical assessment of QRX003 in a pediatric patient is being led by Dr. Alan Irvine, a professor of dermatology at Trinity College Dublin and a Consultant Dermatologist at Children’s Health Ireland. Dr. Irvine is also the president of the International Eczema Council and an elected member of the Royal Irish Academy. He has authored more than 250 peer-reviewed papers published in medical journals. QNRX expects to broaden the scope of this clinical assessment to include three additional pediatric patients in Spain.

Treating pediatric patients is important, as early treatment is critical to managing the disease. The company also commenced measures to expand clinical activities on QRX003 internationally. According to QNRX, an estimated up to 20% of infants born with NS do not survive.

In December 2024, Quoin received FDA clearance to initiate a new investigator led whole-body clinical study for QRX003, which will be led by Dr. Amy Paller, a pediatric dermatologist and clinical researcher at Northwestern University. The study will evaluate the safety and efficacy of twice-daily application of QRX003 to more than 80% of the body surface area in NS patients. This application is what the company would anticipate in real-world usage if QRX003 obtains regulatory approval. The company noted that it represents the most extensive clinical application of QRX003 thus far.

As QNRX continues to expand its clinical activities as it seeks to develop a database supporting the safety and efficacy of QRX003 in treating NS and other diseases, the company expects its cash / equivalents balance to be sufficient to fund operations into 2Q26 and remains optimistic about QRX003’s prospects to be the first approved treatment for NS.

Broadening potential target markets by assessing assets for multiple indications

Moreover, the company’s strategy is to design products to treat multiple indications. This strategy has multiple advantages, we believe, including helping to spread R&D costs over an expanded patient population and potentially broadening the commercial prospects upon potential commercialization. Reflecting this strategy, QNRX intends to study QRX003 for several conditions and build a database supporting its efficacy and safety as a treatment for a range of dermatological conditions, including a clinical study of QRX003 in Peeling Skin Syndrome (PSS), a rare autosomal disease that has no approved treatment.

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