QNRX: Assessing QRX003 For Multiple Conditions; Opening International Netherton Syndrome Clinical Sites

Zacks Small Cap Research

Thu, Aug 22, 2024, 5:05 AM 3 min read

Quoin Pharmaceuticals (NASDAQ:QNRX) has made numerous strides advancing its portfolio of assets to treat various rare and orphaned diseases. The company’s lead asset is QRX003, which currently is being evaluated for the treatment of Netherton Syndrome (NS) in two active studies that are being conducted concurrently in the U.S. The company also intends to expand its clinical trial sites for QRX003 internationally under the open FDA Investigational New Drug (IND) application. A center in Saudi Arabia will be the first international location participating in the study. It is currently treating several NS patients who will now be eligible to participate in Quoin’s studies. The company has hired an experienced CRO (Clinical Research Organization) to manage its clinical development activities in Saudi Arabia.

The company also intends to expand its clinical activities into several EU countries, as well, and has engaged a European CRO to help with those efforts. Quoin has indicated that plans to add new international venues in the study are advanced. With five domestic sites open, the company is optimistic that opening international sites will accelerate overall recruitment activities and diversify the patient population being tested.

QRX003 - Potential to Become 1st Approved Treatment for Netherton Syndrome and Peeling Skin Syndrome…

Quoin is optimistic about QRX003’s prospects to be the first approved treatment for NS. There are no approved NS treatments currently and the overall patient population is fairly sizable. Quoin estimates that there are about 6,000-7,000 patients in the U.S. and EU suffering with Netherton syndrome. Data is not readily available and these estimates are within the range of other published estimates. The National Organization for Rare Disorders (NORD) indicates that the actual number of people suffering from Netherton syndrome might exceed the number of reported cases because it is often undiagnosed.

… as company launches clinical study of QRX003 in Peeling Skin Syndrome

Moreover, in addition to studying QRX003 to evaluate its safety and efficacy in treating NS patients, Quoin intends to study QRX003 for other conditions and earlier this month announced plans to initiate a clinical study in Peeling Skin Syndrome (PSS) to evaluate the safety and efficacy of QRX003 in New Zealand in a pediatric patient with PSS. Most forms of PSS present at birth or during infancy, according to NORD. Symptoms include shedding or peeling of the outermost layer of the skin.

Peeling Skin Syndrome is a rare autosomal disease that has no approved treatment or cure. Quoin believes it has the opportunity to achieve the first regulatory approval for PSS. Quoin has identified the first clinical site and patient and is coordinating with the New Zealand venue to initiate clinical testing quickly. The company is also evaluating additional potential sites in other countries. As noted, the company is also evaluating additional opportunities for QRX003.

Assessing assets for multiple indications can help spread costs over expanded base, broaden target markets upon potential commercialization …

The company’s strategy is to design products to treat multiple indications. 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. Earlier this month the company announced plans to begin a clinical study of QRX003 in Peeling Skin Syndrome (PSS), a rare autosomal disease that has no approved treatment, to evaluate the safety and efficacy of QRX003 in New Zealand in a pediatric patient with PSS. Most forms of PSS present at birth or during infancy, according to NORD. Symptoms include shedding or peeling of the outermost layer of the skin. Quoin believes it has the opportunity to achieve the first regulatory approval for PSS.

By developing its assets for multiple indications, QNRX aims to increase the potential for an expedited regulatory pathway, attain economies of scale on R&D, sales and marketing and other costs and potentially broaden the target market if/when commercial sales launch. Specifically, the strategy is expected to broaden QRX003’s overall target patient populations and commercial prospects, create operating and cost efficiencies and scale and enhance the commercial opportunities of QRX003 and other drugs in the product pipeline.

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