Quoin (NASDAQ:QNRX) Shares on the Move as Company Announces First Clinical Site Open to Evaluate Netherton Syndrome Treatment
In a significant step forward for rare disease treatment, Quoin Pharmaceuticals announced the opening of the first clinical site for its Netherton Syndrome study. The specialty pharma and biotech focused on rare and orphan diseases is well-positioned to potentially deliver the first FDA-approved treatment for the syndrome, a rare and devastating genetic disease with no cure or approved treatment, following on the heels of its recent Investigation New Drug (IND) application clearance from the FDA.
The clinical study will evaluate QRX003 to treat Netherton Syndrome, which leads to severe skin barrier defects, recurring infections, skin cancer, and pruritus among other medical conditions. The topical lotion is designed to create a more normalized skin shedding process leading to a stronger and more effective skin barrier. The randomized, double-blind, vehicle-controlled study will test two doses of QRX003, with opening of additional sites already in process and patient recruitment expected to begin shortly.
The lotion will be applied daily over a 12-week period to patients in contrast with a vehicle lotion. Several clinical endpoints will be assessed in the study.
In the company’s news release, Quoin CEO Dr. Michael Myers noted, “We are very pleased to announce another significant milestone in the development of QRX003 for this very underserved patient population. The opening of this first clinical site, with full Institutional Review Board approval, is testimony to the great work of our CRO, Therapeutics Inc. This is also an important step forward for our partners with whom we have established supply and distribution agreements for QRX003 in 60 countries, as it potentially advances the path to approval in their territories. Furthermore, many of these regions have early-access programs that the data from this study could potentially enable QRX003 to participate in, and be made available on a named patient basis prior to formal regulatory approval.”
Quoin has established relationships with dermatology experts and patient support foundations across the globe to promote extensive access for future marketing plus commercial leverage. With a focus on ensuring every patient, everywhere, can access approved products, the company is targeting regulatory approval in the United States and Europe in 2024, with sales anticipated to reach $262 billion by 2024.
Quoin shares were up more than 10% intra-day, bucking market trend.