Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) submitted an Investigational New Drug application to the U.S. Food and Drug Administration for QRX003 to treat Peeling Skin Syndrome, the company announced. The submission represents what the company described as the first IND application for this rare genetic disorder, which currently has no approved treatment.

The Ashburn, Virginia-based pharmaceutical company plans to initiate a Phase 2 clinical study in the second half of 2026, pending FDA review. The study is expected to recruit 6-8 pediatric and adult patients with PSS in the United States and Europe.

The IND submission was supported by clinical observations from an ongoing investigator-led pediatric PSS study. According to the company, the initial subject has been treated with QRX003 for over 15 months and showed clinical improvements in skin condition, sleep patterns and quality of life. No adverse events were reported during the treatment period.

Peeling Skin Syndrome is a rare autosomal recessive genetic disorder caused by variants of the corneodesmosin gene, resulting in excessive shedding of superficial skin layers. Patients typically experience severe pain and chronic itching. Current management involves over-the-counter emollients.

This marks the second indication for QRX003, which is also being developed for Netherton Syndrome. The company previously submitted the first IND application for Netherton Syndrome treatment.

The information was disclosed in a company press release statement.