Announcement • Jul 09
Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2 Study of QRX003 in Peeling Skin Syndrome Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for QRX003 for the treatment of Peeling Skin Syndrome (PSS), enabling initiation of its planned Phase 2 clinical study. Clearance enables Quoin to initiate a Phase 2 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026. The study is expected to enroll 6-8 pediatric and adult patients in the United States and Europe. The IND is the first ever submitted to the FDA for Peeling Skin Syndrome, and its clearance now enables the first company-sponsored formal clinical study for the disease to be conducted. PSS is the second IND cleared indication for QRX003, in addition to Netherton Syndrome. In an ongoing investigator-led pediatric study, subject achieved clinically meaningful improvements by 12 weeks across key objective severity endpoints Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global Assessment (IGA) and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing and after continued dosing with QRX003 for over 15 months, no adverse events have been reported. FDA expressed no safety concerns regarding study design and duration of dosing. Quoin submitted the IND on June 2, 2026, and received FDA clearance in July 2026. The Phase 2 study is expected to recruit 6-8 pediatric and adult patients with PSS in both the United States and Europe. In the Phase 2 study, QRX003 will be applied twice-daily to greater than 80% of the patients’ body surface area (BSA) over a 52-week period. The Company is targeting the approval of QRX003 as a potential treatment for PSS in 2028. Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS. QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. QRX003 is also being evaluated for the treatment of Peeling Skin Syndrome. Announcement • Jul 07
Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026 Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026. Location: at the offices of blank rome llp, one logan square, pa 19103., philadelphia United States Announcement • Jul 01
Quoin Pharmaceuticals Receives Notice Of Allowance For Patent Covering Combination Treatment For Netherton Syndrome Quoin Pharmaceuticals Ltd. has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.” The patent supports Quoin’s intellectual property strategy for QRX003, its investigational treatment for Netherton Syndrome, a rare genetic skin disease for which there are currently no approved treatments. The USPTO has issued a Notice of Allowance for U.S. Patent Application No. 18/428,570, titled “Combination Treatment for Netherton Syndrome.” The allowed claims cover a method of treating Netherton Syndrome using a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients carrying SPINK5 mutations, the genetic basis of Netherton Syndrome. The patent will be granted following payment of the issue fee. QRX003 (QYLEKI™), Quoin’s investigational topical treatment for Netherton Syndrome, holds Orphan Drug, Rare Pediatric Disease, and Fast Track designations in the United States and Orphan Drug Designation in the European Union and Japan. If approved, QRX003 has the potential to become the first approved treatment for Netherton Syndrome. The allowed claims cover a method of treating Netherton Syndrome by administering a topical serine protease inhibitor, dipalmitoyl hydroxyproline, together with an anti-inflammatory agent. The claims include treatment of patients who carry mutations in the SPINK5 gene, the genetic basis of the disease, and cover application to skin lesions on the arms and lower legs. The allowed claims add to Quoin’s intellectual property position around its topical treatment approach for Netherton Syndrome and support the Company’s long-term commercialization strategy for QRX003. The Notice of Allowance indicates that the application has completed substantive examination and is expected to proceed to issuance following payment of the required fees. Once granted, the patent will add to the Company’s intellectual property position in the United States covering its Netherton Syndrome program. Netherton Syndrome is a rare, serious genetic skin disease caused by mutations in the SPINK5 gene. The condition is characterized by impaired skin barrier function, persistent inflammation, and increased serine protease activity in the skin. There are currently no approved therapies in the United States indicated specifically for Netherton Syndrome. QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan. The U.S. brand name QYLEKI™ has been accepted by the FDA. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. 
