FDA Grants First-Ever Fast Track Designation for Peeling Skin Syndrome to Quoin's QRX003
核心洞察
The FDA granted Fast Track Designation to Quoin Pharmaceuticals' topical serine protease (搜索) inhibitor lotion QRX003 for Peeling Skin Syndrome (搜索), the first such designation for the disease.
It is the second Fast Track Designation for QRX003, following the March 11, 2026 designation for Netherton Syndrome (搜索), and follows July 2026 clearance of the first-ever PSS IND.
Quoin plans to start a Phase 2/3 study in the second half of 2026 enrolling up to 12 pediatric and adult patients in the United States and Europe.
Quoin Pharmaceuticals announced on Sept. 22, 2026 that the U.S. Food and Drug Administration has granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome (搜索) (PSS). The designation is the first ever granted for a Peeling Skin Syndrome therapy, and it is the second Fast Track Designation for QRX003, an investigational topical serine protease (搜索) inhibitor lotion.
The FDA previously granted Fast Track Designation to QRX003 lotion (4%) for Netherton Syndrome (搜索) on March 11, 2026. The new designation follows FDA clearance in July 2026 of Quoin's Investigational New Drug application for QRX003 in PSS. Quoin submitted that IND on June 2, 2026, and it was the first IND ever submitted to the FDA for the disease.
"This is an important regulatory milestone for QRX003 and for a community that today has no approved treatment," said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. "Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome (搜索), that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease."
Development Program and Dosing
Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome (搜索) in the second half of 2026. The study is expected to enroll up to 12 pediatric and adult patients in the United States and Europe. In the trial, QRX003 will be applied twice daily to more than 80% of patients' body surface area over a 48-week period, with an interim data review at 24 weeks. Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028.
The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study in a single subject. The subject has achieved improvements across key objective severity endpoints, including the Modified Ichthyosis Area Severity Index (M-IASI), Investigator's Global Assessment (IGA), as well as pruritus and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing and has continued for more than 15 months, with no adverse events reported.
Disease Background
Generalized inflammatory peeling skin syndrome (搜索) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (搜索) (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. There is currently no approved treatment for PSS.
Regulatory Context
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.
QRX003 is in late-stage development for Netherton Syndrome (搜索) and other orphan skin diseases. It has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the FDA, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. For Peeling Skin Syndrome (搜索), QRX003 has been granted Rare Pediatric Disease and Fast Track Designation by the FDA. QRX003 lotion (4%) is currently being evaluated in Phase 2/3 whole-body clinical trials in patients with Netherton Syndrome.
Quoin is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. Its pipeline is focused on two platform products, QRX003 and QRX009 (搜索), which collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome (搜索), Peeling Skin Syndrome (搜索), Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations and Angiofibromas.