Quoin Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for QRX003, enabling it to initiate a Phase II clinical trial for a treatment for Peeling Skin Syndrome (PSS).
The trial is expected to begin in the second half of 2026. Potential clinical sites and investigators, as well as prospective study participants, have already been identified.
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It will enrol between six and eight paediatric and adult patients living with PSS in both the US and Europe.
Participants will receive twice-daily application of QRX003 to more than 80% of their body surface area for 52 weeks.
Quoin Pharmaceuticals is targeting approval of QRX003 for the treatment of PSS in 2028.
The topical serine protease inhibitor lotion is already being evaluated for Netherton Syndrome, and PSS is now the second indication to receive IND clearance for the candidate.
In an ongoing investigator-initiated paediatric study of QRX003, subjects have experienced clinically meaningful improvements by 12 weeks.
Improvements were noted in measures such as the modified ichthyosis area severity index (M-IASI), investigator’s global assessment (IGA), and the children’s dermatology life quality index (CDLQI).
The treatment is continuing beyond 15 months with no reported adverse events.
Quoin Pharmaceuticals CEO Dr Michael Myers said: “For families living with Peeling Skin Syndrome, there is still no approved treatment and no other active clinical development of a potential treatment for the disease. This is what makes FDA clearance to initiate our Phase II study so meaningful for this community.
“We are excited to start this Phase II study of QRX003 and take yet another step toward developing a treatment for another disease that has long been overlooked. This is now the second rare dermatologic indication for QRX003, and it fully reflects Quoin’s mission to provide hope to patient communities and families where none has previously existed.
“We are particularly encouraged by the FDA expressing no safety concerns in terms of study design and dosing duration, which we believe is a very positive indicator as we seek to reach alignment with the agency for our upcoming Phase III study in Netherton Syndrome.”
PSS is a rare genetic disorder affecting the epidermis, causing excessive skin shedding, pain, and chronic itch.
