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Quoin Files IND For QRX003 To FDA In Treatment Of Peeling Skin Syndrome

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Quoin Pharmaceuticals, Ltd. (QNRX), a late clinical-stage pharmaceutical company, announced that it has submitted the Investigational New Drug application, or IND, for QRX003 to the U.S. Food and Drug Administration, or FDA, for the treatment of Peeling Skin Syndrome, or PSS.

The IND submission is based on the encouraging results observed from Quoin's ongoing investigator-led pediatric PSS study. The firm expects to initiate a Phase 2 clinical study for QRX003 in the second half of 2026 after the review results.

Generalised inflammatory PSS is a rare autosomal recessive genodermatosis that is caused by variants of the corneodesmosin gene, or CDSN, which results in excessive shedding of the epidermis. It is characterised by severe pain and chronic pruritus, or itch, to the skin; currently, there is no approved treatment to manage the symptoms.

In the investigator-led pediatric PSS study, QRX003 administered to the initial subject for over 15 months showed significant improvements to skin, sleep patterns, and overall quality of life. Furthermore, the study reported that QRX003 was well tolerated, with no adverse effects observed.

Apart from QRX003, Quoin's key platform product pipeline includes QRX009. Both QRX003 and QRX009 target indications such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, microcystic lymphatic malformations, venous malformations, and Angiofibromas.

"This is a very exciting time for Quoin, with both our QRX003 platform and our QRX009 topical rapamycin platform, targeted to be in clinical testing in the second half of this year," said Michael Myers, CEO of Quoin Pharmaceuticals.

QNRX has traded between $4.55 and $41.8 over the last year. QNRX is currently trading up 0.88% to $4.6.

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