ASHBURN, Va., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a specialty pharmaceutical company focused on rare and orphan diseases, announces additional positive clinical data from its ongoing open-label study evaluating the safety and efficacy of QRX003 as a potential treatment for Netherton Syndrome (NS).

This study, which is being conducted under Quoin’s open Investigational New Drug (IND) application, is an open-label, single-arm trial that is evaluating 10 NS patients dosed with QRX003 over a twelve week period. All subjects in the study are continuing to receive off-label systemic therapy for the duration of the trial.

Of the available data from six evaluable subjects, five demonstrated a well-defined positive improvement in pruritus, or itch, with those five subjects reporting absent or negligible pruritus on completion of dosing with QRX003 based on the endpoint scoring system. The sixth subject’s pruritus was effectively unchanged on completion of dosing with QRX003. In the Investigator assessed skin scoring system, all six patients experienced a improvement in skin appearance, with three of the six subjects demonstrating improvement throughout the study, while for the other three subjects, signs of improvement were exhibited at various points throughout the dosing period. Importantly, all of the 6 subjects indicated a positive impression of QRX003 across a number of key metrics.

The initial safety data across all patients is highly supportive of further product development with no reported treatment related adverse events impacting the study.

Quoin CEO, Dr. Michael Myers, said, “While acknowledging that this is still early stage data, we are very pleased to announce today additional positive results from our ongoing open-label study in Netherton Syndrome. In August of this year, we announced positive data from the first subject, who completed the 12-week dosing period in the study, and I’m now delighted to provide a further positive update for an additional five subjects.

“The results for pruritus are particularly encouraging, as this often causes significant distress for Netherton patients. In addition, there are well defined efficacy signals across the other evaluated endpoints including skin appearance and the subjects’ own impression of how QRX003 performed throughout the study, indicating that QRX003 may have the potential to become an effective treatment for Netherton Syndrome. Furthermore, the absence of any safety concerns from the study to date is a positive indicator for the ongoing clinical development of the product.

“With these results in hand, we are moving into an optimization phase for this study as well as our ongoing double blinded clinical trial and we look forward to providing updated information on this, at the appropriate time.

“Netherton Syndrome is a devastating and sometimes fatal rare disease. Quoin is fully committed to delivering what may have the potential to become the first approved treatment option to this underserved patient population.”

The active ingredient in QRX003 is a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to down-regulate the hyperactivity of skin kallikreins, leading to a more normalized rate of skin shedding. If proven to be safe and effective, long term daily application of QRX003 could lead to the development of a more normally functioning skin barrier and a significant improvement in the quality of life of Netherton patients.

For more information about Quoin’s clinical trials in Netherton Syndrome, please visit: https://www.nethertonsyndromeclinicaltrials.com/