New York, March 04, 2024 - PRISM MediaWire - Clinical-stage biotechnology firm Quoin Pharmaceuticals (Nasdaq: QNRX) has obtained FDA clearance to enroll subjects aged 14 years and above into its two ongoing clinical trials for QRX003. These trials are dedicated to assessing QRX003's efficacy in treating Netherton Syndrome (NS). This regulatory approval marks a significant development for Quoin Pharmaceuticals. Consequently, the company's share price surged by 120% during morning trading following the announcement.
Quoin's clinical trials, comprising both a randomized, double-blinded, vehicle-controlled study and an open-label, single-arm trial, are being executed under an open Investigational New Drug Application (IND).
In December 2023, Quoin obtained FDA clearance to enact several protocol amendments to its clinical trials. These modifications, as per the company's statement, are anticipated to yield a more comprehensive data set and potentially expedite approval with a broader label. Key alterations include augmenting the participant count in the blinded trial from 18 to 30 and excluding the lower 2% dose due to the favorable safety profile observed thus far. Furthermore, the number of subjects in the open-label trial is projected to rise from 10 to 20, with a dosing frequency of twice daily.
In October 2023, Quoin disclosed further encouraging clinical findings from its open-label study involving subjects currently undergoing off-label systemic therapy for symptomatic relief. Among the six evaluable subjects, five exhibited a clearly defined positive enhancement in pruritus (itch), while all six patients reported an improvement in skin appearance.
"We are extremely pleased to unveil this significant advancement, which not only benefits Quoin's clinical program but also holds immense promise for the Netherton community at large. We consistently receive requests from parents and caregivers advocating for the inclusion of teen subjects in our clinical studies, owing to the severity of the disease and the limited treatment options available. Today, we are honored to announce that we have obtained FDA clearance to fulfill this need."
Dr. Michael Myers, Chief Executive Officer
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Epidermolysis Bullosa and others. For more information, go to: www.quoinpharma.com.
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