Quoin Pharmaceuticals to Include Teen Patients in Rare Disease Clinical Trials
Clinical stage biotechnology company, Quoin Pharmaceuticals (Nasdaq: QNRX) has received FDA clearance to recruit subjects aged 14 years and older into its two ongoing clinical trials for QRX003, which is being evaluated by Quoin in two separate clinical trials for the treatment of Netherton Syndrome (NS). The company’s share price soared 120% in morning trading following the news.
Quoin’s clinical trials, which include a randomized, double blinded, vehicle-controlled study, and an open-label, single-arm trial, are being conducted under an open Investigational New Drug Application (IND).
In December 2023, Quoin received FDA clearance to implement a number of protocol amendments to its clinical trials, which the company said may result in an even more robust data set and potentially more rapid approval with a broader label. The changes include increasing the number of subjects in the blinded trial from 18 to 30, and eliminating the lower 2% dose from the trial as a result of the positive safety profile observed to date. The number of subjects in the open-label trial is expected to increase from 10 to 20, and the dosing frequency will be twice daily.
In October 2023, Quoin announced additional positive clinical data from its open-label study, in subjects who are currently receiving off-label, systemic therapy for symptomatic relief. Five of six evaluable subjects demonstrated a well-defined positive improvement in pruritus (itch), and all six patients experienced an improvement in skin appearance.
Dr. Michael Myers, Chief Executive Officer of Quoin, said, ““We are very pleased to announce this exciting development, not just for Quoin’s clinical program, but for the Netherton community as a whole. We are frequently petitioned by parents and caregivers that teen subjects be allowed to participate in our clinical studies, given the severity of the disease and the absolute dearth of viable treatment options. Today, it is our privilege to announce that we have FDA clearance to do just that.”
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.
