Quoin Pharmaceuticals has dosed the first participant in its ongoing clinical trial of QRX003 to treat Netherton Syndrome.
The double blinded, vehicle-controlled, randomised study is evaluating two different doses of QRX003 topical lotion against a vehicle lotion in these patients.
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It is said to be the company’s first clinical trial which is being conducted under a US Investigational New Drug (IND) application.
The company stated that the test materials are applied once a day to pre-designated areas of the patient’s body over a 12-week period.
Several different clinical endpoints will be evaluated in the study, based on discussions with the US Food and Drug Administration (FDA).
The company unveiled plans in October this year to commence a second study.
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By GlobalDataThis open-label, non-placebo controlled trial has been designed to evaluate the QRX003 topical lotion in Netherton patients who are now receiving off-label treatment, along with systemic therapy for symptomatic relief.
It will assess ten Netherton Syndrome patients for 12 weeks.
The trial will run simultaneously with its ongoing clinical trial and will be conducted at the same sites, as well as by the same clinical investigators.
Quoin CEO Dr Michael Myers said: “With over 70 potential candidates already having gone through our initial screening process, we have been delighted with the level of interest in our clinical programs that has been shown by the Netherton community.
“The dosing of our first patient and the clearance of our second study are big steps forward for Quoin and, hopefully, for the community in general.
“With all six clinical sites on track to be fully opened this month, we are hopeful that the rate of recruitment into both studies will accelerate rapidly going forward.”
