QNRX - FDA Clears Quoin Pharmaceuticals to Recruit Teen Subjects into Its Ongoing Netherton Syndrome Clinical Studies

2024-03-04 09:06:31 ET

DENVER, Colo., Mar 04, 2024 ( 247marketnews.com )- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX ) reported, this morning, that the U.S. Food and Drug Administration (FDA) cleared the Company to recruit teen subjects aged 14 years and older into its two ongoing clinical trials for QRX003, which is being developed as a potential treatment for Netherton Syndrome (NS). Both trials are being conducted under Quoin’s open Investigational New Drug Application (IND) for QRX003.

Quoin is trading at $5.17, up $2.3999 (+86.64%), on trading volume of 4.3M shares.

This morning’s premarket high is $7.6297 and its 52-week range is $2.2507 to $12.00.

This morning’s volume is tracking to very likely set a new all-time high and already surpassed its 987.22k shares outstanding and 967.52k shares in the float.

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.

“This FDA clearance represents the very first time that non-adult Netherton subjects will be tested in clinical studies conducted under an open-IND and, as such, represents a very significant and important step forward for members of this community. Significantly, teens who are currently receiving off-label systemic therapy will be eligible to participate in our open-label study, while those who are not receiving such therapy may be recruited into the placebo controlled blinded study. This important feature not only widens the pool of eligible subjects but also eliminates the need for parents or caregivers to make difficult decisions about treatments these patients and loved ones are receiving. The inclusion of this patient population in our studies will be, we believe, a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments.

“Quoin remains fully committed to the Netherton community, their families and treating physicians, and we are proud to be the only company actively dosing Netherton subjects in clinical studies conducted under an open IND. We look forward to continuing our mission to deliver what we hope will be the first safe and effective treatment for this debilitating disease,” concluded Dr. Myers

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