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NEWS
Quoin Pharmaceuticals Announces FDA Clearance to Initiate New QRX003 Netherton Syndrome Clinical Study
Thursday, 19th December at 8:00 am
• Groundbreaking ‘Whole Body' Study will be conducted by Dr. Amy Paller at Northwestern University
• Up to eight subjects will have QRX003 applied twice daily to greater than 80% of their body surface area over a 12-week period
• Study intended to generate data based on product use resembling potential real-world use
• Third Netherton Syndrome clinical study to be conducted under Quoin's open Investigational New Drug application
ASHBURN, Va., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003. QRX003 is a topical lotion that contains a broad-spectrum serine protease inhibitor designed to target the kallikreins in the skin responsible for the excessive skin shedding associated with this disease.
The study will be conducted by Dr. Amy Paller, of Northwestern University. It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period. By comparison, in Quoin's ongoing open-label and double-blinded clinical studies, QRX003 is applied to approximately 20% of the subject's BSA, typically the arms and lower leg. This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date. It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS.
Thursday, 19th December at 8:00 am
• Groundbreaking ‘Whole Body' Study will be conducted by Dr. Amy Paller at Northwestern University
• Up to eight subjects will have QRX003 applied twice daily to greater than 80% of their body surface area over a 12-week period
• Study intended to generate data based on product use resembling potential real-world use
• Third Netherton Syndrome clinical study to be conducted under Quoin's open Investigational New Drug application
ASHBURN, Va., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003. QRX003 is a topical lotion that contains a broad-spectrum serine protease inhibitor designed to target the kallikreins in the skin responsible for the excessive skin shedding associated with this disease.
The study will be conducted by Dr. Amy Paller, of Northwestern University. It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period. By comparison, in Quoin's ongoing open-label and double-blinded clinical studies, QRX003 is applied to approximately 20% of the subject's BSA, typically the arms and lower leg. This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date. It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS.
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