NEW YORK, NY, December 13, 2023 – Quoin Pharmaceuticals (Nasdaq: QNRX) has received U.S. Food and Drug Administration (FDA) clearance to implement several protocol amendments to its two ongoing clinical trials for QRX003, which is a potential treatment for Netherton Syndrome, a rare genetic skin disease for which there is no cure and no approved treatments. These protocol amendments are being implemented with a view to generating an even more robust data set and potentially more rapid regulatory approval with a broader label.
The company’s two ongoing trials are being conducted under Quoin’s open Investigational New Drug Application (IND) for QRX003. Following the release of positive safety data, the lower dose of QRX003 was removed, and twice-daily dosing will be used going forward in both trials. In both studies to date, QRX003 has demonstrated an “exemplary safety profile”.
The number of subjects in the blinded clinical trial will increase from 18 to 30 and from 10 to 20 in the open-label trial. Quoin will add more sites to serve newly enrolled subjects as interest from clinical investigators and patients remains at a very high level. Current clinical endpoints for both trials remain unchanged.
Following the announcement, Quoin Pharmaceuticals CEO Dr. Michael Myers stated, “We are extremely pleased to announce clearance of our clinical trial optimization plan for QRX003 in NS. Armed with positive initial data and a clean safety profile to date, we believe these protocol amendments could ultimately result in the generation of a highly compelling data set which could support regulatory filings and approval for QRX003 as the first treatment for this terrible disease. These latest developments underscore Quoin’s continued commitment to delivering a safe and effective treatment for this very underserved patient population.”
Last month, Quoin announced its ninth commercial partnership for QRX0003 in Singapore, expanding its total partnerships to 61 countries across the globe. The company’s ultimate goal is to make the treatment available to patients in as many countries as possible following approval. In addition, the contract manufacturer for QRX003’s active ingredient successfully developed and scaled up a new and fully good manufacturing practice (GMP) for the substance with the source being exclusively available to Quoin.
In a recent update, Quoin the company reported cash, cash equivalents and marketable securities of approximately $14 million as of Sept. 30, providing a cash runway expected to extend through 4Q 2024.
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PRISM MarketView Biotech in Motion Spotlight: @QuoinPharma (Nasdaq: $QNRX) Receives @US_FDA Clearance for Netherton Syndrome Clinical Optimization Planhttps://t.co/Vd8oh3rTqJ#stockstowatch #StocksInFocus #investors#PrismMarketView #PrismMediaWire #PrismDigitalMedia…
— PrismMarketView (@PrismMarketView) December 13, 2023