Skinvisible Announces Significant Progress in Licensee's Clinical Trials for Invisicare Formulation Targeting Nethertons Syndrome

2024-02-14

临床研究

LAS VEGAS, NV / ACCESSWIRE / February 14, 2024 / Skinvisible, Inc. ("Skinvisible") (OTCQB:SKVI) is excited to share a promising update on the ongoing clinical trials conducted by its licensee, Quoin Pharmaceuticals, Inc. ("Quoin") (NASDAQ:QNRX). The trials focus on the innovative formulation "QRX003," powered by Skinvisible's Invisicare® proprietary drug delivery technology, to address the challenges of Netherton Syndrome ("NS"). Netherton Syndrome is a hereditary disorder affecting the skin, hair and immune system, currently lacking an approved treatment or cure. The preliminary results and updates from Quoin's ongoing clinical studies, operating under an open Investigational New Drug (IND) application, indicate noteworthy progress: Positive Initial Data and Clean Safety Profile: The trials have demonstrated positive initial data and a clean safety profile, leading to the implementation of an optimization plan. Optimization Plan Implementation: Quoin has increased the size of both clinical trials significantly and adjusted dosing frequency to twice-daily from once-daily for both trials. Elimination of Lower Dose: In the blinded trial, a lower dose has been eliminated based on the positive outcomes observed. Protocol Amendments: Quoin's press release highlights protocol amendments aimed at enhancing the data set and potentially expediting regulatory approval. Quoin's CEO, Dr. Michael Myers, expressed enthusiasm about the optimization plan, stating, "Armed with positive initial data and a clean safety pro date, we believe that 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." Terry Howlett, President and CEO of Skinvisible, commented on the encouraging results, emphasizing the potential FDA approval of QRX003 as a significant milestone in providing much-needed relief to Nethertons Syndrome patients, "These developments support Skinvisible's vision to develop effective topical therapeutics and is an important step that could lead to other formulas and indications receiving approval." The Company previously announced that QRX003, the first Invisicare® delivery technology product, has already received acceptance for an Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA). Quoin is actively working towards obtaining necessary FDA and other regulatory approvals for marketing the product in the United States and other countries. About QRX003: QRX003 is a topical lotion formulated with Invisicare®, a proprietary delivery technology, and contains a broad-spectrum serine protease inhibitor serine protease inhibitor. Its mechanism of action mimics the function of the specific protein LEKTI, addressing excessive skin shedding in Netherton patients and strengthening the compromised skin barrier. Skinvisible is dedicated to advancing topical therapeutics, and the progress in QRX003's clinical trials aligns with the company's commitment to delivering effective treatments for underserved patient populations. 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: . About Skinvisible Pharmaceuticals, Inc. Skinvisible Pharmaceuticals is a research and development company that licenses its proprietary formulations made with Invisicare®, its patented polymer delivery system that offers life-cycle management and unique enhancements for topical and transdermal delivered products. Invisicare holds active ingredients on the skin for extended periods of time, allowing for the controlled release of actives. As well, and if required, the Invisicare technology allows for a controlled transdermal release through the skin. For more information please visit . Forward-Looking Statements: This press release contains 'forward looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby including with respect to the possible development of any such products, the acceptance of any such products in the market place, the size of any such markets, the ability of any product candidates to be approved by the U.S. Food and Drug Administration among others. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward-looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the period ending September 31, 2023). ### Contact: Doreen McMorran info@skinvisible.com PH: 702-433-7154 x 7 SOURCE: Skinvisible, Inc. View the original press release on accesswire.com