- Event to be held on December 6, 2023 will focus on preventing basal cell carcinomas associated with Gorlin syndrome with a discussion of the disease burden, SGT-610 and the upcoming Phase 3 trial
NESS ZIONA, Israel, Nov. 28, 2023 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (Nasdaq: SLGL) (“Sol-Gel”), a dermatology company leveraging innovative approaches to develop pioneering treatments for patients with severe skin conditions, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced it will host a virtual KOL event on Wednesday, December 6, 2023 at 12:00 PM ET. To register, click here.
The event will feature Julie Breneiser (Executive Director, Gorlin Syndrome Alliance) and Ervin Epstein Jr., MD (Co-Founder of PellePharm Inc.), who will discuss the significant disease burden of Gorlin syndrome patients and lack of effective therapies. Gorlin syndrome is a rare genetic disorder associated with growth of multiple basal cell carcinomas.
The event will also focus on the therapeutic potential of SGT-610 (patidegib gel), a new hedgehog inhibitor (HHI), in development to prevent new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome with the potential for a more favorable tolerability profile compared to approved oral HHIs. SGT-610 has been granted Orphan Drug Designation as well as Breakthrough Designation by the FDA.
Alon Seri-Levy, PhD (Co-Founder and Chief Executive Officer, Sol-Gel Therapeutics) will provide an overview of the upcoming SGT-610 Phase 3 study, including strategies intended to optimize success of the study, and insights on market potential. A live question and answer session will follow the formal presentation.
About Julie Breneiser
Julie Breneiser is the Executive Director of the Gorlin Syndrome Alliance (GSA). Prior to her position as director, Julie served as volunteer Board President for the GSA. Mrs. Breneiser and her two young adult children are affected with Gorlin syndrome, a rare genetic disorder caused by a tumor suppressant mutation that can affect every organ system. Her early career began as a Physician Assistant followed by teaching preschoolers with disabilities. Mrs. Breneiser’s work with the GSA focuses on collaboration with industry to bring new and/or potential treatments to clinical trial. She also provides individual support to affected patients and their caregivers along with educating health care providers about this rare disease. Mrs. Breneiser previously served as a consumer reviewer for the National Institutes of Health and the Department of Defense’s Congressionally Directed Medical Research Program. Mrs. Breneiser speaks nationally and internationally raising awareness about Gorlin syndrome.
About Ervin Epstein, Jr., MD
Dr. Ervin Epstein, Jr., MD is a leading dermatologist in Oakland, California. He received his medical degree from University of California (San Francisco) School of Medicine and was in practice for more than 50 years. He served as the Co-Founder, Medical Advisor, and Director at PellePharm, Inc. He also served as Research Dermatologist and Clinical Professor of Dermatology at the University of California, San Francisco. His research interests have focused on the molecular biology of inherited and neoplastic skin diseases. has served as President of the Society for Investigative Dermatology. Ervin Epstein has also served on the boards of numerous dermatological organizations including The American Dermatological Association. His publications have appeared in New England Journal of Medicine, Nature, and Science.
About Alon Seri-Levy, PhD
Alon Seri-Levy, PhD co-founded Sol-Gel and has served as chief executive officer since the Company’s inception in 1997 and as a member of the board of directors until 2014. Prior to founding Sol-Gel, Dr. Seri-Levy established the computer-aided drug design department at Peptor Ltd., an Israeli research and development company that specialized in the development of peptide-based drug products. Dr. Seri-Levy holds a PhD in Chemistry (summa cum laude) from The Hebrew University of Jerusalem, Israel, and conducted his post-doctoral studies at Oxford University, United Kingdom. Dr. Seri-Levy was reappointed to our board of directors in January 2018, immediately following the pricing of the company’s initial public offering.
About Gorlin Syndrome and SGT-610
SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for Gorlin syndrome, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow basal cell carcinoma (BCC) tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to and commercialized by Galderma in the U.S.
The Company’s pipeline includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas.
For additional information, please visit www.sol-gel.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, the timing of beginning the Phase 3 clinical trial of SGT-610, success of any clinical studies, and obtaining regulatory approval for our product candidates including SGT-610;the favorable tolerability profile of SGT-610, and the market potential of SGT-610 . In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, a delay in the timing of our clinical trials, including the timing of beginning the Phase 3 clinical trial of SGT-610, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors, and other important factors discussed in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 10, 2023, as amended, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.
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