NESS ZIONA, Israel, Jan. 02, 2020 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (SLGL) today announced the initiation of a Phase 1 proof of concept clinical study of SGT-210, its novel, topical, epidermal growth factor receptor inhibitor in patients with punctate palmoplantar keratoderma type -1 (PPPK type 1), a genetic form of PPK.  Top-line data is expected in the first half of 2021.

“Patients with PPK suffer from the physical manifestations of the disease and the thickened skin can interfere with daily activities,” said Dr. Eli Sprecher MD, Ph.D., Chairman of the Division of Dermatology at the Tel Aviv Sourasky Medical Center.  “I am delighted that The Tel Aviv Medical Center is running a clinical trial aimed at assessing the clinical efficacy of Sol-Gel’s novel product.”

The Phase 1 proof of concept study SGT-84-01 is a single-center, single-blinded, vehicle-controlled study designed to evaluate the bioavailability, safety and tolerability of SGT-210 as well as inform on potential efficacy. The study is targeting enrollment of approximately 15 patients to undergo a three month treatment period, followed by a three month follow-up period.

“Initiation of this study is another important step forward with our SGT-210 development program into PPK and to expand our proprietary pipeline,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Existing approaches, often result in disappointing efficacy and poor tolerability, SGT-210 may represent a significant advancement for patients suffering with PPK disorders. We look forward to the upcoming top-line results from this trial, which are expected the first half of 2021.”

About Palmoplantar Keratoderma
Palmoplantar keratoderma (PPK) is a group of skin conditions characterized by the thickening of the skin on the palms and soles of the feet. PPK may lead to impairment of quality of life through pain, decreased acral functionality and cosmetic concerns. Traditional therapeutic approaches for PPK are mainly based on decreasing scale, controlling hyperkeratosis and blunting inflammation when present. Existing remedies may further impair the epidermal barrier and lead to compensatory exaggerated epidermal proliferation. Therefore, safe and effective management of PPK represents an important unmet medical need.

About SGT-210
SGT-210 is a topically administered, epidermal growth factor receptor (EGFR) inhibitor.  EGFR is a growth factor receptor that induces cell differentiation and proliferation upon activation through the binding of one of its ligands. It is believed that SGT-210 will work to inhibit this action and thus address the excessive skin growth and thickening which results in the significant impairment associated with PPK disorders.  Prevalence estimates of PPK suggest approximately 90,000 people in the US alone may have some variant of the disease.  Should SGT-210 succeed, it may represent a US market potential of approximately $500 million with additional potential outside the US.

About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for both branded and generic product development.  SolGel’s current late-stage branded pipeline includes Twyneo®, for the treatment of acne vulgaris, Epsolay®, for the treatment of papulopustular rosacea, and SGT-210, an early-stage topical epidermal growth factor receptor inhibitor for the treatment of punctate palmoplantar keratoderma type I. For additional information, please visit www.sol-gel.com.