NESS ZIONA, Israel, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Sol-Gel Technologies Ltd. (“Sol-Gel”) (NASDAQ:SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that data will be presented from the company’s Phase 2 clinical trial for TWIN in the treatment of acne and also from its Phase 2 clinical trial for VERED in the treatment of subtype II rosacea at the 2018 American Academy of Dermatology (AAD) Annual Meeting taking place February 16-20 in San Diego, California.
The TWIN Phase 2 trial was a six-arm, randomized, double-blind, placebo-controlled clinical trial that enrolled 726 subjects at 36 sites in the United States. The trial evaluated the efficacy, tolerability and safety of two TWIN concentrations, TWIN High and TWIN Low, containing a higher or lower concentration of encapsulated tretinoin and an identical concentration of encapsulated benzoyl peroxide. Each of tretinoin and benzoyl peroxide, the two active components in TWIN, are widely used single agent therapies for acne that historically have not been conveniently co-administered. The trial also evaluated the separate active components of TWIN; both the higher and lower concentrations of encapsulated tretinoin and encapsulated benzoyl peroxide administered as a single agent. In this trial, TWIN showed statistically significant improvements in all pre-defined co-primary and secondary efficacy endpoints, as compared to vehicle. TWIN also exhibited favorable efficacy results compared to its active components. TWIN demonstrated excellent cutaneous tolerability with no treatment-related serious adverse events.
The VERED Phase 2 was a multi-center, three-arm, randomized, double-blind, placebo-controlled study designed to assess the efficacy, tolerability and safety of two VERED concentrations, VERED 1% (encapsulated benzoyl peroxide 1%) and VERED 5% (encapsulated benzoyl peroxide 5%). A total of 92 subjects were enrolled in the trial at ten sites in the United States. Subjects were equally randomized into three separate arms: VERED 1%, VERED 5% and vehicle and each group received a once-daily dose. VERED showed statistically significant improvements in the IGA pre-defined co-primary efficacy endpoint and in the percent change in inflammatory lesion count at week 12, as compared to vehicle. VERED was also well tolerated in the trial.
The scheduled time and location of the data presentations are as follows:
TWIN Phase 2 Efficacy Trial
Oral Presentation 1: Acne and Rosacea session
Location: Room 1A
Time: Saturday, February 17, 9:20 a.m. PST
Presentation Title: Cutting Edge Acne Treatments
Presenting Author: Dr. Hilary Baldwin
Oral Presentation 2: Hot Topics
Location: Room 6D
Time: Monday, February 19, 9:30 a.m. PST
Presentation Title: Acne: What’s New?
Presenting Author: Dr. Hilary Baldwin
VERED Phase 2 Efficacy Trial
Oral Presentation: Acne and Rosacea session
Location: Room 1A
Time: Saturday, February 17, 10:35 a.m. PST
Presentation Title: Treating Rosacea: What have we learned?
Presenting Author: Dr. Linda Stein-Gold
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.
About Rosacea
Rosacea is a chronic skin disease characterized by facial redness, inflammatory lesions, burning and stinging. According to the U.S. National Rosacea Society, approximately 16 million people in the United States are affected by rosacea. According to a study we commissioned, approximately 4.8 million people in the United States experience subtype II symptoms. Subtype II rosacea is characterized by small, dome-shaped erythematous papules, tiny surmounting pustules on the central aspects of the face, solid facial erythema and edema, and thickening/overgrowth of skin. Subtype II rosacea resembles acne, except that comedones are absent, and patients may report associated burning and stinging sensations.
About Sol-Gel Technologies
We are a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Our current product candidate pipeline consists of late-stage branded product candidates that leverage our proprietary, silica-based microencapsulation technology platform, and several generic product candidates across multiple indications.
For further information, please contact:
Sol-Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972-8-9313433
Investor Contact:
Patricia L. Bank
Westwicke Partners
+1-415-513-1284
[email protected]
Source: Sol-Gel Technologies Ltd.
