Sol-Gel Completes Successful Phase II Study in Rosacea
- Category: Small Molecules
- Published on Wednesday, 05 December 2012 13:41
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NESS ZIONA, Israel I December 5, 2012 I Sol-Gel Technologies Ltd. announced today positive results for a Phase II trial in the U.S. targeting mild-to-severe rosacea using a benzoyl peroxide drug product developed by Sol-Gel. Although benzoyl peroxide is an established treatment for acne, until now it has not been used for the treatment of rosacea because it causes a high degree of skin irritation. Sol-Gel's proprietary silica-based microencapsulation drug delivery system, successfully demonstrated in the study that it can ultimately provide a safe and effective first-in-class treatment.
"The study results, could change the way physicians treat rosacea," said Dr. Alon Seri-Levy, Sol-Gel’s co-founder and CEO. Noting that encapsulated benzoyl peroxide (E-BPO) is the first drug in Sol-Gel's pipeline of innovative topical dermatological drugs to complete Phase II studies, he added: "We plan to initiate Phase III studies for E-BPO next year".
The double-blind, randomized, vehicle-controlled, dose-range study was carried out at eight medical centers in the U.S. on 92 rosacea patients. The patients received one of two doses of E-BPO or a vehicle gel (control group). The length of the treatment was 12 weeks. The two tested doses were 1% and 5% E-BPO.
The primary objective of the study was to identify the lowest dose of E-BPO gel that demonstrates both safety and effectiveness in the treatment of rosacea.
There were two primary efficacy endpoints: the proportion of subjects with the primary measure of success, defined as a 2-grade improvement in the Investigator Global Assessment (IGA) relative to Baseline at Week 12, with patients at Week 12 IGA being clear or almost clear of symptoms; and the change in inflammatory lesion count at Week 12.
In the current study, 53 percent of the patients treated with doses of 5% E-BPO achieved the primary success criteria compared to 20 percent of the vehicle control group.
Reduction in mean inflammatory lesion count was 69 percent for the 5% E-BPO group compared to 33 percent in the vehicle control group.
5% E-BPO gel showed a favorable safety profile and was well tolerated.
Rosacea, a chronic and recurrent inflammatory dermatological disorder of unknown etiology, is common, especially in fair-skinned people of Celtic and northern European heritage. Rosacea affects about 16 million Americans; of these patients, only about 10 percent are treated. Rosacea, often misdiagnosed as acne vulgaris, usually starts as flushing and subtle redness on the cheeks, nose, chin, or forehead, and if left untreated, can slowly worsen over time. As the condition progresses, subjects experience inflammatory lesions (papules and pustules), vivid erythema, and telangiectasia. The onset of the disorder is usually between the ages of 30 years and 50 years. Alcohol, hot drinks, spicy foods, stress, sunlight, and extreme heat or cold can trigger the onset of this disease.
About Sol-Gel Technologies
Sol-Gel Technologies is a specialty pharmaceuticals company that develops innovative topical products for the dermatology market. Sol-Gel's patented delivery systems are designed to enhance the efficacy, safety and stability of topical drugs.
With topical drugs, there is often a trade-off between high efficacy on the one hand, and uncompromised tolerability on the other. Sol-Gel’s patented drug delivery systems provide an optimal solution by encapsulating active ingredients in an inert, silica shell. Sol-Gel’s microcapsules create an unnoticeable barrier between the active ingredient and the skin. The active ingredient migrates through the pores of the microcapsules, delivering effective doses into the skin, while the barrier improves tolerability of the active ingredient.
The Company was founded in 1997 to commercialize a breakthrough technology developed by co-founder Professor David Avnir of the Hebrew University of Jerusalem.