Sol-Gel Announces Positive Top-Line Results from Epsolay® Phase 3 Program in Papulopustular Rosacea
- All primary and secondary endpoints achieved in both Phase 3 clinical trials
- Rapid efficacy demonstrated, with statistical significance reached as early as Week 2 compared with vehicle
- Favorable safety and tolerability profile, similar to vehicle
- Conference call and webcast today at
8:30 AM ET
Epsolay is the first in a pipeline of dermatologic product candidates in development using Sol-Gel’s proprietary microencapsulation technology. This platform was designed to enable drug substances to be entrapped in porous silica microcapsules in order to address the limitations of topical drug delivery by stabilizing active drug ingredients, extending drug delivery time and reducing potential irritation caused by direct application to the skin. In the fourth quarter of 2019, top-line Phase 3 results are expected for TWIN, the Company’s investigational fixed-dose combination of microencapsulated benzoyl peroxide and microencapsulated tretinoin being studied for acne vulgaris.
“While we expected to see strong efficacy and tolerability with Epsolay, the rapid efficacy was a standout in our Phase 3 studies,” said Dr.
SGT 54-01 and SGT 54-02 Trial Design
To assess the efficacy and safety of Epsolay in moderate-to-severe papulopustular rosacea, 733 patients aged 18 and older were enrolled in two identical, double-blind, vehicle-controlled Phase 3 clinical trials at 54 sites across the U.S. Patients were randomized at a 2:1 ratio to be treated once-daily with either Epsolay (n=493) or vehicle cream (n=240) for 12 weeks. After the initiation of treatment, clinical and safety evaluations were performed at Weeks 2, 4, 6, 8 and 12. The primary efficacy endpoints for both trials were success in IGA score at Week 12, defined as “clear” (0) or almost clear” (1) on a scale of 0 to 4, and a reduction in absolute mean inflammatory lesion count at week 12.
Baseline Papulopustular Rosacea Severity
In study SGT 54-01, patients in the Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 25.7 and 26.3, respectively. The proportion of patients with “moderate” (3) or “severe” (4) IGA in the Epsolay treatment group was 86.4% and 13.6%, respectively, and 88.1% and 11.9%, respectively, in the vehicle treatment group.
In study SGT 54-02, patients in Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 29.8 and 27.5, respectively. The proportion of patients with “moderate” (3) or “severe” (4) IGA in the Epsolay treatment group was 90.8% and 9.2%, respectively, and 91.8% and 8.2%, respectively, in the vehicle treatment group.
Primary Endpoint Results (intention-to-treat population)
|Proportion of patients achieving “clear” or “almost clear” at Week 12||43.5||%
|Absolute mean change in inflammatory lesion count from baseline at week 12||-17.4||-9.5||<0.001||-20.3||-13.3||<0.001|
Secondary Endpoint Results (intention-to-treat population)
|SGT 54-01||SGT 54-02|
|Proportion of patients achieving “clear” or “almost clear” at Week 4||25.4||%||6.5||%||<0.001||26.1||%||14.1||%||0.009|
|Absolute mean change in inflammatory lesion count from baseline at Week 4||-14.6||-8.7||<0.001||-16.7||-10.5||<0.001|
|Proportion of patients achieving “clear” or “almost clear” at Week 8||39.6||%||15.8||%||<0.001||44.0||%||26.0||%||0.006|
|Absolute mean change in inflammatory lesion count from baseline at Week 8||-16.8||-10.6||<0.001||-20.0||-12.4||<0.001|
Exploratory Endpoint Results (intention-to-treat population)
|SGT 54-01||SGT 54-02|
|Proportion of patients achieving “clear” or “almost clear” at Week 2||9.5||%||3.1||%||0.009||13.2||%||5.5||%||0.017|
|Absolute mean change in inflammatory lesion count from baseline at Week 2||-10.5||-5.5||<0.001||-13.0||-8.0||<0.001|
Safety and Tolerability
Epsolay appeared to be generally safe and well-tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle. Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain reported by less than 3.4% of subjects. There was no treatment-related serious adverse events, with a combined total of 2 unrelated serious adverse events (1 Epsolay, 1 vehicle) reported across both trials. A combined total of 11 subjects (9 Epsolay, 2 vehicle) discontinued treatment due to an adverse event across both trials.
Preliminary Financial Results for the Second Quarter Ended
The Company estimates its revenue for the second quarter of 2019 attributable to sales of its partnered generic product, acyclovir cream, 5%, with
The estimates above represent the most current information available to the Company’s management and do not present all necessary information for an understanding of the Company’s financial condition as of and the results of operations for the quarter ended
|Conference Call and Live Webcast (with slides) @ 8:30 AM Eastern Time
|U.S. toll free:||877-282-0504|
The webcast can be accessed live on the Events & Presentations section of the Company’s website at http://ir.sol-gel.com. It will be archived for 30 days following the call.
Benzoyl peroxide has not been approved by the
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans.1 The condition is common, especially in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
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1 Data on file,
Source: Sol-Gel Technologies Ltd.