Sol-Gel Technologies Initiates Pivotal Phase III Clinical Program for Papulopustular Rosacea
First subject dosed in pivotal Phase III program evaluating Epsolay® in subjects with papulopustularrosacea
Two Phase III trials expected to enroll a total of 700 subjects
Top-line data expected to be reported in 2019
NESS ZIONA,
“The initiation of our pivotal Phase III clinical program for Epsolay is an important milestone in our development program and in introducing our proprietary silica-based microencapsulation delivery system to topical drugs,” said Dr.
The pivotal Phase III clinical program is being conducted in accordance with Special Protocol Assessment (SPA) agreements with the
About Epsolay®
Epsolay® is an innovative topical cream containing encapsulated benzoyl peroxide, 5%, that
About Papulopustular (Subtype II) Rosacea
Rosacea is a chronic and recurrent inflammatory dermatological disorder of unknown etiology. The disease is common, especially in fair-skinned people of Celtic and northern European heritage. The onset of the disorder is usually after age 30. Rosacea typically starts 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, patients experience inflammatory lesions (papules and pustules). According to market research conducted on behalf of the company, approximately 4.8 million people in
About
Forward-Looking Statements
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 statements regarding the expected enrollment in the Epsolay® clinical trials, the expected date to report top-line data for the Phase III clinical program of Epsolay® and the potential clinical uses and therapeutic and other benefits of our product candidates, including Epsolay®. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement, including but not limited to, the following: (i) the fact that we have and expect to continue to incur significant losses; (ii) our need for additional funding, which may not be available; (iii) our ability to complete the development of our product candidates; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) the initiation, timing, progress and results of our clinical trials and other product candidate development efforts; (vi) our ability to rely on data from our Phase II TWIN trial to advance the development of SIRS-T; (vii) our ability to commercialize our product candidates; (viii) our ability to obtain and maintain adequate protection of our intellectual property; (ix) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (x) our ability to establish adequate sales, marketing and distribution channels; (xi) acceptance of our product candidates by healthcare professionals and patients; (xii) the possibility that we may face third-party claims of intellectual property infringement; (xiii) 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; (ixv) 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; (x) potential product liability claims; (xvi) potential adverse federal, state and local government regulation in
For further information, please contact:
Sol-Gel Contact:
Chief Financial Officer
+972-8-9313433
Investor Contact:
Westwicke Partners
+1-415-513-1284
[email protected]
Source: Sol-Gel Technologies Ltd.