Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug
Application for Epsolay® for the Treatment of Inflammatory Lesions of Rosacea
- PDUFA Goal Date Set for April 26,
- Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product
NESS ZIONA, Israel, September 10, 2020 (GLOBE NEWSWIRE) – Sol-Gel Technologies, Ltd. (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 its New Drug Application (NDA) for Epsolay® (benzoyl peroxide), an investigational proprietary
topical cream for the treatment of inflammatory lesions of rosacea, containing 5% encapsulated benzoyl peroxide, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date
assigned by the FDA for Epsolay is April 26, 2021.
The NDA filing is based on two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated
the safety and efficacy of Epsolay compared to vehicle in patients with papulopustular rosacea (N = 733). In both trials, Epsolay demonstrated a statistically significant improvement in both co-primary endpoints of (i) the number of patients
achieving “Clear” or “Almost Clear” in the Investigator Global Assessment (IGA) scale and (ii) absolute mean reduction from baseline in inflammatory lesion count starting as early as Week 2, and continued through Week 12. Epsolay also demonstrated
a favorable safety and tolerability profile similar to vehicle. The most common adverse reactions occurring in >1% of subjects treated with Epsolay and more frequently than in subjects treated with vehicle was application site erythema (2.3% vs.
0.9%), application site pain (2.3% vs. 0.9%), and application site pruritis (1.2% vs. 0.4%). Most subjects experienced adverse reactions that were mild or moderate in severity.
“Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. Regretfully,
rosacea patients are dissatisfied with the efficacy of current therapies,” stated Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “The results from our Phase 3 studies showed statistically significant higher success in IGA compared with the
vehicle, at every visit, and as early as at Week 2, as well as statistically significant higher reduction in absolute inflammatory lesion counts compared with the vehicle, at every visit, and as early as Week 2. In addition, a quarter of Epsolay
patients in both trials reached their treatment goals within a month, which is very encouraging”.
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 the development of Twyneo® (encapsulated benzoyl peroxide and encapsulated tretinoin) Cream, under investigation for the
treatment of acne vulgaris, and Epsolay, under investigation for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under
investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.
Epsolay is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of
rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules is designed
to deliver an effective dose of benzoyl peroxide to the skin, while reducing the ability of benzoyl peroxide to induce skin irritation, such as erythema, burning and stinging. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. Epsolay is not approved
by the FDA and the safety and efficacy has not been established.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. 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.
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, but not limited to, statements regarding the timing of the PDUFA action
date for Epsolay and the potential to be the first FDA-approved single-agent benzoyl peroxide prescription drug product. These forward-looking statements include information about possible or assumed future results of our business, financial
condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,”
“predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation and are subject to risks and
uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to the
following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our
ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (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) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate
protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution
channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) 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; (xii) 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; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel;
and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 24, 2020 and our other
reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of
this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.
For further information, please contact:
Chief Financial Officer
Lee M. Stern
Source: Sol-Gel Technologies Ltd.