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.
About Epsolay®
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.
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, 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:
Sol-Gel Contact:Gilad MamlokChief Financial
Officer+972-8-9313433
Investor Contact:Lee M. SternSolebury
Trout+1-646-378-2922lstern@soleburytrout.com
Source: Sol-Gel Technologies Ltd.
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