Sol-Gel Technologies (NASDAQ: SLGL), (“Sol-Gel”), today
announced positive topline data for its open-label, long-term
safety study, evaluating Epsolay®, microencapsulated benzoyl
peroxide cream, 5%, in papulopustular rosacea for a treatment
duration up to 52 weeks.
The study enrolled 547 subjects, all of whom had completed 12
weeks of treatment with Epsolay or vehicle in the preceding
double-blind Phase 3 studies. Patients continued onto open-label
treatment with Epsolay once-daily for up to an additional 40 weeks.
The safety population of 535 subjects received Epsolay therapy for
an overall period of at least 28 weeks. Of these 535 subjects, 209
subjects completed 52 weeks of treatment with Epsolay, exceeding
the sample size requirements previously defined by the FDA for the
one-year safety evaluation.
Non-cutaneous adverse events were similar in frequency and type
to those observed in the preceding Phase 3 trials. The most common
adverse event reported was nasopharyngitis (5.4%). Less than 3% of
patients experienced application site adverse events that were
considered to be drug-related, and no serious drug-related adverse
events were reported.
At every study visit, the investigator conducted Local
Tolerability and Cutaneous Safety Assessments. At the end of 52
weeks more than 90% of subjects had “none” or “mild” signs or
symptoms (burning or stinging, itching, dryness and scaling) and no
“severe” tolerability scores were recorded.
Although the study was designed to evaluate long-term safety,
subjects also continued to undergo evaluation according to the
Investigator Global Assessment (IGA) 5-point scale. Of the 209
patients treated with Epsolay for 52 weeks, 73.2% reported a score
of 0 (“clear”) or 1 (“almost clear”) at 52 weeks.
“We are very pleased that these long-term use results further
support and strengthen the positive safety and tolerability data we
previously observed in our Phase 3 program for Epsolay,” said Alon
Seri-Levy, Sol-Gel’s Chief Executive Officer. “It is our hope that
this data can provide patients, seeking long term control of their
chronic condition, the confidence in a treatment that has
demonstrated a favorable safety and tolerability profile. We
believe these results will complete the data required to finalize
our NDA submission, which is planned for the second quarter of this
year.”
About EpsolayEpsolay is an innovative topical
cream containing encapsulated benzoyl peroxide, 5%, that Sol-Gel is
developing for the treatment of inflammatory lesion of rosacea
(Papulopustular Rosacea). Epsolay, if approved, is intended to be
applied to the face once a day. Sol-Gel uses a patented process to
encapsulate benzoyl peroxide in silica-based microcapsules. The
silica shell is aimed to serve as a barrier between the benzoyl
peroxide and the epidermis, reducing the ability of the benzoyl
peroxide to induce strong oxidation processes that may result in
cutaneous adverse events such as erythema, burning and stinging.
The slow migration of benzoyl peroxide from the microcapsules is
aimed to deliver effective doses of benzoyl peroxide onto the skin,
while the barrier improves the tolerability of benzoyl peroxide.
Silica is chemically inert, photochemically and physically stable,
and safe for topical use. If approved, Epsolay has the potential to
be the first FDA-approved single-active benzoyl peroxide
prescription drug product.
About Papulopustular Rosacea Papulopustular
rosacea also known as inflammatory lesion of 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.
About Sol-Gel TechnologiesSol-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 Twyneo, for the
treatment of acne vulgaris, and Epsolay, for the treatment of
papulopustular rosacea. The Company’s pipeline also includes
SGT-210, an early-stage topical epidermal growth factor receptor
inhibitor, erlotinib, for the treatment of
punctate palmoplantar keratoderma, and preclinical assets
tapinarof and roflumilast. For additional information, please
visit www.sol-gel.com.
Forward-Looking StatementsThis 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 clinical
progress of our product candidates and the plans and timing of
submitting an NDA for Epsolay with the FDA. 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 21, 2019 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 to changes in our expectations.
For further information, please contact:Sol-Gel
Contact:Gilad MamlokChief Financial Officer+972-8-9313433
Investor Contact:Chiara Russo Solebury Trout
+1-617-221-9197crusso@soleburytrout.com
Source: Sol-Gel Technologies Ltd.
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