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 Twyneo® (benzoyl peroxide and tretinoin), an
investigational proprietary fixed-dose combination of 3%
encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin cream
for the treatment of acne vulgaris, 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 Twyneo is
August 1, 2021.
The NDA filing is based on two positive pivotal Phase 3
randomized, double-blind, multicenter, 12-week, clinical trials
that evaluated the safety and efficacy of Twyneo compared to
vehicle in patients 9 years of age and older with
moderate-to-severe acne vulgaris (N = 858). In both trials, Twyneo
demonstrated statistically significant improvement in all
co-primary endpoints in the treatment of patients with acne
vulgaris of (i) the proportion of patients who succeeded in
achieving at least a two grade reduction from baseline and Clear
(grade 0) or Almost Clear (grade 1) at Week 12 on a 5-point
Investigator Global Assessment (IGA) scale, (ii) an absolute change
from baseline in inflammatory lesion count at Week 12 and (iii) an
absolute change from baseline in non-inflammatory lesion count at
Week 12. The most common adverse events were local reactions, such
as pain, dryness, exfoliation, erythema, dermatitis, pruritus and
irritation, with nearly all adverse events (AEs) being mild or
moderate in severity and no treatment-related serious AEs.
Acne vulgaris is a multifactorial disease that is often treated
with a combination of drugs. Twyneo combines two active ingredients
that have a complementary mechanism of action in a compelling
once-daily treatment.
“This is another important milestone achieved on time by
Sol-Gel, in addition to the previous acceptance for filing by the
FDA of Epsolay in papulopustular rosacea,” commented Dr. Alon
Seri-Levy, Chief Executive Officer of Sol-Gel. “We are proud that
by using our proprietary microencapsulation technology we have
managed to overcome the instability of tretinoin when combined with
benzoyl peroxide. If approved, Twyneo has the potential to provide
relief for many of the approximately 40-50 million people in the
United States who suffer from acne vulgaris.”
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 (benzoyl peroxide and 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 Twyneo
Twyneo is an investigational, antibiotic-free, fixed-dose
combination of encapsulated benzoyl peroxide, 3%, and encapsulated
tretinoin, 0.1%, cream for the treatment of acne vulgaris. If
approved, it will be the first acne treatment that contains a
fixed-dose combination of benzoyl peroxide and tretinoin, which are
separately encapsulated in silica using Sol-Gel’s proprietary
microencapsulation technology. Tretinoin and benzoyl peroxide are
widely prescribed separately as a combination treatment for acne;
however, benzoyl peroxide causes degradation of the tretinoin
molecule, thereby potentially reducing its effectiveness if used at
the same time or combined in the same formulation. The silica-based
microcapsule is designed to protect tretinoin from oxidative
decomposition by benzoyl peroxide, thereby enhancing the stability
of the active drug ingredients. The silica-based shell is also
designed to release the ingredients slowly over time to provide a
favorable efficacy and safety profile. Twyneo is not approved by
the FDA and the safety and efficacy has not been established.
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that
according to the American Academy of Dermatology affects
approximately 40 to 50 million people in the United States. The
disease occurs most frequently during childhood and adolescence
(affecting 80% to 85% of all adolescents) but it may also appear in
adults. Acne patients suffer from the appearance of lesions on
areas of the body with a large concentration of oil glands, such as
the face, chest, neck and back. These lesions can be inflamed
(papules, pustules, nodules) or non-inflamed (comedones). Acne can
have a profound effect on the quality of life of those suffering
from the disease. In addition to carrying a substantial risk of
permanent facial scarring, the appearance of lesions may cause
psychological strain, social withdrawal and lowered
self-esteem.
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 Twyneo
and the potential to be the first acne treatment that contains a
fixed-dose combination of benzoyl peroxide and tretinoin. 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:Michael LevitanSolebury Trout
+1-646-378-2920mlevitan@soleburytrout.com
Source: Sol-Gel Technologies Ltd.
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