Timber Pharmaceuticals Announces All CONTROL Study Sites Open and Enrolling Patients with Moderate to Severe Congenital Ichth...
July 01 2020 - 08:00AM
via NEWMEDIAWIRE -- Timber Pharmaceuticals, Inc. ("Timber" or the
“Company”) (NYSE American: TMBR), a biopharmaceutical company
focused on the development and commercialization of treatments for
orphan dermatologic diseases, today announced that all 11 sites
across the U.S. and Australia participating in the Phase 2b CONTROL
study evaluating TMB-001 (topical isotretinoin) are now initiated
and patients with moderate to severe congenital ichthyosis (CI) are
actively enrolling. The company also announced that 70 percent of
sites participating in a Phase 2b clinical trial evaluating TMB-002
(topical rapamycin) for the treatment of facial angiofibromas (FAs)
in tuberous sclerosis complex (TSC) are now open and enrolling
patients.
“Our team has been working tirelessly with clinical trial
investigators and researchers amid the COVID-19 pandemic to ensure
we could open as many trial sites as possible, quickly and safely,
and allow enrollment of patients who are eligible and eager to
participate,” said John Koconis, chief executive officer of Timber.
“The collective efforts of our team made these significant
milestones possible during an extremely challenging time. We look
forward to continuing patient enrollment as we rapidly advance our
promising clinical development programs for those with limited
treatment options.”
CI is a group of rare genetic keratinization disorders that
leads to dry, thickened, and scaling skin. The Phase 2b CONTROL
study is a randomized, parallel, double-blind, vehicle-controlled
study to assess the efficacy and safety of two concentrations of
TMB-001 for the treatment of moderate to severe subtypes of CI. The
Phase 2b CONTROL study is targeting enrollment of 45 patients aged
nine years old and older. People living with CI may have limited
range of motion, chronic itching, an inability to sweat normally,
high risk of secondary infections, and impaired eyesight or
hearing. Moderate to severe subtypes of CI, including X-linked
ichthyosis and lamellar ichthyosis, affect about 80,000 people in
the U.S. and more than 1.5 million globally. In 2018, the U.S. Food
& Drug Administration (FDA) awarded an Orphan Products Grant to
support Phase 2a and Phase 2b clinical trials evaluating
TMB-001.
The Phase 2b clinical trial evaluating TMB-002 for the treatment
of FAs in TSC is targeting enrollment of 120 patients across 16
sites globally. TSC is a multisystem genetic disorder resulting in
the growth of hamartomas in multiple organs. There are about 40,000
people living with FAs from TSC in the U.S., and about 800,000
globally.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the development and commercialization of treatments for
orphan dermatologic diseases. The Company's investigational
therapies have proven mechanisms-of-action backed by decades of
clinical experience and well-established CMC (chemistry,
manufacturing and control) and safety profiles. The Company is
initially focused on developing non-systemic treatments for rare
dermatologic diseases including congenital ichthyosis (CI), facial
angiofibromas (FAs) in tuberous sclerosis complex (TSC), and
localized scleroderma. For more information,
visit https://www.timberpharma.com/.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private
Securities Litigation Reform Act, as amended, including those
relating to the Company's product development, clinical and
regulatory timelines, market opportunity, competitive position,
possible or assumed future results of operations, business
strategies, potential growth opportunities and other statements
that are predictive in nature. These forward-looking statements are
based on current expectations, estimates, forecasts and projections
about the industry and markets in which we operate and management's
current beliefs and assumptions.
These statements may be identified by the use of forward-looking
expressions, including, but not limited to, "expect," "anticipate,"
"intend," "plan," "believe," "estimate," "potential, "predict,"
"project," "should," "would" and similar expressions and the
negatives of those terms. These statements relate to future events
or our financial performance and involve known and unknown risks,
uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such factors include those set
forth in the Company's filings with the Securities and Exchange
Commission. Prospective investors are cautioned not to place undue
reliance on such forward-looking statements, which speak only as of
the date of this press release. The Company undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
For more information, contact:
Timber Pharmaceuticals, Inc. John Koconis Chief
Executive Officer jkoconis@timberpharma.com
Investor Relations: Stephanie Prince PCG Advisory (646) 762-4518
sprince@pcgadvisory.com
Media Relations: Adam Daley Berry & Company Public Relations
(212) 253-8881adaley@berrypr.com
Timber Pharmaceuticals (AMEX:TMBR)
Historical Stock Chart
From Feb 2024 to Mar 2024
Timber Pharmaceuticals (AMEX:TMBR)
Historical Stock Chart
From Mar 2023 to Mar 2024