Timber Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for TMB-003 for the Treatment of Systemic Sclerosis
Timber
Expects to Submit Investigational New Drug (IND) Application to the FDA in 2022
WOODCLIFF LAKE, N.J. – 
(NewMediaWire) – January 12, 2021 – Timber Pharmaceuticals, Inc.
(“Timber” or the “Company”) (NYSE American: TMBR), a
biopharmaceutical company focused on the development and commercialization of
treatments for rare and orphan dermatologic diseases, today announced that the
U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TMB-003,
the company’s locally delivered formulation of sitaxsentan, for the treatment
of systemic sclerosis.
“People who are living
with systemic sclerosis or scleroderma often struggle with their quality of
life because the condition can be disfiguring and may cover joints and cause
pain that affects movement and mobility,” said John Koconis, Chief Executive
Officer of Timber. “Currently there is no FDA approved treatment for any
cutaneous symptoms in scleroderma. We are pleased to receive orphan drug
designation for our investigational treatment and look forward to advancing
into clinical stage research.”
The Orphan Drug
Designation program provides orphan status to drugs and biologics that are
intended for the treatment, prevention or diagnosis of a rare disease or
condition that affects less than 200,000 people in the U.S. Systemic sclerosis
is a group of rare autoimmune connective tissue disorders (CTD) characterized by
inflammation and thickening of the skin and other connective tissues from
excessive collagen deposition. Systemic sclerosis leads to abnormalities in the
skin, joints, and internal organs.
Sitaxsentan is a highly
selective endothelin (ET-A) receptor antagonist, which is a class of drugs previously
developed in oral form for the treatment of pulmonary arterial hypertension
(PAH). TMB-003 is a locally delivered formulation of sitaxsentan that has the
potential to reduce collagen while addressing systemic safety concerns associated
with oral administration. Timber is in the preclinical stages of evaluating
TMB-003 for the treatment of scleroderma and expects to submit an
Investigational New Drug (IND) application to the FDA in 2022.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a
biopharmaceutical company focused on the development and commercialization of
treatments for rare and 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 scleroderma. For more information, visit 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, intellectual property rights, 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 Form 10-Q filed on August 18,
2020 and its other 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) 253-8881
