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– Company plans to ask for end-of-Phase 2
meeting with FDA by end of 2021 –
Basking Ridge, N.J. – 
(“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 it
is completing patient enrollment in the Phase 2b CONTROL study evaluating
TMB-001, a topical pharmaceutical composition of isotretinoin, in patients with
moderate to severe subtypes of congenital ichthyosis (CI) on May 31, 2021 in
order to move forward with Phase 3 trial planning.
“Based on the
positive safety and efficacy data from our unblinded Phase 2a program and
feedback from investigators in our Phase 2b CONTROL study on the results
achieved in many of the 35 enrolled subjects, we feel we are in a strong
position to end enrollment early (trial originally planned for 45 subjects) so
that we can prepare for our pivotal Phase 3 study, starting by requesting end
of Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and global
health authorities in the near future,” said Alan Mendelsohn, M.D., Chief
Medical Officer of Timber. “People living with CI have significant unmet
treatment needs and we are taking this step in a continued effort to advance
the development of TMB-001 as quickly as possible for this rare orphan disease
community.”
CI is a group of
rare genetic keratinization disorders that lead to dry, thickened, and scaling
skin. 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. The management of CI is a life-long endeavor, which
remains largely symptomatic and commonly focused on reducing scaling and/or
skin lubrication with both systemic and topical treatments.
In 2018, the FDA
awarded TMB-001 a $1.5 million grant to support Phase 2a and Phase 2b clinical
trials through its Orphan Products Clinical Trials Grant program. Timber
expects to announce top line results from the Phase 2b CONTROL study in the
fourth quarter of 2021 and is planning for an end-of-Phase 2 meeting with the
FDA by the end of the year.
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 Annual Report on Form 10-K for
the year ended December 31, 2020 as well as other documents that may be filed
by the Company from time to time 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
Chairman and Chief Executive Officer
jkoconis@timberpharma.com
Investor Relations:
Stephanie Prince
PCG Advisory
(646) 863-6341
sprince@pcgadvisory.com
Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881
adaley@berrypr.com
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