Timber Pharmaceuticals Announces All CONTROL Study Sites Open and Enrolling Patients with Moderate to Severe Congenital Ichthyosis

- Phase 2b CONTROL study is evaluating TMB-001 (topical isotretinoin) in subtypes of rare genetic keratinization disorder -

- Company also advancing Phase 2b clinical trial evaluating TMB-002 (topical rapamycin) for treatment of facial angiofibromas in tuberous sclerosis complex with 70% of trial sites now open -

WOODCLIFF LAKE, N.J., July 01, 2020 (GLOBE NEWSWIRE) -- 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

Investor Relations:
Stephanie Prince
PCG Advisory
(646) 762-4518

Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881

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