Timber Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for Lead Asset TMB-001

Rhea-AI Summary

Timber Pharmaceuticals has received a formal notice of allowance for its patent application covering isotretinoin composition (U.S. Patent Application No.: 15/772,456) from the USPTO. This patent protection supports the development of TMB-001, a topical isotretinoin therapy for moderate to severe congenital ichthyosis (CI). Timber is working on a clinical program with potential orphan drug exclusivity, backed by a $1.5 million FDA grant for ongoing Phase 2a and 2b trials, actively enrolling patients across 11 sites in the U.S. and Australia.

Positive

• Patent allowance for TMB-001 enhances intellectual property protection.
• Potential orphan drug exclusivity could increase market opportunity.
• Received $1.5 million from FDA to support clinical trials.

Negative

• None.

- Formal notice confirms intent to grant patent for pharmaceutical isotretinoin composition -

WOODCLIFF LAKE, N.J., Dec. 15, 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 rare and orphan dermatologic diseases, today announced that it has received a formal notice of allowance from the U.S. Patent and Trademark Office (USPTO) for the Company’s patent application covering its pharmaceutical isotretinoin composition (U.S. Patent Application No.: 15/772,456).

Timber’s investigational therapy, TMB-001 (topical isotretinoin), is being developed for the treatment of moderate to severe subtypes of congenital ichthyosis (CI), 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. Many dermatologists are familiar with oral isotretinoin, which was originally launched as Accutane®. By formulating isotretinoin into a proprietary topical formulation, it may be possible to reduce systemic absorption, potentially allowing for chronic use over larger areas of the body. 

“We are pleased to announce that our lead product candidate will now have patent protection in addition to potential orphan drug exclusivity pending regulatory approval as we move forward with our clinical development program for this rare dermatologic condition,” said John Koconis, Chief Executive Officer of Timber. “We believe there is an opportunity to deliver a topical composition of isotretinoin that may present many advantages over the oral systemic delivery that is in use today and help patients and families affected by CI in the years ahead.”

In 2018, the FDA awarded $1.5 million to support Phase 2a and Phase 2b clinical trials evaluating TMB-001 through its Orphan Products Clinical Trials Grant program. Timber previously announced that all 11 sites across the U.S. and Australia participating in the Phase 2b CONTROL study evaluating TMB-001 are now initiated and patients with moderate to severe CI are actively enrolling. It is a randomized, double-blind, vehicle-controlled study to investigate the safety and efficacy of two concentrations of TMB-001. 

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 localized 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
adaley@berrypr.com

FAQ

What is the significance of Timber Pharmaceuticals' recent patent allowance for TMB-001?

The patent allowance provides Timber with intellectual property protection for its isotretinoin composition, which is crucial for its clinical development and potential market exclusivity.

How much funding did Timber Pharmaceuticals receive for its clinical trials?

Timber Pharmaceuticals received $1.5 million from the FDA to support its Phase 2a and Phase 2b clinical trials for TMB-001.

What conditions is TMB-001 being developed to treat?

TMB-001 is being developed for the treatment of moderate to severe subtypes of congenital ichthyosis, a rare genetic skin disorder.

What are the current stages of clinical trials for TMB-001?

TMB-001 is currently in the Phase 2b CONTROL study, which has initiated across 11 sites, actively enrolling patients.

Who is the CEO of Timber Pharmaceuticals?

John Koconis serves as the Chief Executive Officer of Timber Pharmaceuticals.