Benzinga | Dec 15, 2020 08:00AM EST

Timber Pharma Reports Notice Of Allowance From US Patent & Trademark Office For Lead Asset TMB-001

Timber Pharmaceuticals, Inc. ("Timber" or the "Company") (NYSE: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(r). 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.