Benzinga | Mar 15, 2021 08:34AM EDT

Timber Pharmaceuticals Announces 50% Enrollment In Phase 2b CONTROL Study In Congenital Ichthyosis

- Study is Evaluating TMB-001 (Topical Isotretinoin) in Subtypes of Rare Genetic Keratinization Disorder

- Company Awarded Final Tranche of $1.5 Million FDA Orphan Products Clinical Trials Grant

WOODCLIFF LAKE, NJ, March 15, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 50 percent of patients in the Phase 2b CONTROL study evaluating TMB-001 (topical isotretinoin) in patients with moderate to severe congenital ichthyosis (CI) have now been randomized. The Company also announced it has been awarded the final tranche of a $1.5 million grant from the U.S. Food & Drug Administration (FDA) Office of Orphan Products Development (OOPD) Orphan Products Clinical Trials Grants Program based on clinical milestones in the development of TMB-001.

"There are many rare dermatologic diseases that do not have any approved therapies and we are committed to advancing research focused on novel topical treatments that may enable targeted delivery to the epidermis and dermis while minimizing systemic absorption," said Alan Mendelsohn, M.D., Chief Medical Officer of Timber. "People living with CI face many significant challenges in everyday life, not just physically but also with psychological well-being and self-esteem. Our success with enrolling the CONTROL study is a testament to the tremendous need for new treatment options. We are grateful to the patients who are participating and organizations like the Foundation for Ichthyosis & Related Skin Types (FIRST) that are helping raise awareness of this study amidst all the difficulties of the COVID-19 pandemic."

CI is a group of rare genetic keratinization disorders that leads 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. 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.

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 study is targeting enrollment of 45 patients aged nine years old and older.

"We hope that by formulating isotretinoin into a proprietary topical we might be able to allow for chronic use on up to 90 percent of body surface area without eliciting the side effect profile of systemic isotretinoin preparations," added Dr. Mendelsohn.

For more information about the Phase 2b CONTROL study, visit https://ichthyosistrial.com/.