Timber Pharmaceuticals Announces All CONTROL Study Sites Open & Enrolling Patients With Moderate-to-Severe Congenital Ichthyosis

Timber Pharmaceuticals, Inc. recently announced that all 11 sites across the US 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% 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 US and more than 1.5 million globally. In 2018, the US 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 US, and about 800,000 globally.

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/.