Timber Pharmaceuticals Announces Publication of Sub-Analysis of Phase 2b CONTROL study in Clinical and Experimental Dermatology

- Treatment with TMB-001 demonstrated greater proportions of participants achieving primary and key secondary endpoints versus vehicle regardless of the subtype of congenital ichthyosis -

BASKING RIDGE, NJ, March 20, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced the online publication of a sub-analysis of the Phase 2b CONTROL study in Clinical and Experimental Dermatology (CED), the educational journal of the British Association of Dermatologists. The CONTROL study evaluated TMB-001, a topical isotretinoin formulated using the Company’s patented IPEG delivery system, in subjects nine years of age and older with moderate to severe congenital ichthyosis (CI).

CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. CI subtypes display variable responses to oral retinoids. The sub-analysis was designed to assess whether the efficacy and safety of TMB-001 differed between subjects with autosomal recessive congenital ichthyosis (ARCI) and X-linked recessive ichthyosis (XLRI). Results show that treatment with TMB-001 demonstrated greater proportions of participants achieving the primary and key secondary endpoints versus vehicle regardless of the subtype of CI.

“Patients with severe CI must often combine bathing, mechanical scale removal, and topical over-the-counter emollient therapy with the possible addition of systemic retinoid therapy throughout their lifetimes to address their disease, sometimes without significant improvement,” said Christopher Bunick, M.D., Ph.D., Associate Professor of Dermatology at Yale University School of Medicine and corresponding author of the paper. “In this sub-analysis, participants in the CONTROL study with ARCI and XLRI mostly showed comparable percentage differences in responses to treatment with a novel topical isotretinoin formulation versus vehicle. That is especially encouraging because systemic retinoids do not typically demonstrate the same efficacy across subtypes of CI.”