Timber Pharmaceuticals Secures European Orphan Drug Designation

Timber Pharmaceuticals (Nasdaq: TMBR) has received Orphan Drug Designation for TMB-001 for the treatment of X-linked recessive ichthyosis (XLRI) from the European Commission (EC).

This is the company’s second orphan drug designation granted by the EC for TMB-001, which has also received the designation for the treatment of autosomal recessive congenital ichthyosis (ARCI).

Highlights

  • Medicines that are granted orphan drug designation by the EC qualify for financial and regulatory incentives including protocol assistance at reduced fees during product development, access to centralized marketing authorization and 10 years of market exclusivity in the EU after product approval.
  • Timber is assessing the efficacy, pharmacokinetics and safety of TMB-001 (0.05% isotretinoin) in the ongoing pivotal Phase 3 ASCEND clinical trial at leading research centers in the U.S., Canada, Italy, France, and Germany.
  • The study will enroll approximately 142 patients, including children over the age of six, with moderate to severe congenital ichthyosis.

Orphan drug designations underscore the significant unmet medical need in congenital ichthyosis, which can lead to a limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing.

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Timber Pharmaceuticals Secures European Orphan Drug Designation

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