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Timber Pharmaceuticals announced significant progress with its lead asset, TMB-001, which has received orphan drug designation from the European Commission for two severe types of congenital ichthyosis (ARCI and XLRI). The company has achieved 50% enrollment in its Phase 3 ASCEND clinical trial, launched in June 2022, following positive FDA interactions earlier in the year. Timber also secured Breakthrough Therapy and Fast Track designations for TMB-001. Financial results showed revenues of $83,177 for 2022, a decrease from $886,532 in 2021, with approximately $9.1 million in cash at year-end. The company is exploring partnerships to fund ongoing operations.
Timber Pharmaceuticals (TMBR) has announced positive results from a sub-analysis of its Phase 2b CONTROL study of TMB-001, a topical isotretinoin for treating congenital ichthyosis (CI).
The study found significant improvements among participants with both autosomal recessive congenital ichthyosis (ARCI) and X-linked recessive ichthyosis (XLRI) in achieving primary and secondary endpoints. In the intent-to-treat population, 33% to 100% of participants with ARCI and XLRI showed a 50% reduction in Visual Index for Ichthyosis Severity (VIIS) compared to vehicle treatments.
Results support continued development of TMB-001, which has orphan designation in Europe, as a promising alternative to systemic therapies.