Timber Pharmaceuticals’ TMB-001 Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Congenital Ichthyosis

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The US FDA has granted BTD to TMB-001 for the treatment of CI. The preliminary study showed a substantial improvement over available therapy on a clinically significant EPs
The results from the P-IIb (CONTROL) study of TMB-001 showed a clinical reduction in targeted & overall severity of CI along with a favorable safety profile. The P-IIb (CONTROL) study’s sub-analysis revealed that patients treated with TMB-001 had treatment success regardless of the type of CI
The company has initiated the P-III (ASCEND) trial to evaluate the efficacy & safety of TMB-001 for CI at research centers in the US, Canada, Italy, France & Germany with an expected first patient dosing in June 2022

Ref: Timber Pharmaceuticals | Image: Timber Pharmaceuticals