Timber Reports Completion of End-of-P-II Meeting with the US FDA for to Treat Congenital Ichthyosis
Shots:
- The company reports completion of P-IIb (CONTROL) study to evaluate the efficacy & safety of TMB-001 (0.05%/0.1%) vs vehicle in a ratio (1:1:1) in 33 patients with CI for 12wks.
- The primary efficacy EPs was the proportion of patients with VIIS-scaling treatment with a 50% reduction in the VIIS score over baseline. For the PP & ITT population, patients achieved VIIS-50 (100%/40% vs 40%) & (64%/40% vs 33%) along with 50% of the patients showed relief in ≤28 days
- For the PP & ITT population in the 2EPs i.e., patients reported a ≥2-grade IGA score improvement (100%/60% vs 10%) & (55%/40% vs 8%), no serious AEs were identified. The company is planning to initiate a P-III study in Q2’22
Ref: Globe Newswire | Image: PR Newswire
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