Timber announces publication of sub-analysis of Phase 2b CONTROL study

Timber Pharmaceuticals 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. A total of 33 participants in the CONTROL study were randomized to TMB-001 0.05%, TMB-001 0.1%, or vehicle twice daily, stratified by CI subtype, for 12 weeks. The primary endpoint was the proportion of participants with a 50% or greater reduction versus baseline in Visual Index for Ichthyosis Severity (VIIS) scaling. The key secondary endpoint was a two-grade or greater reduction in Investigator Global Assessment scaling score versus baseline. Adverse events were monitored. In the ITT population, 33%/50%/17% of participants with ARCI and 100%/33%/75% of participants with XLRI who received TMB-001 0.05%/TMB-001 0.1%/vehicle, respectively, achieved VIIS-50. In the per-protocol, PP, population, 100%/33%/17% of participants with recessive congenital ichthyosis, ARCI, and 100%/50%/75% of participants with X-linked recessive ichthyosis, XLRI, who received TMB-001 0.05%/TMB-001 0.1%/vehicle, respectively, achieved VIIS-50. In the intent-to-treat population, improvement of greater than or equal to2-grade IGA score was observed in 33%/50%/0% of participants with ARCI and 83%/33%/25% of participants with XLRI who received TMB-001 0.05%/TMB-001 0.1%/vehicle, respectively. In the PP population, improvement of greater than or equal to2-grade IGA score was observed in 100%/67%/0% of participants with ARCI and 100%/50%/25% of participants with XLRI who received TMB-001 0.05%/TMB-001 0.1%/vehicle, respectively. Most AEs reported were application site reactions and were similarly distributed among both subgroups.