New TMB-001 subanalytical data published in Clinical and Experimental Dermatology

Sub Levels


Data from a sub-analysis of Timber Pharmaceuticals’ Phase 2b CONTROL trial evaluating the safety and efficacy of TMB-001 for the treatment of congenital ichthyosis (CI) were recently published online. Clinical and experimental dermatology.1 In a 12-week analysis, topical isotretinoin, TMB-001, reduced signs and symptoms of autosomal recessive congenital ichthyosis (ARCI) and X-linked recessive ichthyosis (XLRI) and was well tolerated among patients it was done.

in a recent interview with Dermatology Times®Christopher Bunick, MD, PhD, Associate Professor of Dermatology at Yale School of Medicine and Principal Investigator of the Yale CI Trial, said: This scale may cover many, if not all, parts of the body, and in moderate to severe cases the scales may be thick and slough off constantly.This presents an aesthetic problem. and others clearly perceive the scales and that the person has a “disease” and this leads to emotional challenges… There’s never a moment of rest when you’re not.”

Thirty-three patients entered the CONTROL trial and were randomized to TMB-001 0.05% (n=11), TMB-001 0.1% (n=10), or twice daily vehicle (n=12) and divided by the CI subtype. , 12 weeks. The primary CONTROL endpoint was the proportion of patients with a ≥50% reduction in visual index of ichthyosis severity (VIIS) scaling over baseline. The key secondary endpoint was his ≥2-grade reduction in the Investigator Global Assessment (IGA) scaling score relative to baseline. Of the 33 patients enrolled, 52% had ARCI and 48% had the XLRI subtype.

The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. The per-protocol (PP) population met inclusion criteria, adhered to treatment (≥80% to 120% of study drug applied), had VIIS scaling measures at the end of 12 weeks, and had no main protocol. included all patients with violation.

The main results of CONTROL are:

  • In the ITT population, 33%/50%/17% of ARCI patients and 100%/33%/75% of XLRI patients who received TMB-001 0.05%/TMB-001 0.1%/vehicle achieved VIIS, respectively. bottom. -50
  • In the PP population, 100%/33%/17% of ARCI patients and 100%/50%/75% of XLRI patients receiving TMB-001 0.05%/TMB-001 0.1%/vehicle achieved VIIS, respectively Did. -50
  • In the ITT population, 33%/50%/0% of ARCI patients and 83%/33%/25% of XLRI patients receiving TMB-001 0.05%/TMB improved IGA score by ≥2 grades. I was. -001 0.1%/vehicle
  • In the PP population, 100%/67%/0% of ARCI patients and 100%/50%/25% of XLRI patients receiving TMB-001 0.05%/TMB improved IGA score by ≥2 grades. I was. -001 0.1%/vehicle
  • The most reported adverse events were application site reactions and were similar in both subgroups

Alan Mendelsohn, MD, Chief Medical Officer of Timber Pharmaceuticals, noted that TMB-001 has been granted orphan designation for the ARCI and XLRI subtypes by the European Commission, and recent data from the sub-analyses , endorsing Timber’s evaluation of TMB-001. Current pivotal Phase 3 clinical trial.

reference

  1. Timber Pharmaceuticals announces the presentation of a sub-analysis of its Phase 2b CONTROL trial in Clinical and Experimental Dermatology. Wood medicine. Published March 20, 2023. Accessed March 22, 2023. Analysis-of-Phase-2b-CONTROL-study-in-Clinical-and-Experimental-Dermatology.html



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