Timber Pharmaceuticals Reports Positive Top-line Results from Phase 2b CONTROL Study Evaluating TMB-001 in Moderate to Severe Congenital Ichthyosis - Seite 2

Top-line results including descriptive statistics are described below: 

•  In the PP population, 100 percent (nominal p= .04) and 40 percent (nominal p= ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved VIIS-50 compared to 40 percent in the vehicle group.
•  In the ITT population, 64 percent (nominal p= 0.17) and 40 percent (nominal p= ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved VIIS-50 compared to 33 percent in the vehicle group.
•  In the PP population, 100 percent (nominal p=.002) and 60 percent (nominal p=ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved a ≥2 point improvement in the IGA at week 12 compared to 10 percent in the vehicle group.
•  In the ITT population, 55 percent (nominal p=.02) and 40 percent (nominal p=ns) of patients treated with TMB-001 0.05% and 0.1%, respectively, achieved a ≥2 point improvement in the IGA at week 12 compared to 8 percent in the vehicle group. 
•  TMB-001 was generally well tolerated with a similar incidence of adverse events (AEs) across treatment groups. The most frequent AEs were local adverse effects common for such topical treatments. There were no treatment-related serious adverse events (SAE). 

“We are extremely pleased with the encouraging data generated by the Phase 2b CONTROL study of TMB-001. The study was not powered or intended to show statistical significance, but we demonstrated clinically meaningful efficacy with a favorable safety profile that support the continued development of our lead product candidate,” said John Koconis, Chairman and Chief Executive Officer of Timber. “We look forward to additional study data and plan to present the full data set at scientific congresses or peer-reviewed journal publication in the near future.”

“These topline results demonstrate the potential of TMB-001 to be an important option for the treatment of CI where no FDA-approved treatments are currently available and the standard of care is limited to the use of emollients or keratinolytics to reduce scaling and dryness,” said Alan Mendelsohn, M.D., Chief Medical Officer of Timber. “We are committed to fulfilling the unmet need of CI patients and continuing to develop TMB-001 as quickly as possible. I would like to thank all of those who helped us to rapidly advance the CONTROL trial during the pandemic including the outstanding team of investigators and clinical sites and particularly the patients who participated in the study.”