Timber Pharmaceuticals to Present Interim Analyses From Phase 3 Clinical Trial
Timber Pharmaceuticals (NYSE American: TMBR) will present positive interim data from its Phase 3 ASCEND clinical trial evaluating a potential treatment for moderate to severe congenital ichthyosis (CI) at the Society for Pediatric Dermatology’s annual meeting.
The interim analyses indicate minimal systemic absorption of isotretinoin or its major metabolites in patients who were treated with TMB-001 0.05% ointment. The high-dose and chronic oral isotretinoin therapy required in the treatment of CI cannot be tolerated by many patients due to systemic toxicity.
These findings, when combined with the efficacy and safety findings to date, demonstrate that there is great potential to achieve similar efficacy results with topical TMB-001 as compared with oral isotretinoin in CI and potentially other conditions but without many of the safety issues associated with systemic retinoid therapy.
Highlights
Timber’s Phase 3 study is an ongoing double-blind, vehicle-controlled randomized 12-week study followed by 12 weeks of open label treatment of patients who are greater than 6 years of age with moderate to severe X-linked recessive CI (XLRI) or autosomal recessive CI (ARCI). A subset of patients is also participating in a 12-week open label Maximal Use Study (MuST) that includes the collection of PK data as well as safety and efficacy data.
The interim analysis of the pharmacokinetic (PK) data indicates minimal absorption of isotretinoin when TMB-001 0.05% is applied to 75-90% of the body surface as opposed to systemic exposure using oral isotretinoin.
Joyce M.C. Teng, M.D., Ph.D., Professor and Director of Pediatric Dermatology, Stanford University, said, “If we can overcome toxicity challenges of oral treatment with a novel topical formulation of isotretinoin, we may be able to provide better care for our patients.”
Full PK results will be presented during the Society for Pediatric Dermatology’s Annual Meeting to be held July 13-16, 2023, in Asheville, North Carolina.
Timber has been granted Breakthrough Therapy Designation and Fast Track Status by the FDA for TMB-001.
About Timber Pharmaceuticals
Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company’s investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is currently focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, please visit https://www.timberpharma.com/.
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