TMB-001, a proprietary topical formulation of isotretinoin currently being evaluated in a Phase 2b clinical trial for the treatment of moderate to severe subtypes of congenital ichthyosis (CI), a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. A prior Phase 1/2 study involving 19 patients with CI demonstrated safety and preliminary efficacy of TMB-001, as well as minimal systemic absorption. In 2018, the U.S. Food & Drug Administration (FDA) awarded $1.5 million to support clinical trials evaluating TMB-001 through its Orphan Products Grant program.
TMB-002, a proprietary topical formulation of rapamycin currently being evaluated in a Phase 2b clinical trial for the treatment of facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), a multisystem genetic disorder resulting in the growth of hamartomas in multiple organs. TSC results from dysregulation in the mTOR pathway, and as a topical mTOR inhibitor, TMB-002 may address FAs in TSC without the systemic absorption of an oral agent.
TMB-003, a proprietary formulation of sitaxsentan, a new chemical entity in the U.S., which is a selective endothelin-A receptor antagonist currently in preclinical development as a topical or subcutaneous agent for the treatment of localized scleroderma, a rare autoimmune connective tissue disorder (CTD) that leads to inflammation and thickening of the skin.
