Congenital Birthmarks

Congenital Birthmarks

NFlection is developing a topical gel formulation of a proprietary “soft” (metabolically labile) MEK inhibitor for the treatment of disfiguring childhood birthmarks such as keratinocytic epidermal nevi and nevi sebacei.

Keratinocytic epidermal nevi and nevi sebacei develop during childhood and persist into adulthood. These birthmarks present as raised rough yellow or brown patches of skin and often occur in visible areas such as on the face, scalp, torso or extremities, causing cosmetic distress and anxiety for patients. Currently, these birthmarks can only be treated surgically or mitigated with lasers.

NFlection is developing a topical gel formulation of a proprietary “soft” (metabolically labile) MEK inhibitor

Studies by Dr. Kavita Sarin and colleagues at Stanford have demonstrated that nevi sebacei and the majority of keratinocytic epidermal nevi develop due to overactivation of the Ras/Raf/MEK/ERK signaling pathway, most commonly through activating mutations in HRAS, NRAS or KRAS. MEK inhibitors block Ras/Raf/MEK/ERK signaling downstream of these genetic alterations and represent a promising targeted therapeutic for these disfiguring birthmarks.

cellular slide

NFlection has demonstrated dose-dependent suppression of pERK, a biomarker of Ras/Raf/MEK/ERK pathway activation ex-vivo, after an NFlection discovered MEK inhibitor is applied to the surface of human nevus sebaceous and epidermal nevus explants. The MEK inhibitor formulation can penetrate into the epidermal layers of the skin to locally deliver the MEK inhibitor and inhibit the overactive Ras/Raf/MEK/ERK pathway in the birthmark. The soft MEK inhibitor rapidly degrades upon reaching systemic circulation to minimize the side effects caused by systemic exposure to MEK inhibitors.