US-based clinical stage pharmaceutical company Menlo Therapeutics has begun enrolling patients for two new Phase ll trials of a novel neurokinin 1 (NK-1) receptor antagonist, serlopitant, to treat pruritus (itch) associated with atopic dermatitis and pruritus following burn injury.
Pruritus is a frequent symptom of various dermatological and systemic conditions, which has not been sufficiently addressed by existing therapies.
The ATOMIK trial, one of the proposed Phase ll trials of serlopitant, is a multi-centre, randomised, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of serlopitant as a treatment to reduce pruritus associated with atopic dermatitis, a common skin condition characterised by itchy and inflamed skin.
For ATOMIK, around 450 subjects will be enrolled at more than 40 clinical sites in the US.
The second study, AUBURN, is a multi-centre, randomised, placebo-controlled study evaluating the efficacy, safety, and tolerability of serlopitant for pruritus following burn injury.
The trial will enrol around 150 patients at approximately 20 clinical sites in the US.
In August last year, Menlo Therapeutics signed an exclusive licence agreement with Japan Tobacco (JT) and Torii Pharmaceutical for the development and commercialisation of serlopitant in Japan.
Serlopitant has already showed antipruritic effects in a Phase ll clinical trial in patients with severe, chronic pruritus conducted by Menlo Therapeutics.