Promentis Pharmaceuticals has started dosing patients in a Phase II trial of SXC-2023 for the treatment of adults with moderate to severe trichotillomania.
Trichotillomania is a disabling condition caused by regular, uncontrollable hair pulling that results in hair loss.
The Phase II trial is designed to examine the safety, tolerability and efficacy of three oral doses of SXC-2023 in patients.
The double-blind, randomised trial is being conducted at 12 centres in the US.
It aims to enroll around 100 patients, who will be divided into three active-dose and placebo cohorts.
The severity of trichotillomania symptoms, overall patient mental health and well-being, and other cognitive parameters will be assessed during the trial.
It will be followed by a Phase II add-on therapy trial evaluating SXC-2023 in obsessive-compulsive disorder.
Promentis Pharmaceuticals CEO Klaus Veitinger said: “We are very excited to commence our Phase II programme, rapidly following our Phase I results showing SXC-2023 to be very safe, well-tolerated and with a well-behaved PK profile.
“SXC-2023 presents the possibility of a ground-breaking new therapy and commencing our Phase II trials is an important step towards that goal.
“The mechanism and excellent safety profile of the drug show great promise in a wide variety of impulse control and other disorders, as monotherapy and in combination with other treatments.”
Promentis is currently developing SXC-2023 to treat trichotillomania, obsessive-compulsive disorder, and neuropsychiatric diseases.