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.

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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.

“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 severity of trichotillomania symptoms, overall patient mental health and well-being, and other cognitive parameters will be assessed during the trial.

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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.