Promentis Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders, today announced it has initiated dosing in a Phase 2 study for its lead compound, SXC-2023, for the treatment of moderate to severe trichotillomania in adults. Promentis is developing SXC-2023 along with other compounds that engage System xc-, a central nervous system target addressing glutamatergic imbalance and oxidative stress, to treat trichotillomania and other impulse control disorders, obsessive-compulsive disorder and other neuropsychiatric diseases.
The aim of the Phase 2 study is to evaluate the safety, tolerability and efficacy of three oral doses of SXC-2023 in adult patients with moderate to severe trichotillomania. Trichotillomania is a highly prevalent but underrecognized and disabling condition characterized by recurrent hair pulling, leading to noticeable hair loss and substantial adverse impact on quality of life. The Phase 2 trial, now underway in the United States, is a double-blind randomized study that will be conducted in 12 centers with a total of approximately 100 patients, divided into three active-dose cohorts and a placebo cohort. The study will examine measurements of trichotillomania symptom severity and also measures of overall patient mental health and well-being, as well as other cognitive parameters.
Promentis’ Phase 2 trichotillomania monotherapy trial will be followed by a Phase 2 add-on therapy trial in obsessive-compulsive disorder. Promentis announced the successful completion of its Phase 1 clinical studies in a press release dated November 16, 2018. Read the full story here.