Promentis Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders, today announced it has successfully completed a behavioral biomarker study for its lead compound, SXC-2023, and has finished enrolling patients in a Phase 2 multi-center study in its first indication, trichotillomania. Promentis is developing SXC-2023 and other compounds that engage system xc-, a unique astrocytic central nervous system target that addresses glutamatergic imbalance to treat trichotillomania and other highly prevalent neuropsychiatric diseases marked by deficits in impulse control.
The principal aims of the now-completed Phase 2A behavioral biomarker study were to demonstrate psychodynamic activity and further evaluate the safety and tolerability of SXC-2023 in adult subjects. The study reveals a clear effect associated with SXC-2023 administration in measures of impulse control closely related to trichotillomania and other indications of interest to the Company, and reinforces the attractive safety profile of SXC-2023. The results indicate the potential benefits of SXC-2023 on important aspects of cognitive dysfunction implicated across a wide range of CNS disorders.
The aim of Promentis’ now fully-enrolled multi-center Phase 2 study in trichotillomania is to evaluate the efficacy, safety and tolerability of three oral doses of SXC-2023 in adult patients with moderate to severe trichotillomania. Trichotillomania is a highly prevalent but underrecognized impulse control disorder that has no approved treatments. It is characterized by recurrent hair pulling, leading to noticeable hair loss and a substantial adverse impact on quality of life. The Phase 2 trial is a double-blind randomized study conducted in 13 centers with more than 120 patients divided into four cohorts (three active-doses and a placebo). The study will examine measurements of trichotillomania symptom severity, impulsivity and cognitive parameters and measures of overall patient mental health and well-being. Read the full story here.