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.
“We are very excited to commence our Phase 2 program, rapidly following our Phase 1 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 2 trials is an important step towards that goal” said Klaus Veitinger, CEO of Promentis. “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.”
Glutamatergic dysfunction is a hallmark feature of many neuropsychiatric indications, including a broad range of impulse control disorders (ICDs), which is Promentis’ initial therapeutic focus.
Promentis’ first ICD monotherapy indication is trichotillomania, a condition characterized by recurrent hair pulling, leading to noticeable hair loss and substantial adverse impact on quality of life. Functional deficits in glutamate signaling within the cortical-striatal pathway and mesolimbic system have been proposed to contribute to the underlying pathology and symptoms of trichotillomania. Trichotillomania is more common in women than men and has been estimated to affect more than 1% of the US population. No medications are approved by the US Food and Drug Administration for the treatment of this chronic disorder.
An add-on treatment for obsessive-compulsive disorder is the company’s second indication, and the company is also exploring additional CNS indications where glutamatergic imbalance and oxidative stress contribute to impaired functioning.
Source: Company Press Release