Promentis Pharmaceuticals Announces Commencement of Phase 2 Studies for SXC-2023 Targeting Novel Glutamatergic Mechanism

MILWAUKEE, Jan. 17, 2019 /PRNewswire/ -- 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 x_c-, 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.

About Promentis Pharmaceuticals

Promentis Pharmaceuticals, Inc. is a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders. Promentis' drug development efforts are focused on a unique approach to addressing glutamatergic imbalance and oxidative stress. The Company's first indication is trichotillomania, a highly prevalent disorder for which there is no approved therapy, and for which there are no other known treatments in development.

Promentis is led by Klaus Veitinger, M.D., Ph.D. (CEO, Chairman of the Board for Promentis and OrbiMed Venture Partner). The team also includes Tom Beck, M.D. (Chief Medical Officer and Board Member for Promentis and F-Prime Capital Executive Partner), Daniel Lawton (President and Board Member) and Chad Beyer, Ph.D. (Senior VP R&D).

About Trichotillomania and Other Obsessive-Compulsive and Addictive Disorders

Obsessive-compulsive and related disorders, as defined by DSM-5, represents a broad category of neuropsychiatric disease, including OCD, excoriation (skin-picking) disorder and trichotillomania. Trichotillomania is a disabling and underrecognized condition characterized by recurrent hair pulling despite repeated attempts to stop the behavior, leading to noticeable hair loss. Trichotillomania is associated with a range of psychosocial problems, including low self-esteem, social anxiety, avoidance of intimacy, occupational impairment and an overall decrease in quality of life. In addition, a significant number of trichotillomania patients ingest their hair after pulling, which can lead to life-threatening gastrointestinal blockages requiring surgery. 

Alterations in glutamate signaling within brain regions implicated in urge control and executive function have been proposed to contribute to the underlying pathology of trichotillomania, as well as other obsessive-compulsive disorders, addictive disorders and other CNS conditions. No medications are approved by the US Food and Drug Administration for the treatment of trichotillomania, nor are there any other known treatments in development. For more information regarding trichotillomania, see: https://promentispharma.com/technology/trichotillomania.  

Contact: Tiberend Strategic Advisors, Inc.

Janine McCargo, 646-604-5150,  [email protected]

SOURCE Promentis Pharmaceuticals, Inc.