XWPharma Initiates First-in-Human Studies of XW10508, in Development for Fast-acting Relief of Treatment-Resistant Depression and Chronic Pain

XW10508 is an oral, once-daily therapy and novel analog of esketamine, designed for improved tolerability, intended to provide prompt efficacy following initiation of treatment, and featuring potential abuse-deterrent properties

Phase 1 trial is a multi-part study in healthy subjects to assess safety, tolerability and pharmacokinetics of XW10508 in immediate release and modified release formulations at ascending doses

REDWOOD CITY, CA, USA and WUHAN, China I September 08, 2021 I XWPharma Ltd. today announced dosing of subjects in its first-in-human study evaluating XW10508, the Company’s novel, patented, glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy for the treatment of treatment-resistant depression and chronic pain.

Over 264 million people worldwide suffer from major depressive disorders and roughly one-third of these patients are considered treatment-resistant, having failed two or more antidepressants. Additionally, one in five people worldwide experience chronic pain, while 8% of Americans suffer from chronic pain that frequently limits life or work activities. XW10508 is a new chemical entity derived from esketamine, designed for extended release, that is intended to deliver efficacy associated with esketamine in these populations without triggering the transient side effects that often accompany intranasal or intravenous administration.

“We are pleased to be dosing subjects in this Phase 1 study of XW10508, as we continue to execute on multiple programs across our innovative CNS drug pipeline,” said Leonard Blum, President and CEO of XWPharma. “Despite available therapies for treatment-resistant depression and chronic pain, many patients are unable to find adequate relief. In the case of depression, standard of care therapy can require the patient to take four to eight weeks of therapy before noting benefits. There remains a glaring need for an agent that can provide a rapid response after the initiation of treatment, particularly for patients in crisis. The abuse potential and safety risks associated with many highly effective pain treatments also drive demand for new solutions.”

The company’s Chief Medical Officer, Daniel Canafax, added, “Intravenous ketamine has been used with success in clinical practice for many years to treat depression and various pain states. The drug is given under physician supervision because of acute side effects including dissociation and sedation. Our vision is XW10508 will not produce these side effects by avoiding the high concentrations after IV ketamine while maintaining the drug exposure that produces antidepressant and analgesic effects.”

The Company anticipates initial results from this study in early 2022, which will allow for rapid progression into a Phase 2a test of safety and efficacy in patient cohorts.

About XW10508

XW10508 is a novel conjugate of esketamine in development as an oral, once-daily therapy for treatment-resistant major depression and various chronic pain states, for which ketamine and its enantiomer, esketamine, have accumulated broad evidence of efficacy and safety in clinical studies and clinical use. XW10508, in its modified release form offers improved tolerability upon administration, prompt onset of relief and lasting efficacy with potential abuse-deterrent properties. Preclinical studies of XW10508 have demonstrated increased oral bioavailability compared to esketamine in animal species, as well as a stable and predictable profile in formulation as sustained release. Despite leveraging a well-known and validated mechanism of action, XW10508 features novel properties and is a new chemical entity (NCE) with composition of matter protection extending until 2038.

About XWPharma

XWPharma is a biopharmaceutical company dedicated to the discovery and development of novel therapeutics, utilizing its proprietary platform chemistry. XWPharma's expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases. XW10172 is a clinical-stage conjugate of the GABAB agonist, oxybate, in development as an investigational once-nightly therapy intended to regulate the patient’s sleep cycle in order to alleviate excessive daytime sleepiness and other consequences of sleep dysfunction associated with neurodegenerative diseases, including patients with Parkinson’s disease or patients with narcolepsy. XW10508 is a glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy with potential abuse deterrent properties, designed for the treatment of major depressive disorder and chronic pain.

For additional information about XWPharma, visit: www.xwpharma.com

SOURCE: XWPharma

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