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

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X WPharma: Avance Clinical, the largest premium Australian CRO for international biotechs, is pleased to share the news that its client XWPharma Ltd. has 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.

Avance Clinical is an award-winning Australian owned Contract Research Organisation (CRO) that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 24 years.

Avance Clinical CEO Yvonne Lungershausen congratulated XWPharma saying: “Avance Clinical has an international reputation for expediting clinical trials in Australia which has an exceptionally supportive regulatory environment for biotechs”.

“A key benefit for clients is that an IND is not required which means this is the fastest startup destination for international biotechs,” said Lungershausen.

According to XWPharma:

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.

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.

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