XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases

Redwood City, California, UNITED STATES

Phase 1 Results Demonstrate Optimal Pharmacokinetics, with Rapid Oral Absorption, Prompt Release of Oxybate from the New Chemical Entity XW10172, and Sustained Duration at Desired Plasma Concentrations Suitable for Once-Nightly Dosing

Data Support Continued Development of XW10172; Phase 2 Trial in Sleep Disorders in Patients with Parkinson’s Disease is planned to start 3Q2021 followed by Single Registrational Trial in Narcolepsy

Results Selected for Podium Presentation at SLEEP 2021, the Annual Meeting of the Associated Professional Sleep Societies

REDWOOD CITY, Calif. and WUHAN, China, June 14, 2021 (GLOBE NEWSWIRE) -- XWPharma Ltd. today announced that XW10172, an internally discovered, novel, patented conjugate of the GABAB agonist oxybate, demonstrated in Phase 1 clinical trials multiple features that support development for treatment for various sleep disorders. The results of these studies were presented by Daniel Canafax, PharmD, Chief Medical Officer of the company, in a podium presentation at virtual SLEEP 2021, the annual meeting of the Associated Professional Sleep Societies.

“We are excited to have this opportunity at the SLEEP 2021 meeting to share promising clinical data from our lead drug candidate, XW10172,” said Leonard Blum, XWPharma’s President and CEO. “We are extremely encouraged by these Phase 1 results, which support XW10172 as an innovative treatment to address the debilitating symptoms and underlying fragmented sleep architecture seen in patients with sleep disorders that are common across many CNS disease states. In addition, we believe these results reflect the strength of our expertise in novel chemistry, neurobiology, and development that enable the creation of drugs that are uniquely fit for purpose and will make a difference in patients’ lives.”

“For patients with a variety of sleep disorders, these results establish desired drug properties, including a favorable safety profile and optimal pharmacokinetics suitable for once-nightly dosing of XW10172,” said Dr. Canafax. “Based on these data, we believe the drug offers potential as treatment in sleep disorders in patients with Parkinson’s disease and patients with other neurodegenerative diseases, for which no drugs are currently indicated despite the high unmet medical need. Additionally, once-nightly dosing and the absence of sodium are features that support XW10172 as potential best-in-class treatment for patients with narcolepsy.”

In healthy volunteers an immediate-release oral formulation of XW10172 was rapidly absorbed and metabolized to release oxybate at concentrations that matched equal molar doses of sodium oxybate, currently approved for treatment of narcolepsy. In addition, XW10172 was generally well-tolerated and adverse events seen are known effects of oxybate. Reports of somnolence, which is the desired pharmacological effect of XW10172, showed a concentration-effect relationship.

In a crossover study in healthy subjects that evaluated multiple time-based modified-release formulations of XW10172, each of these formulations delivered oxybate at concentrations considered to be effective at promoting sleep, increasing slow wave sleep, and consolidating sleep stages that are associated with improved sleep quality and reductions in excessive daytime sleepiness and cataplexy. The modified-release formulations maintained those desired concentrations over 6-7 hours following oral ingestion. Concentrations quickly declined below target levels 7-8 hours after dosing, the desired waking time.

These data support progression of XW10172 for further clinical evaluation. The Company plans to initiate a Phase 2 study in the coming months in patients with Parkinson’s disease suffering from sleep disorders, followed by a single Phase 3 pivotal study in narcolepsy patients.

The abstract and poster presentation of these data can be found on the SLEEP 2021 website at https://www.sleepmeeting.org/.

About Sleep Disorders in Neurodegenerative Diseases

Hypersomnia is a common, debilitating chronic neurological condition in patients with neurodegenerative diseases, particularly Parkinson’s disease. Among patients with Parkinson’s disease fragmented, non-restorative sleep at night, followed by daytime fatigue and uncontrolled excessive daytime sleepiness, are among the most frequently cited and burdensome consequences of the condition. One etiology in these patients is abnormal sleep architecture characterized by reduced total sleep time, reduced slow wave sleep and increased, disruptive REM episodes throughout the night. Oxybate has been shown in several clinical studies in patients with narcolepsy to normalize sleep architecture by increasing slow wave sleep, reducing REM episodes, and decreasing awakenings, leading to reduced excessive daytime sleepiness. Two investigator-initiated trials have reported sodium oxybate to be effective in treating excessive daytime sleepiness in patients with Parkinson’s disease and improved sleep architecture.

About XW10172

XW10172 is a novel, patented, new chemical conjugate of the GABAB receptor agonist, oxybate, that is in development as a modified-release formulation for once-nightly dosing. The drug and formulation are designed to deliver oxybate without high sodium content that is associated with increased cardiovascular health risk and patient monitoring requirements. XWPharma plans to develop XW10172 for treatment of sleep disorders in patients with neurodegenerative diseases, starting with excessive daytime sleepiness in patients with Parkinson’s disease, as well as cataplexy and excessive daytime sleepiness in patients with narcolepsy.

About Virtual SLEEP 2021

Virtual SLEEP 2021 is the annual meeting of the Associated Professional Sleep Societies, LLC (APSS), which is a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). Virtual SLEEP 2021 is the 35th annual meeting of the APSS. For additional information about SLEEP 2021 visit www.sleepmeeting.org

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

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