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Avance Clinical Client 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

By July 9, 2021July 13th, 2021Client News

The leading Australian CRO for international biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client XWPharma on receiving positive results from its Phase 1 clinical trial of XW10172.

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.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

“We are very pleased with the positive results announced by XWBiolabs on their product XW10172. Our team has been responsible for the trial management, monitoring, biometrics and medical writing elements of this trial. These results provide further validation of Avance’s strong reputation and deep expertise in executing early phase clinical trials which include pharmacokinetic endpoints as part of the trial’s main objectives.”

According to XWPharma:

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 XWPharma www.xwpharma.com

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.

See the full announcement here https://www.globenewswire.com/news-release/2021/06/14/2246472/0/en/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.html

About Avance Clinical
Avance Clinical is the largest full-service Australian CRO delivering quality clinical trials in Australia and New Zealand for international biotechs.

Avance Clinical has been delivering CRO services in the region for the past 24 years.

The company’s clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.

Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach.

As a company Avance Clinical has focussed on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of our technology partners.

The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field.

Visit https://www.avancecro.com for more information.

Recent Awards:

Excellence in Business Award 2021

Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

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