Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.
Liz Doolin, Bionomics’ Vice President Clinical Development commented that “We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning. We look forward to continuing this partnership into the future.”
Bionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical-stage biopharmaceutical company. Bionomics said in their announcement:
“BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD).
The 7-day dosing PK study in ten healthy volunteers (females and males) demonstrated that at a dose of 900 mg given twice daily, the tablet formulation of BNC210 had steady-state 12-hourly exposure levels ranging from 33-57 mg.h/L which exceed the 12-hourly blood exposure of ~25 mg.h/L predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.
Dr. Errol De Souza, Executive Chairman of Bionomics said, “We are extremely pleased with the results of the 7-day PK study which demonstrate that we reach steady-state levels on the second day following the start of twice-daily dosing and that we not only meet but exceed the blood exposure predicted from the pharmacometrics analysis as necessary for future trials.
“With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021.”
Dr Kurt J. Sales Agilex Biolabs’ Director Immunoassay said: “Anxiety and stress-related disorders have a major impact on the health and wellbeing of hundreds of thousands of Australians with more than 1 in 4 people reported to be impacted by these disorders. The effects of stress and anxiety not only impact a person’s psychological well-being but also their physical well-being and productivity which in turn has a tremendous impact on the economy.
“Novel treatments such as BNC210 are essential weapons in the fight against anxiety and stress-related disorders. Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders.”
Agilex Biolabs’ world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR. The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilizing the two platforms of LC-MS/MS and Immunoassay.
Clients can also access a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity. Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff and supports client pharma and biotech companies from US, Europe and APAC.
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About Agilex Biolabs
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough here: https://youtu.be/WNdPGkdr9FA
Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilizing LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).
Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)
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