CSL's Phase 3 AEGIS-II trial did not meet primary efficacy endpoint. Picture Getty
Health & Biotech
CSL (ASX:CSL) has today released the much-anticipated top-line results from the Phase 3 AEGIS-II trial, evaluating the efficacy and safety of CSL112 compared to placebo.
The CSL112 drug is a treatment for reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction (AMI).
The study did not meet its primary efficacy endpoint of MACE reduction at 90 days.
As a result, there are no plans for a near-term regulatory filing.
There were no major safety or tolerability concerns with CSL112, and CSL said it will continue to analyse the findings and share the full results in the coming months.
“Substantial work remains to fully analyse and understand the complete data and then to determine any development path ahead for this asset,” said Dr Bill Mezzanotte, executive vice president, head of R&D, for CSL.
Mezzanotte adds that AEGIS-II is the most ambitious study in the company’s history.
“We plan to apply these capabilities as well as our plasma protein platform to future unmet medical need in cardiovascular and metabolic conditions as well as those in our other strategic therapeutic areas,” he said.
The CSL share price was down -5% at the time of writing.
Argenica Therapeutics (ASX:AGN) has provided an update on its Phase 2 trial in acute ischaemic stroke (AIS) patients.
Firstly, AGN says the manufacturing and release testing of the GMP grade ARG-007 drug has been successfully completed, ready for patient dosing in the upcoming Phase 2 clinical trial.
The ARG-007 drug product and saline placebo will arrive at clinical trial sites across Australia in February, ready for patient dosing in March.
Argenica continues to work with its trial sites across Australia, and has now added Gold Coast and Royal Brisbane & Women’s Hospitals in Queensland as clinical trial sites.
Sunshine Hospital in Melbourne meanwhile has been removed as a trial site, due to logistical challenges identified in transporting patients from the facility into a thrombectomy centre.
Site initiation visits will commence this month, enabling clinical trial sites to be ready to start recruiting and dosing patients into the trial.
The company says dosing of first patients is on track to commence in March.
Ovarian cancer diagnostics company, Cleo Diagnostics (ASX:COV), confirmed that it has concluded design transfer activities relating to the core technology of its ovarian cancer detection test.
Cleo has now completed the design transfer of the CXCL10 active ratio test device into a more rigorous laboratory environment, ensuring the capability to deliver reproducible results.
This advancement will enhance the performance of the test, transitioning it from academic methodologies to a compliant and robust laboratory setting.
The completion of the design transfer also means it will progress the technology transfer to a manufacturer as the next step.
After that, the test will continue to progress through the FDA development pathway, which should culminate in an FDA 510K application for regulatory approval.
The CXCL10 active ratio measures changes in a key immune process to give an indication of the presence of a tumour.
The company is currently finalising a tender process for the selection of an antibody manufacturer, and expects to announce a partner by the end of the quarter.
Health & Biotech
Health & Biotech
Health & Biotech
