CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human])

Rhea-AI Summary

CSL (ASX:CSL; USOTC:CSLLY) announces Phase 3 AEGIS-II trial results for CSL112, which did not meet primary efficacy endpoint of MACE reduction at 90 days. No immediate regulatory filing planned. Ongoing analysis to be presented at ACC Scientific Sessions in April 2024.

Positive

• None.

Negative

• CSL112 did not meet primary efficacy endpoint of MACE reduction at 90 days, leading to no near-term regulatory filing plans.

KING OF PRUSSIA, Pa., Feb. 11, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced top-line results from the Phase 3 AEGIS-II trial evaluating the efficacy and safety of CSL112 (apolipoprotein A-I [human]) compared to placebo in 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. 

"We look forward to sharing our scientific learnings regarding cholesterol efflux and recurrent cardiovascular events," said C. Michael Gibson, M.S., M.D., Baim Institute for Clinical Research, Harvard Medical School. "We will continue to analyze the findings and share the full results in the coming months."

Further analysis of AEGIS-II is ongoing and primary results will be presented at the American College of Cardiology Scientific Sessions, held April 6, 2024, and published in a peer-reviewed journal.

"Substantial work remains to fully analyze and understand the complete data and then to determine any development path ahead for this asset. We thank all the patients, families, caregivers, and investigators for their support and participation in the AEGIS program," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, for CSL. "AEGIS-II is the most ambitious study in our company's history and we are proud of the quality of the study we delivered and the enhanced capabilities we developed to do so. 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."

About AEGIS-II
The AEGIS-II trial is a Phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group study which evaluated the efficacy and safety of CSL112 in the reduction of recurrent cardiovascular events in the 90-day high-risk period that follows a heart attack. The study enrolled over 18,200 patients from over 850 sites in 49 countries. Participants were randomized to receive 4 weekly doses of CSL112 or placebo initiated within 5 days of first medical contact.

About CSL112
CSL112, Apolipoprotein A-I (Human), is an investigational cholesterol efflux enhancer, developed using a novel formulation of human plasma-derived apoA-I, the primary functional component of high-density lipoproteins (HDL).

About CSL 
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit www.CSL.com.

Media Contacts:
Greg Healy
Greg.Healy@cslbehring.com
+1 610 906 4564

Valerie Bomberger
Valerie.Bomberger@cslbehring.com
+1 610 291 5388

In Australia:
Bernadette Murdoch
Bernadette.Murdoch@csl.com.au
+61 449 950 745

Jimmy Baker
Jimmy.Baker@csl.com.au
+61 450 909 211

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SOURCE CSL

FAQ

What are the top-line results from the Phase 3 AEGIS-II trial for CSL112 (CSLLY)?

The study did not meet its primary efficacy endpoint of reducing the risk of major adverse cardiovascular events (MACE) at 90 days.

When will the primary results of the AEGIS-II trial be presented?

The primary results will be presented at the American College of Cardiology Scientific Sessions in April 2024.

Who is the Executive Vice President and Head of R&D for CSL?

Dr. Bill Mezzanotte is the Executive Vice President and Head of R&D for CSL.

What are the future plans for CSL regarding cardiovascular and metabolic conditions?

CSL plans to apply their capabilities and plasma protein platform to address unmet medical needs in cardiovascular and metabolic conditions.

What was the response to the study results from the Baim Institute for Clinical Research, Harvard Medical School?

Dr. C. Michael Gibson expressed interest in sharing scientific learnings regarding cholesterol efflux and recurrent cardiovascular events.

Were there any major safety concerns with CSL112 in the AEGIS-II trial?

There were no major safety or tolerability concerns with CSL112 in the trial.