CSL Behring’s major trial ends in disappointment After drug fails to reduce risk of heart disease

CSL Behring, a prominent player in the Australian pharmaceutical landscape, recently concluded its most extensive clinical trial to date, AEGIS-II, with results that didn’t meet the anticipated benchmarks. 

The focus of this trial was on evaluating the efficacy of CSL112, also known as apolipoprotein A-I, in reducing the recurrence of heart attacks among a sizable cohort of approximately 17,400 patients who had previously experienced heart attacks. The trial, conducted across 49 countries and initiated in 2018, represented a substantial investment on the firm’s part.

Initially conceptualized in 2017, CSL expressed optimism about CSL112’s potential to reshape the treatment landscape for heart attack survivors and improve health outcomes for millions worldwide at risk of recurrent cardiovascular events. However, the recent trial outcomes have tempered these expectations.

Despite the meticulous planning and execution, CSL disclosed disappointing outcomes on February 11, revealing that CSL112 did not demonstrate a significant reduction in the risk of major adverse cardiovascular events within the critical 90-day window compared to a placebo. 

As a consequence of this outcome, CSL stated that there are presently no plans for regulatory submission based on these findings. This disclosure has prompted a reevaluation of the drug’s future prospects.

While CSL refrained from divulging extensive specifics regarding the trial outcomes, the company did stress that there were no significant safety concerns associated with the drug. 

However, a more comprehensive analysis of the data is required to fully grasp the implications and potential future paths for CSL112. Dr. Bill Mezzanotte, CSL’s head of Research and Development, acknowledged the setback, emphasizing the importance of a thorough understanding of the trial’s complete dataset.

CSL112 was developed using a novel formulation of apoA-I, extracted from human plasma, with the aim of enhancing the body’s natural ability to remove cholesterol from arterial plaque. The hypothesis driving its development was that by bolstering this process, CSL112 could potentially reduce the occurrence of cardiovascular events among high-risk patients, particularly in the critical early phase following a heart attack.

In response to the announcement, CSL’s stock experienced a decline of approximately 5% when the Australian stock exchange opened following the disclosure. By the end of trading, CSL’s shares settled at 290.24 Australian dollars, marking a notable decrease from the previous closing price of AU$305.

Despite the setback represented by the AEGIS-II trial results, the company representative claims that CSL aims to harness the insights gleaned from this experience to inform future innovation efforts and contribute meaningfully to advancing patient care on a global scale.

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