The CSL Limited (ASX: CSL) share price is sinking after the biotech healthcare giant announced the disappointing result of its CSL112 trial.
What was reported?
CSL has received the top-line results from the phase 3 AEGIS-II trial evaluating the effectiveness and safety of CSL112.
The trial was randomised and placebo-controlled to judge whether CSL112 reduced the risk of major cardiovascular events (MACE) in the 90-day high-risk period after a heart attack.
This study enrolled over 18,200 patients from over 850 sites in 49 countries. Participants were randomised to receive four weekly doses of CSL112 or a placebo initiated within five days of first medical contact.
CSL said the study did not meet its primary efficacy endpoint of MACE reduction at 90 days. That’s not exactly a positive for the CSL share price. As a result, there are no plans for a near-term regulatory filing. But, the healthcare company did say there were no major safety or tolerability concerns with CSL112.
Commentary
Dr Bill Mezzanotte, executive vice president and head of research and development said:
Substantial work remains to fully analyse 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.
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.
What is the financial impact of this?
CSL pointed out that it excluded any financial contribution from CSL112 in its guidance and statements. It also said it doesn’t expect any material financial impact after the AEGIS-II trial conclusion.
The business said it would discuss CSL112 and the topline results of AEGIS-II when it releases its results on 13 February, which is tomorrow.
My thoughts on the CSL share price
I’m no expert on biotechnology, healthcare trials or things of that nature, so it’s hard to evaluate how much this should impact CSL shares, if at all.
I think CSL is a strong business, one of Australia’s best. But it has a relatively high price/earnings ratio (p/e ratio) considering how big it already is. There are plenty of other ASX growth shares I’d rather buy first.
