Cardiorentis raises $60M as PhIII heart failure trial nears completion

Cardiorentis has raised CHF 60 million ($60 million). The investment bolsters the biotech's bank balance at a time when it is nearing the end of a Phase III trial of its drug for acute decompensated heart failure (ADHF), data from which are due to be submitted to regulators later this year.

Zug, Switzerland-based Cardiorentis tapped three new, unnamed private investors for the Series B round, which comes two years after the company reached a €45 million financing agreement with HealthCare Royalty Partners to bankroll the start of its Phase III trial. The trial completed enrollment in May, setting Cardiorentis up to aim to make regulatory submissions in the second half of this year. Cardiorentis will use the fresh investment to wrap up the trial of its treatment for ADHF, Ularitide, and funnel what is left into the creation of a commercial operation to sell the product.

Having picked up FDA fast-track status last month, Cardiorentis has started laying the groundwork so it can make it quick start should data from the Phase III trial win favor with regulators. Brent Furse, a pharma veteran whose career includes spells at The Medicines Company ($MDCO), Bristol-Myers Squibb ($BMY) and Schering-Plough, has come on board as global chief commercial officer. Furse is joined on the leadership team by Reto Wittwer, another new hire who has taken on the CFO role having previously worked his way through the ranks at Novartis ($NVS) and its Sandoz subsidiary.

The new hires will contribute to efforts by Cardiorentis to turn Ularitide into a commercial success. Ularitide is based on urodilatin, a hormone that increases renal blood flow, enabling the kidneys to cope with a sudden worsening of symptoms associated with heart failure. Cardiorentis thinks that by synthesizing a version of urodilatin suitable for intravenous infusion, it can trigger a pathway that leads to the relaxation of smooth muscle tissues, which, in turn, results in vasodilation and an uptick in blood flow. The company thinks this could improve outcomes for patients who present with ADHF.

Data to back up the concept are due in the spring. The more than 2,000 patients enrolled into the trial were all given a 48-hour infusion of either Ularitide or a placebo shortly after being assessed for ADHF in an emergency room. Cardiorentis is hoping to see an improvement in trial participants in the treatment arm after 6, 24 and 48 hours. This is one of two co-primary endpoints. The second endpoint is assessing whether participants die from cardiovascular-related conditions in the 180 days following treatment. 

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