Idorsia and J&J's jointly developed potential first-in-class dual endothelin receptor antagonist has produced positive phase 3 trial results in resistant hypertension.
Swiss biotech Idorsia (formerly Actelion) announced positive top-line results of PRECISION, the phase 3 study investigating aprocitentan for the treatment of patients whose blood pressure is not adequately controlled despite receiving at least triple antihypertensive therapy — known as resistant hypertension. Aprocitentan is an oral dual endothelin receptor antagonist which potently inhibits the binding of ET-1 to ETA and ETB receptors.
During the trial, aprocitentan significantly reduced blood pressure when added to standardized combination background antihypertensive therapy in patients with resistant hypertension over 48 weeks of treatment.
The biggest negative in the results appeared to be the rate of edema/fluid retention in patients treated with aprocitentan — approximately 30% of patients developed edema at one time point during the entire study duration, with >95% being mild to moderate in intensity. Seven patients discontinued treatment due to edema/fluid retention.
The drug represents a $230 million gamble taken by J&J on a market with a big opportunity — Idorsia estimates that by 2025, there could be approximately 10 million patients in the U.S. with resistant hypertension and a similar number of patients in Europe.
In late 2017, Janssen exercised its option to enter into a collaboration agreement with Idorsia to jointly develop and commercialize aprocitentan and any of its derivative compounds or products. Following Janssen's opt-in decision, Idorsia received a one-time milestone payment of $230 million. The terms of deal stipulated that Idorsia oversaw the phase 3 development and regulatory submission for the treatment of patients with resistant hypertension, with the costs will be shared equally between both partners. Janssen will oversee the phase 3 development and submission for any additional indications and will have the sole worldwide commercialization rights.
Idorsia said it will now discuss the results with health authorities with the aim to file the new drug application with the U.S. FDA by the end of the year, closely followed by other health authorities.
