Novartis has announced that it will be acquiring Regulus Therapeutics in a deal worth $1.7bn, marking a notable boost to the drugmaker’s renal disease pipeline.
The agreement will give Novartis access to farabursen, a candidate in clinical development for autosomal dominant polycystic kidney disease (ADPKD).
In ADPKD, the most common genetic cause of renal failure, small fluid-filled cysts gradually develop in the kidneys.
Farabursen is an investigational microRNA inhibitor that aims to reduce the growth of cysts and kidney size, as well as delay progression of disease severity in patients with ADPKD.
The drug, which targets miR-17, recently demonstrated promising efficacy and safety results in a phase 1b multiple-ascending dose clinical trial.
According to Regulus, the candidate showed consistent impact on urinary polycystin, a biomarker of mechanistic response, and height-adjusted total kidney volume, a measure of progressive disease.
Shreeram Aradhye, president, development and chief medical officer, Novartis, said farabursen “represents a potential first-in-class medicine with a profile that may provide enhanced efficacy, tolerability and safety versus standard of care”.
“The team at Regulus has done meaningful foundational work with farabursen, and we look forward to investigating its potential further as we aim to bring a better treatment option to patients in need,” Aradhye added.
The transaction, which is expected to close in the second half of this year, includes an upfront payment of $800m and a potential $900m payment dependent on the achievement of a future regulatory milestone
Regulus’ chief executive officer, Jay Hagan, said: “We are excited to combine with Novartis to potentially bring farabursen to patients living with ADPKD, who currently have limited treatment options.
“Novartis’ established global development and commercial capabilities will enable this important new medicine to reach patients if approved.”
The announcement comes less than three months after Novartis revealed that it would be expanding its late-stage cardiovascular pipeline by acquiring Anthos Therapeutics for approximately $3.1bn.
The deal, expected to close in the first half of 2025, includes abelacimab, which is currently in phase 3 development for the prevention of stroke and systemic embolism in patients with atrial fibrillation.