Calliditas is set to acquire a controlling interest in French biotech Genkyotex, gaining access to its lead primary biliary cholangitis (PBC) asset in the process.
Calliditas will acquire 62.7% of Genkyotex in an initial payment of €20.3m, expected to close in early October. The company will then seek to acquire all outstanding Genkyotex shares, with a total acquisition cost of approximately €32.2m as well as up to €55m in contingent rights.
The additional payments are dependent on the success of setanaxib (GKT831), Genkyotex’s lead clinical candidate which is currently in development for PBC, a chronic liver disease caused by progressive destruction of the bile ducts in the liver.
In a phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity and also possessed a favourable tolerability level, as well as a statistically significant effect on fatigue. The drug is also being evaluated in a phase 2 clinical trial in type 1 diabetes and kidney disease, and a further phase 2 trial of the drug in IPF is scheduled to recruit patients over the course of 2020.
Genkyotex will be eligible to receive €30m on approval of setanaxib for a first indication by the US Food and Drug Administration, as well as another €15m dependent on the drug’s first approval by the European Commission. A further €10m will be payed following the approval by the FDA or EC in either idiopathic pulmonary fibrosis (IPF) or type 1 diabetes.
Genkyotex’s platform identifies small molecules which can selectively inhibit specific NOX enzymes that amplify multiple disease processes including fibrosis, inflammation, pain processing, cancer development and neurodegeneration. Setanaxib, a NOX1 and NOX4 inhibitor, has potential in a range of fibrotic indications, according to Genkyotex.
“We believe Genkyotex’s novel NOX inhibition technology may have broad clinical utility not just in PBC, but as a platform therapy with the potential to target other fibrotic indications, including primary sclerosing cholangitis (PSC), selected kidney diseases and idiopathic pulmonary fibrosis (IPF), in which an investigator-led phase 2 trial is expected to start recruitment later this year,” said Renée Aguiar-Lucander, chief executive officer at Calliditas.