Start-up biopharma Palladio Biosciences acquired global rights to Chiesi’s orally active, nonpeptide selective vasopressin V2 receptor antagonist lixivaptan, which had previously been developed by Cornerstone Therapeutics for treating hyponatremia, but which Palladio aims to repurpose for treating polycystic kidney disease (PKD). In parallel with acquisition of lixivaptan, its first drug candidate, Palladio closed a Series A venture round led by European life sciences venture capital firm Medicxi. No financial details have been disclosed.
“We believe that lixivaptan may be able to delay the progression of PKD, thus decreasing the need for dialysis and/or kidney transplant and potentially extending the lives of patients with PKD,” said Lorenzo Pellegrini, Ph.D., founder and CEO of Palladio.”
“We are excited to be supporting Palladio Biosciences,” added Michèle Ollier, M.D., partner and co-founder of Medicxi, who has been appointed to the Palladio board. “Lixivaptan represents a late-stage, derisked orphan development program in an area of high unmet need with no treatment approved in the U.S.”
Cornerstone Therapeutics had taken lixivaptan through clinical development for treating hyponatremia associated with congestive heart failure and syndrome of inappropriate antidiuretic hormone, but in 2012 the FDA issued the firm with a Complete Response Letter (CRL) to its submitted NDA. Chiesi subsequently bought Cornerstone outright in 2014, having previously held a 58% stake in the firm.
Palladio says preclinical and clinical data support the use of vasopressin V2 receptor antagonism for treating PKD. The firm aims to leverage the existing data package for lixivaptan, which includes 36 clinical trials, and learn from Otsuka Pharmaceutical’s experience developing the vasopressin V2 receptor antagonist tolvaptan for autosomal dominant PKD (ADPKD). Tolvaptan was approved in Japan in 2014, and in the EU in 2015; however, in 2013 the firm's submitted NDA to the FDA was met with a CRL, citing safety concerns. At the start of this week, Otsuka reported positive data from an additional Phase III study established to address the CRL.