Zerion Pharma A/S announces positive results from the first human clinical study of a Dispersome® formulation of the drug Ivacaftor, a pharmaceutical used to treat cystic fibrosis. The study was conducted by ZERION’s Spanish partner Insud Pharma, a global leader in generic and branded pharmaceuticals.
The clinical study was a comparative oral bioavailability pilot study designed to assess the pharmacokinetic parameters of two different Ivacaftor Dispersome® formulations relative to the approved product Kalydeco® 150 mg film-coated tablets (Ivacaftor). Ivacaftor is formulated as a polymeric amorphous solid dispersion in Kalydeco®.
The study was conducted as a crossover study with the participation of 18 subjects (healthy volunteers). One of the Ivacaftor Dispersome® formulations showed improved bioavailability compared to the reference product, while the pharmacokinetic parameters for the second formulation were equivalent to Kalydeco®. Both Ivacaftor Dispersome® formulations carried high content (drug load) of Ivacaftor and were designed to increase the solubility of this poorly soluble compound.
ZERION announced its collaboration with Insud Pharma in August 2022. The Ivacaftor Dispersome® product is the first product originating from the collaboration that has been investigated in a human clinical trial.
Ivacaftor is used to treat cystic fibrosis in patients with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is also used in combination with other drugs such as tezacaftor and elexacaftor to treat people with cystic fibrosis.
