Phase 2 study of Arikace for treatment of pseudomonas lung infections

Transave reported additional positive clinical trial results on its lead investigational drug, Arikace (liposomal amikacin for inhalation), an antibiotic to treat chronic lung infections.  The new Phase 2 data from a study in CF patients with Pseudomonas lung infection indicate that Arikace, delivered at a dose of 560 mg once daily for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by a significant and sustained improvement in lung function, improvement in patient reported outcomes and reduction in Pseudomonas density. Additionally, Arikace was well-tolerated with overall adverse events comparable to placebo. The latest results along with previously reported data demonstrate significant clinical benefits and complete the company’s Phase 2 program in two indications – for the treatment of lung infections due to the bacterium, Pseudomonas aeruginosa in cystic fibrosis (CF) patients and non-CF bronchiectasis patients.

The Phase 2 results were from a prospectively designed pooled analysis of two randomized, double-blind and placebo-controlled studies of 105 patients at 33 European and U.S. sites. Arikace and placebo were administered once daily using an eFlow Nebulizer System (PARI Pharma GmbH), a portable aerosol delivery system. Preliminary data from a third CF trial which is an on-going open label study where Arikace is being dosed in multiple cycles demonstrated continued improvement in lung function over repeat cycles.

Arikace is a formulation of the antibiotic amikacin, enclosed in nanocapsules of lipid called liposomes and delivered by the eFlow Nebulizer System. This formulation is designed to prolong the release of amikacin in the lungs while minimizing systemic exposure.  

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