Boehringer Ingelheim commences new Ofev safety study

Boehringer Ingelheim has commenced a new study assessing the safety of its drug Ofev with pirfenidone as an add-on therapy.

Trial 1199.222 will be a 12-week study evaluating the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with Ofev in patients with idiopathic pulmonary fibrosis.

The trial's primary endpoint is the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12. It will be the first multinational study involving 100 patients to investigate add-on treatment with two approved idiopathic pulmonary fibrosis therapies.

Dr Christopher Corsico, corporate senior vice-president for medicine and chief medical officer at Boehringer Ingelheim, said: "The safety and wellbeing of patients is at the centre of everything we do. We are initiating this trial to ensure that we provide the scientific community with important information regarding Ofev combination therapy."

Previous studies have shown that Ofev can slow disease progression across a broad range of patient types, with an approximately 50 percent reduction in the decline of lung function.