Boehringer Ingelheim Pharmaceuticals announced the launch of a new clinical trial to investigate the effects of Ofev (nintedanib) on certain blood biomarkers that might help identify fibrosis and loss of lung function in idiopathic pulmonary fibrosis (IPF) patients.
“We are proud to initiate INMARK as it is the first study to investigate the effects of an IPF treatment on biomarkers that may be predictive of IPF progression,” said Dr. Martina Flammer, the company’s vice president of Clinical Development and Medical Affairs Specialty Care, in a press release. “In a disease that displays variable rates of progression, identification of biomarkers that could allow physicians to identify and monitor individual disease progression and treatment successes in patients with IPF is essential. We hope that the identification of these biomarkers, particularly early in the disease, has the potential to improve treatment and enable better delivery of patient care.”
The study INMARK will measure biomarkers (substances that assist doctors in predicting disease prognosis) that reflect substances linked to extracellular matrix (ECM) turnover. Uncontrolled or excessive ECM leads to scarring and decreased lung function. By examining values and changes from baseline, researchers believe it might be possible to determine biomarkers with most active fibrosis and determine their potential response to Ofev.
INMARK will analyze Ofev’s effect on the change rate of ECM turnover biomarkers against placebo effect, in IPF patients. The study will be conducted in Australia, Asia, Europe and North America across different patient populations.
Two-thirds of the 350 expected enrolled patients will be given placebo treatment for the first 12 weeks. One-third will receive Ofev for these first 12 weeks at 150 mg, two times daily. After the initial 12 control weeks, all patients will continue the trial with Ofev for 40 weeks to allow active treatment for patients who had only received placebo for the initial period of the trial.
“Despite advances in IPF, physicians are still uncertain when to start treatment because there are differences in disease progression across IPF patients. Biomarkers may inform us on how the disease will progress in Ofev-treated patients and identify earlier response prior to showing definitive pulmonary function changes,” Dr. Imre Noth, professor of medicine and director of the Interstitial Lung Disease Program at the university of Chicago, said in the press release. “The INMARK™ study may provide important insights for physicians on the impact of Ofev treatment on specific IPF biomarkers in patients with preserved lung function.”