Clinical Trials Resource Center

Pulmonary Fibrosis

November 16, 2015

Boehringer Ingelheim Pharmaceuticals has issued results of three new post-hoc analyses from the phase III INPULSIS trials of OFEV (nintedanib) across various patient populations with idiopathic pulmonary fibrosis (IPF). All studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150mg twice daily to placebo for 52 weeks. In total, 160 patients (OFEV 98, placebo 62) were enrolled from U.S. clinical trial sites, while 901 patients (OFEV 540, placebo 361) were enrolled in clinical trials sites outside the U.S. Annual rate of decline in forced vital capacity (FVC) in U.S. patients was 94.7mL/year with OFEV and 242.5mL/ year with placebo (difference of 147.8mL/ year [95% CI: 56.1, 239.4]) while in non-U.S. patients it was 117mL/year with OFEV and 220mL/year with placebo (difference of 103mL/year [95% CI: 66.2, 139.7]). The hazard ratio for time to first acute exacerbation was 0.37 (95% CI: 0.06, 2.12) in U.S. patients and 0.68 (95% CI: 0.41, 1.15) in non-U.S. patients, both in favor of OFEV. Adverse events were reported in 100% and 98.4% of U.S. patients; and 94.6% and 88.1% of non-U.S. patients in the OFEV and placebo groups, respectively. The FDA has approved OFEV for the treatment of IPF.

June 3, 2013

Promedior reported results a phase Ib trial of PRM-151 for the treatment of idiopathic pulmonary fibrosis (IPF). This randomized, double-blind, placebo-controlled study enrolled 21 subjects with IPF. Subjects received PRM-151 doses of 1mg/kg, 5mg/kg or 10mg/kg, or placebo, administered intravenously on days 1, 3, 5, 8 and 15. Subjects were followed for 57 days after receiving their first dose. Subjects who received PRM-151 showed a measurable increase in lung function from baseline, as quantified by percent predicted FVC at eight weeks. The percent predicted FVC for patients dosed with PRM-151 showed a mean increase from baseline of 2.4% at eight weeks; in contrast, patients who received placebo had a mean 1.5% decrease from baseline. Percent predicted FVC increased by 10% from baseline in three of the 14 patients receiving PRM-151, and by 5% in three additional patients receiving PRM-151. In addition, the mean total distance walked in the six-minute walk test increased by 8 meters in PRM-151 treated patients and declined by 10.5 meters in placebo patients. The mean DLCO decreased by 1.79% in PRM-151 treated patients and by 2.33% from baseline in placebo patients. All doses of the drug were well tolerated. Promedior plans to initiate clinical development of PRM-151 in myelofibrosis.

May 23, 2011

Promedior reported results from a phase I trial of PRM-151 for idiopathic pulmonary fibrosis (IPF). This randomized double blind, placebo controlled study initially enrolled 26 healthy subjects who received single intravenous doses of PRM-151 from 0.1mg/kg to 20mg/kg. After completion of dosing of the healthy subjects, three subjects with IPF were administered a single dose of 10mg/kg intravenously. Single doses of PRM-151 up to 20mg/kg were safe and well tolerated in both populations. Analysis of efficacy biomarkers comparing the healthy versus IPF subjects showed a 50% reduction of CD45+/collagen-1+ fibrocytes within peripheral blood of all IPF subjects at 24 hours, and fibrocytes remained suppressed for up to 21 days in the majority of subjects. Analysis also indicated that elevated serum IL-6 levels observed at baseline in the IPF subjects decreased up to 50% (P<0.05) when measured 48 hours after PRM-151 dosing.

March 13, 2006

Amarillo Biosciences reported positive interim results of a clinical trial of their orally administered formulation of low-dose interferon alpha (IFNa), for the treatment of idiopathic pulmonary fibrosis (IPF), at the Southern Regional Meeting of the Society for Clinical Investigations in Atlanta. Results to date indicated that low dose IFNa was well tolerated, with no serious adverse events reported. The regimen was shown to stabilize IPF or produced minimally progressive disease in 10 of 12 subjects who received the drugs for at least 12 months; two subjects had experienced disease stabilization of over 24 and 48 months respectively. This ongoing open-label study has enrolled 20 subjects to date, who received 150 u IFNa via oral lozenge thrice daily. Based on these results, the company announced plans to submit a phase II protocol and an Orphan Drug application for the drug to the FDA.

December 5, 2005

Actelion reported negative results of their phase III BUILD-1 trial of Tracleer (bosentan) for the treatment of idiopathic pulmonary fibrosis (IPF). Trial data failed to demonstrate a significant improvement in distance walked in a 6 minute walk exercise test vs. placebo, the trial's primary endpoint. Secondary data were also non-significant, but did yield a positive trend in the combined incidence of death or treatment failure (worsening of pulmonary function tests or acute IPF decompensation) at 12 months (22.5% for bosentan, vs. 36.1% for placebo; p=0.076). This randomized, double-blind, placebo-controlled, multi-center study enrolled 158 patients, who were treated with the drug or placebo for 12 months. Based on these results, the company announced plans to investigate the drug's ability to reduce mortality in an additional trial.

May 9, 2005

InterMune and Shionogi have reported positive interim results of a phase II trial of pirfenidone, for the treatment of idiopathic pulmonary fibrosis. Positive results from the first 9 months were observed in the study's primary efficacy endpoint, with a trend towards improvement in change in lowest oxygen saturation during a 6-minute exercise test in the overall population (p=0.072), and a significant effect in the subset of patients with milder disease (p=0.0305). Significance in several secondary endpoints was also achieved, including change from baseline in vital capacity (p=0.0366), categorical assessment of the proportion of patients who improved, were stable, or declined (p=0.0028), and portion of patients experiencing acute symptom exacerbations requiring hospitalization (0%, vs. 14% for placebo; p=0.0031). One placebo patient died due to symptom exacerbation. The overall positive trend in data and the worsening of symptoms in the placebo group led the trial's independent Data Safety Monitoring Board (DSMB) to halt the trial early after this planned 9-month interim analysis. This randomized, double-blind, placebo-controlled study enrolled 107 subjects in Japan, and was originally scheduled to have a 12 month treatment period. Following these positive results, InterMune announced plans to meet with the FDA to discuss the design of upcoming phase III trials, which are expected in the first half of 2006.

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