InterMune reports new data from Esbriet clinical trial on IPF

InterMune, Inc. (NASDAQ: ITMN) today reported that new data was presented at the European Respiratory Society (ERS) Annual Congress supporting the longer-term safety and tolerability of Esbriet^® (pirfenidone) in patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease.  Approximately 30,000-35,000 new IPF patients are diagnosed in Europe each year, with an estimated median survival of only two to five years. The announcement follows the recent marketing authorization of Esbriet in Europe and its first launch in Germany on 15 September.

Professor Ulrich Costabel, from the Department of Pneumology/Allergy at the Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany who presented the data, said: "These new data from the RECAP study show that the safety profile of pirfenidone remains consistent, even when pirfenidone treatment continued beyond three years, thereby adding to the growing body of evidence that supports the treatment of IPF with pirfenidone. This news should be welcomed by European clinicians who will soon have the opportunity to treat their mild to moderate IPF patients with this new medicine."

The RECAP extension study data, presented on 25 September at ERS, highlighted the positive longer-term safety and tolerability of Esbriet in patients with IPF. RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY.  The CAPACITY program (studies 004 and 006) was designed to evaluate the treatment effect of Esbriet in IPF patients. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.  

"IPF is a devastating condition with no proven management options other than lung transplantation, so we hope that this new longer-term safety data will reinforce the known safety and importance of Esbriet as the future standard of care for patients living with IPF," said Giacomo Di Nepi, InterMune's Senior Vice President and Managing Director, Europe.  "Germany is the first country in Europe where Esbriet is now available to patients, and we are glad to be able to offer now this new treatment opportunity to patients with mild to moderate IPF."

RECAP Study Results

At Week 72 in RECAP, mean exposure to pirfenidone 2403 mg/d across both studies was 2.9 years (range, 1-4); 114 patients had received Esbriet 2403 mg/d for at least three years.  The favorable safety and tolerability profile observed in CAPACITY and other prior clinical trials was confirmed in RECAP.

In RECAP, treatment-emergent adverse events (TEAE) and common adverse events (AEs) were very similar to those reported in CAPACITY:

• 98 percent of RECAP patients reported at least one TEAE compared to 99 percent in the treatment arm and 98 percent in the placebo arm of the CAPACITY program.
• In RECAP, 33 percent of patients had a serious TEAE compared to 33 percent in the treatment arm and 31 percent in the placebo arm during CAPACITY.
• The incidence of common AEs in RECAP was very similar to that observed in CAPACITY and these AEs were generally mild to moderate in severity.  The type and frequency of adverse events were generally consistent with observations from the Phase 3 clinical trials; no new safety signals or trends were observed.
• The overall incidence of photosensitivity or rash was lower in RECAP than in CAPACITY (20 percent of patients vs. 44 percent). Rash and photosensitivity reactions were more common among patients newly initiating treatment with pirfenidone compared with those who were continuing treatment (28 percent vs. 12 percent); however, the incidence was similar to that observed among pirfenidone-treated patients in the CAPACITY studies.