InterMune Reports New Analyses from the RECAP Study of Esbriet® (pirfenidone) at ERS
InterMune Reports New Analyses from the RECAP Study of Esbriet® (pirfenidone) at ERS
VIENNA, Sept. 3, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) announced that new analyses of data from the RECAP extension study of Esbriet® (pirfenidone) were presented today at the 2012 Annual Congress of the European Respiratory Society (ERS) in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.
The RECAP study is an ongoing open-label extension study evaluating the long-term administration of Esbriet in patients who completed InterMune's Phase 3 CAPACITY program. The CAPACITY program (studies 004 and 006) was designed to evaluate the safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function.
Dr. Costabel presented new analyses of Forced Vital Capacity (FVC) and survival in patients who received placebo in CAPACITY and were newly treated with Esbriet in RECAP. These analyses show that patients with mild-to-moderate IPF newly-treated with Esbriet in RECAP for 60 weeks had similar FVC and survival outcomes when compared to those treated with Esbriet for the same duration in CAPACITY.
Dr. Costabel commented, "The population in this RECAP analysis represents the fourth large, well-defined cohort of IPF patients to be treated with pirfenidone and followed prospectively for more than one year. FVC and survival outcomes in the RECAP patients treated with pirfenidone were highly consistent with those in pirfenidone-treated patients in three previous randomized, controlled Phase 3 studies. While these data should be interpreted with due regard to the limitations inherent to the open-label study design of RECAP, the results provide further support for the role of Esbriet in the treatment of patients with this devastating disease.
Methods of the Analyses
The new analyses are based on the patients who received placebo in the CAPACITY studies and therefore first received Esbriet in RECAP. To facilitate comparison to outcomes in the CAPACITY trials, the analyses focused on the patients who at the time of entry into RECAP had baseline FVC and DLco values that would have met the original eligibility criteria for CAPACITY. Of the 274 newly treated patients in RECAP, 178 met the CAPACITY FVC and DLco criteria and were included in the analyses.
Results of the Analyses
The first analysis examined the proportion of patients at Week 60 with an FVC decrement of 10% or greater, an outcome that is highly clinically relevant and predictive of mortality. Analysis of pooled data from CAPACITY demonstrated that treatment with Esbriet resulted in a 32% reduction in the percentage of patients who experienced an FVC decrement of at least 10% at week 60 (p=0.011). A comparison of outcomes in patients newly treated with Esbriet in RECAP showed similar results: the proportion of patients who experienced a 10% or greater decline in FVC at week 60 was 16.3% among patients newly treated with Esbriet in RECAP, compared with 16.8% in the Esbriet group in CAPACITY. The proportion of placebo-treated patients meeting this criterion in CAPACITY was 24.8%.
The second analysis was based on the mean change from baseline in percent predicted FVC in the entire population of patients. The analysis of data at week 60 showed that the mean change in percent predicted FVC in patients newly treated with Esbriet in RECAP was -5.8%; the mean change over the corresponding interval during CAPACITY was -7.0% in patients treated with Esbriet and -9.4% in patients treated with placebo. Analysis of data at earlier time points also showed very similar results between patients newly treated with Esbriet in RECAP and those originally treated with Esbriet in CAPACITY.
The last analysis examined overall survival from baseline to week 60 in patients newly treated with Esbriet during RECAP. While neither RECAP nor CAPACITY was powered to evaluate the effect of treatment on survival, analyses showed that overall survival at 60 weeks post initiation of therapy was similar in patients newly treated with Esbriet in RECAP and CAPACITY, and greater than that of patients who were treated with placebo in CAPACITY. Additionally, fewer treatment emergent deaths, defined as deaths occurring within 28 days of the last dose of study drug, were observed among Esbriet-treated patients in both RECAP and CAPACITY compared with patients who were treated with placebo during CAPACITY. Treatment-emergent death occurred in 3.4% and 2.9% of Esbriet-treated patients in RECAP and CAPACITY, respectively, compared with 5.8% of patients treated with placebo in CAPACITY.
These results, coupled with new results to be presented at ERS during a poster discussion session on Tuesday, September 4 on the long-term safety data in IPF patients treated with Esbriet for up to 7.7 years, provide further evidence to support the clinical efficacy and safety 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 safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function. 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.
Long-term safety results from RECAP were initially presented at the Annual Congress of the European Respiratory Society (ERS) in September 2011. These results demonstrated that long-term treatment with Esbriet was safe and generally well-tolerated, with a long-term safety profile similar to that observed in CAPACITY.
About Esbriet® (pirfenidone)
Esbriet is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
On February 28, 2011, the European Commission granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. Esbriet is commercially available in Austria, Denmark, Germany, Iceland, Luxembourg, Norway and Sweden.
InterMune is conducting a Phase 3 study, ASCEND, to support the regulatory registration of Esbriet for the treatment of IPF in the United States and expects to complete patient enrollment of the study around the end of 2012.
Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease characterized predominantly by fibrosis (scarring) in the lungs, hindering the ability for gas exchange in the lungs. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. Additional information about the study is available at www.ASCENDtrial.com. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to the role of Esbriet in the treatment of patients with IPF and our expectation regarding the timing and nature of full enrollment in the ASCEND study and the prospects of success thereof to support regulatory registration of Esbriet for the treatment of IPF in the United States. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form 10-K"), most recent quarterly report on Form 10-Q filed with the SEC on August 8, 2012 (the "Form 10-Q") and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; and (iv) risks related to our ability to successfully commercialize Esbriet in the EU. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K, Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.