BRISBANE, Calif., May 12, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that several investigational molecules and data from studies of pirfenidone will be presented at the 2014 International Conference of the American Thoracic Society (ATS), May 16 21, in San Diego, Calif. in a total of 18 abstracts. Updates on InterMune’s small molecule fibrosis research programs, including pirfenidone analogs and inhibitors of LPA1 and LOXL2, will be presented at the meeting. Additionally, data will be presented from studies of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF), including the primary efficacy and safety analyses of the Phase 3 ASCEND trial, as well as other data that further characterize the safety profile of pirfenidone.
“The data at this conference demonstrate our commitment to discovering and developing new treatments for fibrotic diseases,” said Dr. Jonathan Leff, Executive Vice President of Research and Development at InterMune. “With pirfenidone, we are making strong progress in our mission to help IPF patients. Pirfenidone is the most extensively studied and well-characterized drug for IPF and, we are excited that at ATS, 27 presentations on pirfenidone will be made by InterMune or others. We also look forward to sharing data on our growing research programs exploring new targets and pathways that may ultimately lead to improved treatment options for people with IPF and other fibrotic diseases.”
InterMune noted that important presentations of data regarding pirfenidone in IPF patients will be presented on both Sunday, May 18 and Tuesday, May 20. The company plans to conduct live webcasts on each of those days. Additional information regarding the webcasts is detailed below.
Pirfenidone-Related Presentations:
The ASCEND Study: A Randomized, Double-Blind, Placebo-Controlled Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF), Publication Page: A6602, Mini Symposium [A95] SKYFALL: Late Breaking Clinical Trials in Idiopathic Pulmonary Fibrosis
Oral presentation at 2:55 p.m. on Tuesday, May 20, Session Time 2:00 p.m. 4:30 p.m., Ballroom 20 B-C, Upper Level, San Diego Convention Center
ASCEND is a Phase 3 multinational, randomized, double-blind, placebo-controlled trial designed to confirm the effect of pirfenidone on disease progression in patients with IPF. The presentation will consist of a full presentation of results from this study, including sensitivity analyses on the primary endpoint of change in percent predicted forced vital capacity (FVC).
Analysis of Pooled Data from Three Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Trials Evaluating Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF), Publication #A1423, Poster Board #A11
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area A, Hall B2-C, Ground Level, San Diego Convention Center
Two, Phase 3 multinational studies in patients with IPF (CAPACITY; studies 004 and 006) evaluated the treatment effect of pirfenidone on forced vital capacity (FVC), progression-free survival, 6-minute walk distance, dyspnea and mortality. A third Phase 3, multinational, randomized, controlled trial evaluating pirfenidone in 555 patients with IPF (ASCEND; study 016) has recently been completed and evaluated the same endpoints. Analysis of pooled data on these endpoints from CAPACITY and ASCEND will be presented.
Effect of Treatment with Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF): A Meta-Analysis of Five Randomized, Double-Blind, Placebo-Controlled Clinical Trials, Publication #A1429, Poster Board #A17
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area A, Hall B2-C, Ground Level, San Diego Convention Center
Pirfenidone has been evaluated in five randomized, double-blind, placebo-controlled trials, including three Phase 3 multinational trials, ASCEND (Study 016), CAPACITY (Studies 004 and 006) and two Japanese trials (SP2 and SP3). A meta-analysis of data from these five trials (n=1,573 patients) was conducted to determine the effect of pirfenidone on slowing the decline in FVC and improving progression-free survival among IPF patients with mild-to-moderate impairment in lung function.
Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF): Integrated Analysis of Data from Four Clinical Trials, Publication #A1422, Poster Board #A10
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area A, Hall B2-C, Ground Level, San Diego Convention Center
A comprehensive analysis of safety across four clinical trials (CAPACITY 004 and 006 and two ongoing open-label studies 002 and 012) evaluating pirfenidone in patients with IPF (n=789)was conducted and will be reported.
Pirfenidone Use in Clinical Practice: Analysis of Data from a Canadian Patient Support Program for Patients with Idiopathic Pulmonary Fibrosis (INSPIRATION), Publication #A1428, Poster Board #A16
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area A, Hall B2-C, Ground Level, San Diego Convention Center
Persistency and adherence outcomes for a cohort of patients (n=308) taking pirfenidone and participating in an InterMune Canadian nursing patient support program called “Inspiration” will be reported.
Nonclinical Studies Suggest Simple Strategies to Further Improve the GI Tolerability of Pirfenidone, Publication #A1420, Poster Board #A8
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area A, Hall B2-C, Ground Level, San Diego Convention Center
Abstracts Related to InterMune’s Research Programs:
Discovery of ITMN-30162: A Pirfenidone Analog with Improved Pharmacokinetics, Anti-Fibrotic Efficacy and Potential for Reduced Gastric Side Effects, Publication #A1953, Poster Board #C8
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area A, Hall B2-C, Ground Level, San Diego Convention Center
Optimized analogs of pirfenidone represent novel chemical agents that may advance the treatment of IPF and other fibrotic conditions. Performance of lead compounds ITMN-30162 and ITMN-14440 in animal models of pulmonary fibrosis and in a model of gastrointestinal side effects will be presented.
Discovery and Anti-Fibrotic Activity of Novel Antagonists of Lysophosphatidic Acid Receptor 1 (LPAR1), Publication #A2018, Poster Board #C77
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area C, Hall B2-C, Ground Level, San Diego Convention Center
Lysophosphatidic acid (LPA), through stimulation of its G-protein coupled receptor LPAR1, has been identified as an important mediator of fibrosis. The performance characteristics of ITMN-10534, a potential best-in-class small molecule LPAR1 antagonist, will be described. ITMN-10534 is an IND-development candidate and is now advancing towards the clinic.
Identification of Novel Small-Molecule LOXL2 Inhibitors by High Throughput Screening, Publication #A2020, Poster Board #C79
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area C, Hall B2-C, Ground Level, San Diego Convention Center
Lysyl oxidase (LOX) and lysyl oxidase-like protein 2 (LOXL2) are needed for the biosynthesis of normal mature extracellular matrices during development and wound healing. However, over-expression of LOXL2 is observed in various cancers and fibrotic disease states, including IPF. An anti-LOXL2 monoclonal antibody (simtuzumab) is in Phase 2 studies for IPF and other indications. This study presents the results of a high throughput screening (HTS) campaign, which identified novel first-in-class small molecule LOXL2 inhibitors. The most potent compounds from seven chemically diverse series were tested and results will be presented.
Plasma Protein Signature of Idiopathic Pulmonary Fibrosis (IPF), Publication Page: A3923, Mini Symposium
Oral presentation at 8:45 a.m. on Tuesday, May 20, Session Time 8:15 a.m. 10:45 a.m., Room 1 A-B, Upper Level, San Diego Convention Center
Matrix Metalloproteinase (MMP)-7 Predicts Mortality in Idiopathic Pulmonary Fibrosis (IPF), Publication Page: A3924, Mini Symposium
Oral presentation at 9:00 a.m. on Tuesday, May 20, Session Time 8:15 a.m. 10:45 a.m., Room 1 A-B, Upper Level, San Diego Convention Center
The Influence of Concurrent Emphysema on Pulmonary Function Decline in Idiopathic Pulmonary Fibrosis, Publication #A1427, Poster Board #A15
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area A, Hall B2-C, Ground Level, San Diego Convention Center
Integrated Baseline and Longitudinal Mortality Risk Prediction in Idiopathic Pulmonary Fibrosis, Publication #A1446, Poster Board #A36
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area A, Hall B2-C, Ground Level, San Diego Convention Center
Impact of LPA and LPA1 Receptor Antagonists on Gene and Protein Expression in Human Primary Cells, Publication #A2016, Poster Board #C75
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m., Area C, Hall B2-C, Ground Level, San Diego Convention Center
Small-Molecule and Peptide Activators of the Nrf2-Dependent Antioxidant Response Element, Publication #A2019, Poster Board #C78
Poster session on Sunday, May 18, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area C, Hall B2-C, Ground Level, San Diego Convention Center
Phenotypic Screening for Inhibitors of Fibroblast to Myofibroblast Transition (FMT), Publication #4920, Poster Board #G51
Poster session on Tuesday, May 20, Session Time 8:15 a.m. 4:30 p.m., Poster Viewing 10:45 a.m. 12:30 p.m. in Area G, Hall B2-C, Ground Level, San Diego Convention Center
Genome-wide Imputation Study Identifies New Genetic Loci for Pulmonary Fibrosis, Publication #A5263, Poster Board #801
Poster session on Tuesday, May 20, Session Time 2:00 4:30 p.m., Poster Viewing 2:00 p.m. 3:00 p.m., Discussion 3:00 p.m. 4:00 p.m. in Indigo Ballroom E, Level 2, Hilton San Diego Bayfront
Genetic Variants Associated with Pulmonary Fibrosis in Asian and Hispanic Populations, Publication #A5568, Poster Board #501
Poster session on Wednesday, May 21, Session Time 8:15 a.m. 10:45 a.m., Poster Viewing 8:15 a.m. 9:15 a.m., Discussion 9:15 a.m. 10:45 a.m. in Room 30 A-B, Upper Level, San Diego Convention Center
Conference Call and Webcast Details Sunday, May 18 and Tuesday, May 20
InterMune will host a live webcast Sunday, May 18 at 5:00 p.m. PDT (8:00 p.m. EDT) to discuss pirfenidone in IPF. Interested investors and others may participate in the conference call by dialing 844-825-0513 (U.S.) or 484-365-2934 (international), conference ID# 43717876. A replay of the webcast and teleconference will be available approximately two hours after the call.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 855-859-2056 (U.S.) or 404-537-3406 (international), and entering the conference ID# 43717876.
Additionally, InterMune will host a live webcast on Tuesday, May 20 at 5:00 p.m. PDT (8:00 p.m. EDT) to discuss additional pirfenidone data in IPF. Interested investors and others may participate in the conference call by dialing 844-825-0513 (U.S.) or 484-365-2934 (international), conference ID# 43741688. A replay of the webcast and teleconference will be available approximately two hours after the call.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 855-859-2056 (U.S.) or 404-537-3406 (international), and entering the conference ID# 43741688.
To access either webcast, please log on to the company’s website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
About InterMune
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, irreversible, unpredictable and ultimately fatal lung disease. Pirfenidone is approved for marketing by InterMune in the EU and Canada under the trade name Esbriet®. Pirfenidone is not approved for sale in the United States. 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.
Forward-Looking Statements
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 InterMune’s expectations with respect to the information that it intends to present during the American Thoracic Society meeting, and the potential of InterMune’s research programs to produce drug candidates that lead to improved treatment options for people with IPF and other fibrotic diseases, including as best-in-class or first-in-class treatments. 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 24, 2014 (the “Form 10-K”) 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, in particular in connection with our planned resubmission of a Class 2 NDA with the FDA seeking approval of pirfenidone or other government regulation generally; (iv) risks related to our ability to successfully launch and commercialize pirfenidone in the United States, if approved by the FDA and (v) InterMune’s ability to obtain or maintain patent or other proprietary intellectual property protections. 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 and InterMune’s other periodic reports filed with the SEC, all of which are available via InterMune’s web site at www.intermune.com.
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SOURCE InterMune, Inc.
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