ASCEND Phase 3 TrialInterMune provided an update on patient enrollment in the company's Phase 3 "ASCEND" study, which is designed to confirm the efficacy and safety of pirfenidone and to support an NDA re-submission for FDA approval of Esbriet (pirfenidone) in the United States. The company now expects ASCEND to be fully enrolled around the end of 2012. InterMune's previous guidance was the second quarter of 2012.
Steve Porter, M.D., Ph.D., Chief Medical Officer for InterMune, said, "Our primary mission for ASCEND is to deliver a high-quality result, which we aim to achieve by concentrating on a select number of high-quality sites. While a number of factors have contributed to the extended timeline, we are firmly convinced that the trade-off between data quality and time is a very good one. We believe the trial design and refined entry criteria of ASCEND significantly increase our probability of a successful outcome because they provide that patients enrolled in the study have the characteristics that we know from our many studies in IPF predict disease progression. We are extremely pleased with the continued enthusiasm of IPF physicians for ASCEND and look forward to sharing the results at the end of the study."
InterMune noted that it will discuss the status and projected timing for completion of the ASCEND Phase 3 clinical trial of Esbriet during today's conference call and webcast.
About Esbriet® (pirfenidone) in FranceEsbriet is the first-ever drug approved by the EU regulatory authorities in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). In its assessment, the CT cited 7,700 mild-to-moderate IPF patients in France. The CT is the agency in France responsible for assessing medicinal products and advising the health authorities on whether those products provide sufficient benefit to be covered by French National Health Insurance. About SMR and ASMR Under the French system, a new medicine may be granted one of four SMR levels. Of these, three are considered "sufficient" for the CT to recommend favorable inclusion on the reimbursed drug list. The three sufficient SMR ratings are: Important, Moderate and Low. Each rating is associated with different levels of reimbursement. The fourth SMR level, "Insufficient," is a recommendation by the CT that is unfavorable to inclusion on the reimbursed drug list and if assigned to an application, no ASMR rating is given by the CT. In this case, the manufacturer does not proceed to price negotiations with the Pricing Committee (CEPS). There are five levels of ASMR rating:
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