Company on Track to Initiate Phase 3 Development Program in 2015
ANN ARBOR, MI, USA I August 17, 2015 I Esperion Therapeutics, Inc. (ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, provided an update today from the ETC-1002 (bempedoic acid) End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) last week. The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD), who are already taking maximally tolerated statins yet require additional LDL-C reduction and where there is a positive benefit/risk ratio. Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT). The Company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.
Esperion remains on track to initiate the ETC-1002 Phase 3 development program by the end of 2015. The program will support a proposed label indication for the use of ETC-1002, an oral, once-daily LDL-C lowering therapy, “as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH), or atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C.” Approximately nine million patients in the U.S. fall into these two combined categories.
The ETC-1002 Phase 3 development program will include clinical studies in patients with ASCVD and HeFH. The study designs will be finalized once minutes from the FDA meeting are received. The Company plans to continue to evaluate ETC-1002 as an add-on to statins, including at all doses.
In the fourth quarter, Esperion plans to finalize development plans for the fixed-dose combination of ETC-1002 and ezetimibe and will file a separate Investigational New Drug (IND) application with the FDA.
“After an informative and collegial meeting with the FDA, we are pleased that LDL-C remains an accepted clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patients with HeFH and/or patients with ASCVD,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We have a clear regulatory path forward for development and approval of ETC-1002, an oral, once-daily treatment option for these patients that require additional LDL-C lowering.”
Esperion’s management will host a conference call to discuss these updates. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 15397722. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the Company’s website for two weeks.
Esperion’s Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002), one product candidate entering into clinical evaluation (a fixed-dose combination of ETC-1002 and ezetimibe), as well as two preclinical product candidates.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-C lowering therapies for the treatment of patients with hypercholesterolemia. ETC-1002 (bempedoic acid), the Company’s lead product candidate, is an inhibitor of ATP Citrate Lyase, a well-characterized enzyme on the cholesterol biosynthesis pathway; the same pathway that includes HMG-CoA reductase, the enzyme target of statins. ETC-1002 and statins have a similar mechanism of action, inhibiting cholesterol biosynthesis, decreasing intracellular cholesterol, up-regulating LDL-receptors, and causing increased LDL-C clearance and reduced plasma levels of LDL-C. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
SOURCE: Esperion Therapeutics
Post Views: 153
Company on Track to Initiate Phase 3 Development Program in 2015
ANN ARBOR, MI, USA I August 17, 2015 I Esperion Therapeutics, Inc. (ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of patients with hypercholesterolemia, provided an update today from the ETC-1002 (bempedoic acid) End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) last week. The FDA confirmed that LDL-C remains an acceptable clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD), who are already taking maximally tolerated statins yet require additional LDL-C reduction and where there is a positive benefit/risk ratio. Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial (CVOT). The Company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction.
Esperion remains on track to initiate the ETC-1002 Phase 3 development program by the end of 2015. The program will support a proposed label indication for the use of ETC-1002, an oral, once-daily LDL-C lowering therapy, “as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH), or atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C.” Approximately nine million patients in the U.S. fall into these two combined categories.
The ETC-1002 Phase 3 development program will include clinical studies in patients with ASCVD and HeFH. The study designs will be finalized once minutes from the FDA meeting are received. The Company plans to continue to evaluate ETC-1002 as an add-on to statins, including at all doses.
In the fourth quarter, Esperion plans to finalize development plans for the fixed-dose combination of ETC-1002 and ezetimibe and will file a separate Investigational New Drug (IND) application with the FDA.
“After an informative and collegial meeting with the FDA, we are pleased that LDL-C remains an accepted clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patients with HeFH and/or patients with ASCVD,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We have a clear regulatory path forward for development and approval of ETC-1002, an oral, once-daily treatment option for these patients that require additional LDL-C lowering.”
Esperion’s management will host a conference call to discuss these updates. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing access code 15397722. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at investor.esperion.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the Company’s website for two weeks.
Esperion’s Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002), one product candidate entering into clinical evaluation (a fixed-dose combination of ETC-1002 and ezetimibe), as well as two preclinical product candidates.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-C lowering therapies for the treatment of patients with hypercholesterolemia. ETC-1002 (bempedoic acid), the Company’s lead product candidate, is an inhibitor of ATP Citrate Lyase, a well-characterized enzyme on the cholesterol biosynthesis pathway; the same pathway that includes HMG-CoA reductase, the enzyme target of statins. ETC-1002 and statins have a similar mechanism of action, inhibiting cholesterol biosynthesis, decreasing intracellular cholesterol, up-regulating LDL-receptors, and causing increased LDL-C clearance and reduced plasma levels of LDL-C. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.
SOURCE: Esperion Therapeutics
Post Views: 153
