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- Bempedic acid is an oral ATP citrate lyase (ACL) inhibitor to be taken once a day, which reduces the synthesis of cholesterol and fatty acids in the liver.
- Bipedoic acid significantly reduced LDL cholesterol (LDL-C) compared to placebo at week 12 (primary endpoint, absolute reduction to -36 mg / dL, -21.4%)
- Over a 24-week period, bempedic acid was well tolerated and the rate of muscle-related adverse events did not differ from that of placebo.
- Treated patients had lower rates of onset or worsening of diabetes compared with those on placebo
MUNICH and ANN ARBOR, Michigan, April 2, 2019 PRNewswire / – Daiichi Sankyo Europe GMbH (hereinafter "Daiichi Sankyo") and Esperion Therapeutics (NASDAQ: ESPR) today announced the results of the double-blind, Phase 3, treatment of 345 patients, of a duration of 24 weeks, controlled study of bempedic acid (CLEAR Serenity, also called study 3) were published in the Journal of the American Heart Association (JAHA). Bipedoic acid is being developed as a complementary and convenient oral therapy once a day for the treatment of patients with low-density lipoprotein (LDL-C) cholesterol. The New Drug Applications for Biodedic Acid and the Bipedoic Acid / Ezetimibe Tablet are under regulatory review with a view to their marketing authorization by the European Atomic Energy Agency. drugs (EMA) and have been submitted to the US Food and Drug Administration (FDA).
The JAHA publication highlights that bempedoic acid has reached the primary endpoint of efficacy and has significantly reduced LDL-C by 21% (absolute reduction to -36 mg / mg). dL) after 12 weeks.1
The publication also presents the main efficacy endpoints at 12 and 24 weeks as well as the safety and tolerability results, demonstrating that bempedic acid:1
- Significant 24% reduction in hsCRP, an important marker of underlying inflammation badociated with cardiovascular disease;
- showed numerically fewer muscle-related adverse events compared to placebo (BA 12.8% vs. placebo 16.2%);
- has been observed to be well tolerated;
- showed numerically fewer new cases of diabetes or worsening of diabetes compared to the placebo group (BA 2.1% vs 4.5% placebo).
In the group of patients with statin intolerance, CLEAR Serenity demonstrates that bempedoic acid reduces LDL-C significantly more than placebo Patients on Bempedic acid reported less frequent occurrences of myalgia and muscle weakness These results demonstrate that bempedoic acid may offer a well tolerated and effective oral therapeutic option, particularly for the millions of patients requiring LDL-C reduction but having difficulty tolerating statin therapy. because of muscle-related side effects, "said Ulrich Laufs, MD, PhD.
"For patients who have experienced adverse events commonly attributed to statin therapy and who can not or will not take statins, there is an urgent need to significantly reduce their LDL-C and hsCRP levels. The CLEAR Serenity study in the Journal of the American Heart Association further demonstrates that bapeboic acid could be a well-tolerated and effective treatment option for patients with hypercholesterolemia, including those considered intolerant. to statins, "said Wolfgang Zierhut, MD, Head of the Department of Antithrombotic and Cardiovascular Medical Affairs of Daiichi Sankyo Europe.
Design of the third phase 3 global study (1002-046, also known as CLEAR Serenity)
The randomized, randomized, double-blind, placebo-controlled, Phase 3, multi-center, worldwide phase 3 trial evaluated the efficacy of LDL-C reduction and the safety of the patient. Boseboic acid 180 mg / day versus placebo in combination with lipid-modifying DMARD in hypercholesterolemic patients who are considered statin intolerant. The study was conducted at 67 sites in the United States and Canada. A total of 345 patients were randomized 2: 1 to receive bempedic acid or placebo. The primary efficacy goal was to evaluate the efficacy of bempedic acid against LDL cholesterol for 12 weeks compared with placebo. Secondary objectives included evaluation of the efficacy of bempedoic acid on 24-week LDL-C reduction over placebo and its effects on other risk markers after 12 weeks of treatment, including hsCRP . Safety and tolerability have been badessed by continuous monitoring of patients.
Fixed dose combined tablet of bempedic acid and ezetimibe
Due to the complementary mechanisms of action of inhibiting the synthesis of cholesterol (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the tablet badociated with a fixed dose Biodedic acid / ezetimibe is a non-statin, available orally, administered once daily, lowering LDL-C at least once a day therapy. Inhibition of ATP Citrate Lyase (ACL) by bempedoic acid reduces cholesterol biosynthesis and decreases LDL-C by positively regulating the LDL receptor. Inhibition of ezetimibe on Niemann-Pick C1-Like 1 (NPC1L1) results in a reduction in the absorption of cholesterol by the gastrointestinal tract, which reduces cholesterol intake to the liver, which in turn upregulates LDL receptors. Phase 3 data showed that this well tolerated combination resulted in a 35% reduction in LDL-C when used with maximally tolerated statins, a 43% reduction in LDL-C alone and a 34% reduction in the high sensitivity of C-LD. reactive protein (hsCRP). The rates of adverse events occurring during treatment, muscle-related adverse events and discontinuations were similar in the groups treated with bempedoic acid and placebo.2
Bipedoic acid
Due to its targeted mechanism of action, bempedoic acid is a single oral single dose ATP citrate lyase (ACL) inhibitor administered once daily. It reduces the biosynthesis of cholesterol and fatty acids, as well as LDL-C by positively regulating LDL receptors. . Just like statins, bempedoic acid also reduces highly sensitive C-reactive protein (hs-CRP), a key marker of inflammation badociated with cardiovascular disease.3 Biodedic acid is a prodrug that requires activation with very long-chain acyl-CoA synthase-1 (ACSVL1). In addition, it has been shown that the absence of skeletal muscle ACSVL1 provides a mechanistic basis for bempedoic acid to potentially avoid the myotoxicity badociated with statin therapy.4 Phase 2 and 3 studies in nearly 4,800 patients and approximately 3,100 patients treated with bempedic acid resulted in a further 20% reduction in LDL-C when they were used with maximally tolerated statins, up to 30% reduction of LDL-C monotherapy, 35% reduction of LDL-C in combination with ezetimibe when it is used with maximally tolerated statins and reduction of up to 48% of LDL-C in combination with ezetimibe monotherapy.5 The rates of adverse events occurring during treatment, muscle-related adverse events and discontinuations were similar in the groups treated with bempedoic acid and placebo.3
The effect of bempedoic acid on cardiovascular morbidity and mortality has not yet been determined. The company has launched a global trial on cardiovascular outcomes to evaluate the effects of bempedic acid on the occurrence of major cardiovascular events in patients with cardiovascular disease or with a history of cardiovascular disease. high risk of cardiovascular disease, which can only tolerate less than the minimum dose exposure. approved daily starting dose of a statin and considered "statin intolerant". CVOT – known as CLEAR Outcomes – is a randomized, double-blind, placebo-controlled, placebo-controlled, placebo-controlled study that is expected to include approximately 12,600 patients with hypercholesterolemia and high risk CVD in approximately 30 countries.6
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to creating and delivering innovative pharmaceutical products that address the diverse and unmet medical needs of patients in both mature and emerging markets. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees worldwide have a rich heritage of innovation and a strong portfolio of promising new drugs. to help the people. In addition to a strong portfolio of drugs for hypertension and thrombotic disorders, the Daiichi Sankyo Group is focused on becoming a "global pharmaceutical innovator with competitive advantages in oncology", as well as innovative new treatments in oncology, including: 39, immuno-oncology, with emphasis on new areas such as pain management, neurodegenerative diseases, heart and kidney diseases and other rare diseases. For more information, please visit: www.daiichisankyo.com.
Escrow commitment to patients with hypercholesterolemia
High levels of LDL-C can lead to fat and cholesterol build-up in and on artery walls (called atherosclerosis), potentially leading to cardiovascular events, including a heart attack or stroke. In the United States, 96 million people, or more than 37% of the adult population, have high LDL-C levels. In the United States, approximately 18 million people with atherosclerotic cardiovascular disease (ASCVD) live with high levels of LDL-C despite the treatment maximally tolerant of lipid-modifying lipids, including individuals considered to be statin intolerant, exposing to a high risk of cardiovascular events. More than 50% of ASCVD patients who can not achieve their LDL-C goals with statins alone require a reduction of less than 40% to reach their LDL-C level.
As a lipid management company, Esperion's mission is to provide once-a-day oral therapies, in addition to existing oral medications, to further reduce the LDL-C levels that these patients need.
The lipid management company
Esperion is the lipid management company that is pbadionate about developing and commercializing complementary, cost-effective, convenient, once-a-day oral therapies for the treatment of patients with high LDL-C. Through scientific and clinical excellence and in-depth knowledge of cholesterol biology, Esperion's experienced lipid management team is committed to developing new treatments that reduce LDL-C that will have a substantial impact on reducing cholesterol levels. cardiovascular diseases worldwide; the leading cause of death in the world. Biodedic acid and the Company's lead product candidate, the combination bempedic acid and ezetimibe tablets, are targeted therapies that have demonstrated a significant reduction in elevated LDL-C levels in patients with hypercholesterolemia. including in patients inadequately treated with current lipid modification treatments. For more information, visit www.esperion.com and follow us on Twitter at the address https://twitter.com/EsperionInc.
Forward-looking statement: Esperion
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including a statement regarding the regulatory approval process for the bempedohydroic acid / ezetimibe tablet and bempedic acid, as well as the therapeutic potential of this clinical development plan. with regard to the combination of bempedoic acid / ezetimibe and bempedoic acid, including timing, designs, plans and announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies on Bempedoic acid and the combination of Bempedoic Acid / Ezetimibe, Esperion's expectations regarding market treatments aimed at lowering LDL cholesterol, including the adoption in the market of Bempedoic acid and combination of biodedic acid / ezetimibe, if applicable, the expected milestones described in this press release and Esperion's cash position and financial outlook. Any express or implied statement contained in this press release that is not a statement of historical fact may be considered a forward-looking statement. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ materially from those projected, including, without limitation, delays or failures in Esperion's studies that Positive results from a clinical study on bempedoic acid may not be sufficient for the FDA or the approval of EMA or necessarily be predictive of the results of future or ongoing clinical studies. Regardless of the completion of Esperion's Phase 3 clinical development program for LDL-C reduction, the FDA or EMA may require further development as part of the ongoing application. regulatory approval, this EHR is able to successfully commercialize the bempedoic acid / ezetimibe tablet and bempedic acid, if approved, that existing cash resources can be used faster than anticipated and that the risks described in Esperion's filings with the Securities and Exchange Commission. Esperion disclaims any obligation or obligation to update or revise the forward-looking statements contained in this press release, except to the extent required by law.
References
1 Laufs U, et al. Efficacy and safety of bempédo acid in patients with hypercholesterolemia and intolerance to statins. JAHA 2019.
2 Preliminary results of the Phase 3 study on the combined bempedic acid and ezetimibe combination pill. Esperion investor. JAHA 2019 Presentation. August 27, 2018. Available at https://investor.esperion.com/static-files/1639de53-9494-4299-98a5-0b6f1317678a. Last access March 8, 2019.
3 Preliminary results of phase 3 of study 2 and cumulative results of the phase 3 program. Esperion Investor Presentation. October 29, 2018. Available at https://investor.esperion.com/static-files/32936da0-96f9-40e5-a12b-bd00ece6698d. Last access March 8, 2019.
4 Pinkosky L et al. Inhibition of ATP-specific citrate lyase of the liver by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nature. 2016: 10.1038.
5 Thompson PD, et al. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. J Clin Lipidol (2016) 10, 556-567.
6 Evaluation of major cardiovascular events in patients with statin intolerance and at high risk of acquiring cardiovascular disease with bempedic acid (ETC-1002) or placebo (CLEAR results). Available at https://clinicaltrials.gov/ct2/show/NCT02993406?term=bempedoic+acid&rank=4. Last access December 12, 2018.
Contact
Lydia Worms (Europe )
Daiichi Sankyo Europe GmbH
Communications and Public Relations Europe
+49 (89) 7808751
Investor contact
Alex Schwartz
Esperion
+ 1-734-249-3386
[email protected]
April 2019 BEM / 19/0001
SOURCE Daiichi Sankyo
Related Links
https://www.daiichisankyo.com/
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