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Esperion (ESPR) Presents at JMP Conference & Spikes Up

15:31 EDT 21 Jun 2017 | Biotech Watcher

On Wednesday morning, June 21, CEO Tim Mayleben presented at the JMP Securities Life Science Conference. The company confirmed its milestones but especially its intent with the fixed dose combination program (bempedoic acid + ezetimibe).

This presentation dovetailed with the general valuation lift among biotechs, 

Mayleben announced that Esperion is on track to announce the fixed-dose combination (FDC) clinical program during the week of June 26. It is clear that Esperion wants to drive this program towards full commercialization.

Also, the triplet therapy program (FDC + Lipitor) should return results in Q3-2017, slightly ahead of schedule.

We will provide further commentary. You may wish to listen to the CEO's presentation - it is brief and Mayleben deftly touches on the current highlights.

For a review of Esperion's background, you may wish to consult our recent, general update.

Milestones

Esperion Therapeutics - Clinical Milestones
ETC – 1002 - Bempedoic acid
Bempedoic acid is an inhibitor of ATP citrate lyase (ACL). ACL is the primary enzyme responsible for the synthesis of cytosolic Acetyl-CoA in many tissues. The product, Acetyl-CoA, in animals serves several important biosynthetic pathways, including the metabolic formation of fat and cholesterol synthesis. Bempedoic acid inhibits cholesterol synthesis in the liver, decreases intracellular cholesterol and up-regulates LDL-receptors, resulting in increased Low Density Lipoprotein-Cholesterol (LDL-C) clearance and reduced plasma levels of LDL-C.
CLEAR Program – Establish LDL-Cholesterol Lowering via ETC-1002
CLEAR HARMONY - ETC - 1002-040– 2,233 pts.
A global Phase III randomized, multicenter, double-blind, placebo-controlled study evaluating 180 mg of bempedoic acid versus placebo in 2,233 patients with hyperlipidemia at high cardiovascular disease risk and whose LDL-C is not adequately controlled with maximally tolerated lipid-modifying therapy. The study finished enrolling patients from approximately 100 sites in the U.S., Canada and the European Union.

The primary objective is to assess safety and tolerability of patients treated with bempedoic acid for 52 weeks. Secondary objectives include assessing the effects of bempedoic acid on lipid and cardiometabolic risk markers, including LDL-C and hsCRP.
Top-line Results
Q2-2018
Open-Label, Extension Study (1002-050) Results -1,400 Pts
Q4-2019
Phase III efficacy and safety study of bempedoic acid in Patients with Hyperlipidemia and Statin Intolerance.
Top-line Results
Q3-2018
Phase III efficacy and safety study of bempedoic acid in Hypercholesterolemic Patients with ASCVDand/or HeFH. These are high cholesterol patients who are at risk for a cardio event and are not “Adequately Controlled with Current Lipid-Modifying Therapy” – this includes statin intolerant patients.
Top-line Results
Q3-2018
Phase III efficacy and safety study in Hypercholesterolemicpatients that are already taking ezetimibe. Subjects have elevated LDL-C not Adequately Controlled with Current Lipid Modifying Therapy
Top-line Results
Mid-2018
Study Completion
2H-2018
Establish Cardiovascular Risk Reduction
A Phase III trial of outcomes in statin intolerant patients. Esperion management requires a set number of patients to experience a MACE event (CD death, heart attack, stroke, hospitalization for angina, coronary artery bypass).
Anticipated Top-line Results
1H-2022
Additional Phase II Exploratory Studies
Esperion will conduct additional exploratory studies of bempedoic acid in combination with other drugs to (hopefully) broaden the label. This will potentially increase the palatability of Esperion and bempedoic acid for licensing and acquisition.   
Triplet Oral Therapy (1002-038) – bempedoic acid, atorvastatin (Lipitor), and ezetimibe. It’s the fixed dose combination tablet given with Lipitor “in the background”  – 60 pts.
Top-Line Results
Sept. 2017
Fixed Dose Combination (FDC) – 180 mg bempedoic acid + 10 mg ezetimibe (BA+EZ)
Phase II Program Announcement
Week of
June 26, 2017
Dual combination Therapy – bempedoic acid and PCSK9i
Program Announcement
2H-2017
Ex-USA Partnership
The extent of the (hoped for) partnership is unknown. There are several Big Pharma candidates that sorely need to reload or jumpstart its cardiovascular pipeline. While a partnership can be consummated in the near term, Esperion can afford to wait.
Announce Partnership
TBA
Regulatory Filings
Submissions for FDA / EMA Approval
New Drug Application (FDA) / Marketing Authorization Application (EMA) 
Indication: LDL-C lowering
1H-2019
New Drug Application (FDA) - Fixed-dose Combination Agent - BA+EZ
Indication:  LDL-C Lowering
2H-2019
New Drug Application (FDA) / Marketing Authorization Application (EMA) 
IndicationCardiovascular Risk Reduction
Q3-2022

(At the time this post was written, one or more BioWatch staff owned a long position in ESPR)

This blog post is from The Biotech Watcher

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