ANN ARBOR — The cholesterol-fighting drug developer Esperion Therapeutics Inc. (NASDAQ:ESPR) Tuesday announced the proposed sale of $150 million of its common stock in an underwritten public offering.
Esperion also expects to grant the underwriters a 30-day option to purchase up to $22.5 million of additional shares of its common stock.
Continue reading Esperion Announces Public Offering of Common Stock
ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ:ESPR), the Ann Arbor-based pharmaceutical startup, announced the initiation of a Phase 2 clinical study (1002-039) to assess the efficacy and safety of its drug candidate, bempedoic acid, in addition to another form of injectable cholesterol-fighter.
Continue reading Esperion Sets Phase 2 Study Of Cholesterol Buster Combo
ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ:ESPR), the pharmaceutical startup working on a new class of cholesterol-reducing drugs, provided a drug development update and financial results for 2016.
Continue reading Esperion Provides Drug Development Update, Financial Results
ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq: ESPR) reported completing enrollment of a new Phase 3 study of about 2,000 patients testing its drug candidate bempedoic acid to treat high cholesterol.
The trial will test the drug’s safety and tolerability in treating patients at high risk of cardiovascular disease whose low-density lipopritein-C, the so-called bad cholesterol, is not adequately controlled with current lipid-modifying therapies.
Top-line results from this study are expected by June 2018.
Continue reading Esperion Completes Enrollment In Trial Of Cholesterol-Buster
ANN ARBOR — Esperion Therapeutics Inc. (Nasdaq: ESPR), the Ann Arbor pharmaceutical startup working on a new class of cholesterol-cutting drugs, said it lost $17.4 million or 77 cents a share in the third quarter ended Sept. 30, vs. a loss of $12.8 million or 57 cents a share in the year-earlier period.
The company does not yet have revenue.
For the nine months, the loss was $46 million or $2.04 a share, compared to $36.7 million or $1.68 a share in the first nine months of 2015.
Last month, the company reported positive results in its Phase 1 and Phase 2 clinical studies of its lead drug candidate, bempedoic acid (ETC-1002), in combination iwth high-dose statins. It also amended and expanded a Phase 3 study to include 1,950 patients.
Continue reading Esperion Provides Financial, Research Update
ANN ARBOR — The cholesterol-busting drug developer Esperion Therapeutics Inc. (NASDAQ:ESPR) said its Phase 3 clinical trial of drug candidate bempedoic acid will include patients with high cholesterol who are already taking any and all statin drugs.
The move comes based on positive results from Phase 2 trials adding bempedoic acid to patients already taking the statin drug atorvastatin. Adding bempedoic acid lowered cholesterol a further 22 percent compared to placebo. It also demonstrated an incremental reduction of 35 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease. Bempedoic acid also appeared to be safe and well-tolerated, with no serious adverse events reported.
Continue reading Esperion Sets Broader Trial For New Cholesterol-Fighter
ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ: ESPR) has outlined its plans for Phase 3 clinical trials of its lead product candidate, ETC-1002, after receiving minutes of its end of Phase 2 trials meeting with the U.S. Food and Drug Admniistration.
Esperion says it plans multiple Phase 3 clinical trials that will include patients who can’t use today’s statin drugs to reduce the levels of low-density lipoprotein, the so-called bad cholesterol, or whose cholesterol levels don’t respond adequately to today’s statin drugs.
Continue reading Esperion Outlines Plans For Phase 3 Tests Of Cholesterol Drug
ANN ARBOR — The pharmaceutical startup Esperion Therapeutics Inc. (NASDAQ: ESPR) said it’s moving toward Phase 3 clinical testing of its leading drug candidate, ETC-1002, or bempedoic acid.
In Phase 1 and Phase 2 testing, ETC-1002 has been shown to reduce levels of low-density lipoprotein, the so-called bad cholesterol, and other markers of cardivascular stress — without side effects such as muscle pain and weakness that some people experience with today’s statin drugs.
Continue reading Esperion Moving Ahead With Cholesterol-Buster
ANN ARBOR — The Ann Arbor pharmaceutical developer Esperion Therapeutics Inc. (NASDAQ: ESPR) Tuesday announced positive results from a Phase 2 study evaluating the safety and effectiveness of its lead candidate for cholesterol reduction, ETC-1002.
The company says the six-week study of 142 test subjects met its primary goal of reducing low-density lipoprotein, the so-called bad cholesterol, by 21 percent from the starting point, and a 24 percent reduction compared to patients treated with a placebo, which the company called “statistically significant and clinically meaningful.”
The company said the reduction occurred within the first two weeks of initiating therapy and continued throughout the treatment period.
The test also showed a 25 percent from baseline and 44 percent vs. placebo reduction in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease.
The company also said ETC-1002 produced a neutral effect on blood pressure, appeared to be safe and well-tolerated and produced no muscle-related adverse events.
“This exploratory study is another important milestone in the development of ETC-1002, demonstrating its ability to safely lower LDL-cholesterol in a group of patients with both hypercholesterolemia and hypertension,” said Tim M. Mayleben, Esperion president and CEO. “We are pleased with these results, and with the whole of our phase two program, which continues to demonstrate the potential for ETC-1002 to provide an effective once-daily, oral treatment option for a broad range of patients with hypercholesterolemia.”
The test was designed to measure ETC-1002’s ability to reduce cholesterol in patients with high cholesterol and high blood pressure. The company said ETC-1002 has demonstrated consistent LDL-cholesterol reduction throughout its Phase 2 development program:
More at http://www.esperion.com.
ANN ARBOR — Esperion Therapeutics Inc. (NASDAQ: ESPR), a pharmaceutical company focused on oral cholesterol-lowering therapies, announced the U.S. Food and Drug Administration has removed the 240 mg partial clinical hold on its drug candidate ETC-1002, bempedoic acid.
This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.
Continue reading FDA Allows Higher Doses Of Esperion Cholesterol Drug