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.
“We look forward to updating you in the weeks ahead on our progress as we continue to rapidly advance ETC-1002 through the final stages of development for the treatment of patients with hyperlipidemia and mixed dyslipidemia,” Esperion president and CEO Tim M. Mayleben said.
Company highlights in recent weeks include:
• June 15: Dr. Mary McGowan appointed chief medical officer, and Dr. Scott Braunstein elected to the board of directors.
• July 7: Removal of the 240 mg partial clinical hold by the FDA, allowing ETC-1002 to be used at doses above 240 mg in clinical studies.
• July 28: Positive top-line Phase 2 results announced for ETC-1002-014 in patients with both hypercholesterolemia and hypertension.
• July 30: Second annual analyst and investor day.
The company said that in August it will hold an “end-of-phase-2” neeting with the U.S. Food and Drug Administration for ETC-1002 to discuss its planned Phase 3 tseting program. A webcast to announce and discuss results from the meeting will be held in the weeks that follow. And the company said it’s planning to initiate the Phase 3 clinical trial before the end of 2015.
In Phase 1 trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase 2 trials, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. And in Phase 3, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
The company, which does not yet have revenue, also provided financial results for the second quarter ended June 30.
The company posted a net loss of $12.4 million in the quarter, higher than $9.2 million in the second quarter of 2014. For the six months the loss was $23.9 million, worse than $17.1 million in the first half of 2014.
As of June 30, the company had cash and cash equivalents and investment securities available-for-sale of $314.3 million, up from $141.6 million as of Dec. 31.
Research and development expenses were $7.2 million for the second quarter of 2015 and $14.6 million for the six months ended June 30, compared to $6.5 million and $11.9 million for the comparable periods in 2014. The company said the increase in research and development expenses was largely driven by the further clinical development of ETC-1002.
General and administrative expenses were $5.3 million for the second quarter of 2015 and $9.3 million for the six months ended June 30, compared to $2.7 million and $5.2 million for the comparable periods in 2014. The company said increase in general and administrative expenses was primarily attributable to costs to support public company operations, increases in headcount, which includes increased stock-based compensation expense, and other costs to support Esperion’s growth.
Esperion expects that the net cash used to fund operating activities in 2015 will be approximately $42 million and that its cash and cash equivalents and investment securities available-for-sale will total approximately $290 million as of Dec. 31.
The Company estimates that current cash resources are sufficient to fund the Company through 2018 and the expected approval of ETC-1002.
To listen to a replay of a conference call discussing this announcement, visit http://investor.esperion.com.