Washington Editor

Microbia Inc. raised a whopping $75 million in a private equity financing, the biggest single funding round this year.

"We’ve had a lot of interest in what our company has been doing," CEO Peter Hecht told BioWorld Today. He attributed that interest to the company’s fiscal efficiency in quickly creating "important new drug candidates."

Microbia’s portfolio, of course, is the primary beneficiary of this latest capital. The funds largely will be used to advance the clinical development of MD-1100 for chronic idiopathic constipation and MD-0727 for lowering LDL cholesterol. Both oral drug candidates have shown early potential in human studies, in terms of safety and efficacy.

The Cambridge, Mass.-based firm has raised $174 million in private equity financing since its 1999 inception. The latest marked its Series E round. Microbia’s lead drug, MD-1100, recently entered a second Phase II trial in the gastrointestinal disorder space. The study will assess its effects in patients with chronic idiopathic constipation, complementing an ongoing Phase II trial being conducted in those with constipation-predominant irritable bowel syndrome.

"In preclinical studies," Hecht said, "it has been shown to alleviate the two key, defining attributes of irritable bowel syndrome - chronic constipation and visceral pain."

Phase I data, to be presented later this year in a scientific forum, have shown MD-1100 to be well tolerated in healthy volunteers. "It has very limited exposure outside of the GI tract," Hecht said, "so it targets the site of action."

Also importantly, those findings show that it elicits gastrointestinal pharmacodynamic effects that would alleviate both conditions’ symptoms. Hecht added that the first-in-class molecule, which targets the guanylate cyclase C (GCC) receptor on the gastrointestinal luminal wall, might have utility in other gastrointestinal disorders, which the company will pursue down the road, but its initial focus remains with chronic idiopathic constipation and constipation-predominant irritable bowel syndrome.

Data from both dose-ranging Phase II trials will be available in the second half of this year.

Its other clinical compound, MD-0727, is in a second Phase I trial to test multiple doses of the next-generation cholesterol absorption inhibitor. Already, a single-dose trial has been completed in healthy volunteers. Preclinical testing has demonstrated its ability to reduce LDL cholesterol, and like MD-1100, its site of action is targeted inside the GI tract.

MD-0727 is being positioned to follow in the footsteps of Zetia (ezetimibe, from Schering-Plough Corp.) and Vytorin, a combination product that pairs Zetia with Zocor (simvastatin, from Merck & Co. Inc.). Hecht said those two products generate about $3 billion in annual sales these days, with more growth forecast ahead.

"There have been a very large number of clinical outcome studies showing that safely lowering LDL cholesterol has very beneficial effects on key outcomes [such as] heart attack, stroke and death," he said. "We believe we have the opportunity to have the best product for safely lowering LDL cholesterol."

Going forward, Hecht said Microbia would consider partnering these two compounds, given the right collaborative circumstances. Both, he noted, "have received a lot of interest from potential partners." But Hecht added that "our bias is to develop and commercialize the medicines that we create." The company owns all rights to MD-1100 and MD-0727.

Beyond both clinical programs, Microbia has a first-in-class product for asthma in late preclinical development. An oral compound, it could move into clinical studies next year. Also in its preclinical pipeline is an intravenous product for congestive heart failure.

All the company’s research and development efforts are partly supported by a cash-generating component of its business. Labeled its Precision Engineering unit, the division collaborates with pharmaceutical and chemical manufacturers to improve manufacturing efficiencies in existing fermentation processes or to create new bioprocesses.

The financing was led by Sigma Capital Management LLC, of New York, and joined by two additional New York firms, Jennison Associates LLC and Maverick Capital, as well as other investors. Existing backers also participated.