Microbia Inc. raised $50 million in private equity to push product development, with a particular focus on multiple Phase II studies of its two lead products.
"The capital is essentially all going to be invested in our therapeutics product pipeline," CEO Peter Hecht told BioWorld Today, adding that the new money "comfortably funds us" through the completion of all planned Phase II testing "and gives us multiple strategic options around financing and partnering beyond that."
Specifically, the lion's share is tabbed for linaclotide, a drug for functional gastrointestinal disorders, and MD-0727, a compound for hypercholesterolemia. Additionally, the Cambridge, Mass.-based company plans to direct a portion of the funds for other undisclosed products in its pipeline that have moved beyond early discovery stages.
Since its 1998 founding, Microbia has raised $231 million in six rounds of private equity financing, a backing indicative of its investors' high hopes for its potential entries into large markets with the orally available small molecules, not to mention their lack of commonality, Hecht said, calling them "completely uncorrelated risks."
New drugs for various forms of irritable bowel syndrome and high cholesterol could be used by many millions of people, because existing therapies in both areas "leave room for a lot of improvement," he added. In contrast, Microbia's clinical compounds "are largely restricted" to their required sites of action in the gastrointestinal tract, Hecht said, "so we've been able to innovate on safety as well as efficacy."
Patient enrollment is under way in a dose-ranging study to investigate linaclotide's safety and efficacy in patients with chronic constipation, and a second dose-ranging trial in a slightly different indication, constipation-predominant IBS, is scheduled to begin later this month. Together, the two studies will enroll more than 700 patients.
Past clinical testing of linaclotide, a first-in-class guanylate cyclase-C agonist formerly called MD-1100, demonstrated its ability to improve symptoms of chronic constipation and constipation-predominant IBS. Preclinical models have shown the peptide's ability to improve gastrointestinal transit and secretion and alleviate visceral pain.
The only approved drug for constipation-predominant IBS is Zelnorm (tegaserod, Novartis AG), which generated more than $500 million in sales last year, Hecht said, but works through "a completely different mechanism" than linaclotide. The former and others like it act on serotonin, while the latter works within the gastrointestinal wall and also could find use in other gastrointestinal disorders such as opioid bowel dysfunction and opioid-induced constipation, but they're to be pursued down the road.
Data from the linaclotide studies, which are measuring stool frequency as primary endpoints, are expected in the second half of this year.
Additionally, Microbia is enrolling an undisclosed number of high cholesterol patients in a dose-ranging study of MD-0727's safety and efficacy in lowering LDL cholesterol over 28 days, the trial's primary endpoint. Data also are expected in the second half of this year.
Preclinical evaluations of the drug, a cholesterol absorption inhibitor, have shown that it acts in the lumen of the intestine and exhibits minimal systemic exposure, which would fill a need that existing therapies don't achieve.
"Outcome studies show over and over that lowering cholesterol effectively reduces mortality and morbidity," Hecht said. "The need for better therapies to get patients safely to goal is a very high priority for physicians and patients."
MD-0727 is expected to be used in addition to statin therapies to potentially achieve greater cholesterol control at lower statin doses. It's being positioned to follow in the footsteps of a pair of blockbusters, Zetia (ezetimibe, Schering-Plough Corp.) and Vytorin, a combination product that pairs Zetia with Zocor (simvastatin, Merck & Co. Inc.).
Microbia owns all rights to both linaclotide and MD-0727; both arose from its labs. With a hopeful eye toward their commercialization, Hecht said it remains the company's intention to create, develop and market its medicines, a preference to retain risks and rewards, though there is not an absolute aversion to partnerships.
For some drugs, "we will develop and commercialize ourselves," he said, while in other cases, partners will be enlisted to "bring us capabilities we don't have ourselves yet and where it would be more challenging to access those [markets] quickly."
The financing was led by Ridgeback Capital, a New York firm that was joined by a new investor, Morgan Stanley Investment Management in New York, as well as existing investors. Microbia last raised money a year ago, bringing in $75 million in its Series E round. (See BioWorld Today, Feb. 28, 2006.)