Venture capitalists are funneling money into biotech start-ups with approaches to treating Type 2 diabetes that may enable them to sidestep problems seen in existing medicines.
Two leading Type 2 diabetes medicines, Takeda Pharmaceutical’s Actos and GlaxoSmithKline’s Avandia, now carry warnings that they cause or worsen congestive heart failure in some patients. In September, the Food and Drug Administration restricted Avandia use because of evidence suggesting an elevated risk of cardiovascular problems, such as heart attack and stroke, in patients taking the drug.
Concerns about these products are creating even more demand for new ways to treat Type 2 diabetes, which accounts for 90%, or more, of diabetes cases. Some 23.6 million Americans have diabetes, according to the American Diabetes Association. By 2020, more than half of U.S. adults could have diabetes or pre-diabetes, according to an analysis issued last month by UnitedHealth Group’s Center for Health Reform and Modernization.
The safety risks that have surfaced with some of today’s drugs are prompting regulators to examine new Type 2 diabetes medicines even more closely. The disease’s complexity and the regulatory scrutiny are daunting to some venture investors, but several now see enough promise in new technologies coming along to jump in anyway.
In April, Advanced Technology Ventures, Clarus Ventures, MedImmune Ventures and SV Life Sciences committed $39.6 million in first-round financing to Catabasis Pharmaceuticals Inc., of Cambridge, Mass., which aims to harness the new understanding of the role inflammation plays in Type 2 diabetes to treat the disease. The company plans to begin testing its first diabetes drug in humans in the second half of next year.
“Type 2 diabetes was on our ‘don’t fly’ list before we invested in Catabasis,” said SV Life Sciences Managing Partner Michael Ross. “It took a [lot] of diligence for us to get comfortable with this investment.”
Other small companies are developing new means of achieving the same benefits of Actos and Avandia, which treat the insulin resistance that is a hallmark of Type 2 diabetes. Metabolic Solutions Development Co., which secured $23.5 million in venture funding in September, seeks to improve insulin sensitivity through drugs that selectively target a new mitochondrial target.
Because its drugs do not affect peroxisome proliferator-activated gamma receptors, as Actos and Avandia do, the company does not expect them to cause weight gain and other side effects seen in those marketed products, according to Stephen Benoit, chief executive of the Kalamazoo, Mich.., company. Its backers include Hopen Life Sciences and Southwest Michigan First Life Sciences Fund.
Some start-ups seek to improve upon ideas first advanced by larger companies. PhaseBio Pharmaceuticals Inc., of Malvern, Pa., recently completed a $25 million venture round led by New Enterprise Associates to test a drug what it hopes will be a better version of Bydureon, a product being developed by Amylin Pharmaceuticals Inc., Alkermes Inc. and Eli Lilly & Co.
Bydureon, which is not yet approved for sale, is a once-weekly version of a marketed drug, Byetta, which is injected twice daily. Yet both can cause nausea because patients get a burst of the drug initially. PhaseBio’s drug, Glymera, is designed to remain at a steady, consistent level in the bloodstream, a key reason that nausea is not expected to be a problem, according to CEO Christopher Prior.
Each of these companies has much work to do before its product will be ready for pharmacy shelves, however, and unforeseen problems could crop up in any of these new drugs. Showing promise in clinical trials is no guarantee of success, either. Venture-backed Phenomix Corp. recently shut down after partner Forest Laboratories Inc., citing business reasons, terminated a deal to develop the company’s Type 2 diabetes medicine.
Phenomix’s drug met its goals in the first of six Phase III clinical trials, but the drug would have faced competition from similar products such as Merck & Co.’s Januvia, which is already on the market.
http://blogs.wsj.com/venturecapital/2010/12/14/searching-for-a-new-way-to-treat-type-2-diabetes/tab/print/
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