A biotechnology company developing a long-acting drug for hyperglycemia associated with type 2 diabetes has initiated a multisite Phase 2b trial, according to a company statement.
PhaseBio Pharmaceuticals‘ lead drug Glymera is a recombinant glucagon-like peptide injected subcutaneously. Earlier this year, Christopher Prior, PhaseBio CEO, told MedCity News the results of Glymera’s phase 1 clinical trial were so compelling that it planned to compare it with the current gold standard treatment, Victoza — a once-daily treatment produced by Danish pharmaceutical company Novo Nordisk, which has its U.S. headquarters in Princeton, New Jersey.
The phase 2b trial will include 600 patients with type 2 diabetes inadequately controlled with diet and exercise, metformin, a sulfonylurea or a combination of metformin/sulfonylurea, according to the statement. It will evaluate the efficacy and safety of three doses of once-weekly Glymera compared to a matched placebo as well as comparator, presumably Victoza. This study is set to be completed by the second half of next year.
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The biotechnology firm raised $48.4 million earlier this year in its third tranche for its series B financing round led by New Enterprise Associates with participation by Hatteras Venture Partners, Johnson & Johnson Development Corp., Astellas Venture Management and Fletcher Spaght Ventures.
The drug is injected subcutaneously. Because it is absorbed slowly in the body, it can drastically reduce or eliminate the effects of nausea that similar drugs in the class have, according to Prior. The drug’s technology makes it more cost effective to produce, making it more likely to be reimbursed by payers. The company is also exploring its use to reduce obesity in people with type 2 diabetes.
About 25.8 million people have diabetes in the U.S. in 2010, according to stats from the National Institutes of Health, including an estimated 7 million who have not yet been diagnosed. The global annual market for products in the management of diabetes is estimated to be $41 billion according to MedMarket Diligence.