PhaseBio Pharmaceuticals‘ phase I/IIa clinical study for its drug, Glymera, for the treatment of hyperglycemia in patients with type 2 diabetes, met with positive results, according to a release from the company.
The single and multiple ascending dose study of 80 subjects in three U.S. study centers assessed the safety, tolerability and pharmacokinetic or PK profile and evaluated peritoneal dialysis effects.
It demonstrated highly statistically significant reductions in fasting glucose glycemic load following meal tolerance testing, and average daily glucose measured through continuous glucose monitoring following four weeks of dosing, the release said.
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GLP-1 analogues that have been approved by the U.S. Food and Drug Administration need to be given at least once a day, said Lynne Georgopoulos, senior vice president of clinical development. “Our intent was to develop a long-acting drug that would provide full 24/7 coverage and we are extremely pleased to have such robust results this early in the development of Glymera that supports a weekly dosing regimen and plan to aggressively move Glymera through the development process,” at PhaseBio.
Hyperglycemia is a major cause of complications with diabetes, according to the American Diabetes Association. A report published by the International Diabetes Federation estimates that 1 in 10 adults will have diabetes, soaring to 552 million by 2030 unless steps are taken to change behavior and educate the public.
The Malvern, Pennsylvania clinical stage biopharmaceutical company focuses on endocrine, metabolic and cardiovascular disease. In addition to Glymera, it is also developing a treatment for chronic heart failure and hypertension called Vasomera, a vasoactive intestinal peptide, currently in preclinical development.
Among PhaseBio’s investors are New Enterprise Associates, Johnson & Johnson Development Corporation, Johnson & Johnson(NYSE: JNJ), the drug company’s venture capital subsidiary, Hatteras Venture Partners, Astellas Venture Management— the corporate venture arm of Japan-based Astellas Pharma — and Fletcher Spaght Ventures.
