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news.Metabasis Therapeutics, a biopharmaceutical company, has reported positive results from a clinical trial in which MB07803 was administered twice-daily for 14 days to patients with poorly controlled type 2 diabetes.
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According to Metabasis, MB07803 treatment resulted in dose-related, clinically meaningful and statistically significant reductions in day long glycemia (24-hour weighted mean glucose levels) at all doses evaluated (50mg, 200mg and 400mg, twice-daily).
In addition, clinically and statistically significant reductions in fasting plasma glucose (FPG) were observed at the two highest doses. MB07803 was considered safe at all doses tested and well tolerated up to 200mg twice-daily, the company said.
MB07803 is Metabasis’s second-generation product candidate from a new class of drugs that the company discovered internally for the treatment of type 2 diabetes. The clinical trial was designed to investigate whether administration of the newly developed MB07803 tablet formulation twice-daily would increase drug concentrations and whether higher drug concentrations would be safe and well-tolerated and result in better glucose lowering compared to placebo.
Approximately 42 poorly-controlled type 2 diabetes mellitus patients diagnosed for an average duration of 7.3 years, with a mean baseline FPG of 221 mg/dL and mean baseline HbA1c of 8.8% were enrolled in a 14-day, randomized, double-blind, placebo-controlled, domiciled, ascending multiple dose clinical trial. Patients received either an oral dose of 50mg, 200mg, or 400mg MB07803 or a matching oral dose of placebo every 12 hours.
Mark Erion, president, CEO and chief scientific officer, said: “These results clearly establish FBPase as a drug target capable of significant glucose lowering in patients with poorly controlled type 2 diabetes. We believe that MB07803 could be used to effectively treat patients who cannot take metformin and therefore must take drugs that are either less efficacious or associated with a suboptimal safety profile.
“Patients who are poorly controlled with current therapies and must consider injectable therapies such as insulin and GLP-mimetics may also be potential candidates given that MB07803 achieves significant glucose lowering throughout the day as an oral therapy.”