Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genaera, a biopharmaceutical company, has reported promising preliminary Phase Ib clinical data for trodusquemine, the highly selective inhibitor of PTP1B and the company's lead drug candidate for the treatment of type 2 diabetes and obesity.
Subscribe to our email newsletter
The company has reported data from the first of three cohorts in an ascending multiple dose study of MSI-1436 (Study 102). Data from cohort 1, in which eight doses of 3mg/m2 of MSI-1436 were administered over 21 days to overweight and obese type 2 diabetic subjects, demonstrated meaningful improvement in four primary outcomes used to evaluate type 2 diabetes.
The data demonstrated a 9.5% decrease in fasting blood glucose with a resulting 17% differential compared to placebo subjects in the same cohort, a 7% decrease in the area under the curve during the oral glucose tolerance test; an 11.3% decrease in serum fructosamine, which is used to monitor short-term (two to three weeks) blood sugar control; and a 0.4% decrease in hemoglobin A1C (HbA1C), used to monitor longer-term (two to three months) blood sugar control.
In cohort 1 of study 102, five subjects received MSI-1436 while two subjects received placebo, with results suggesting that MSI-1436 is well-tolerated, with no serious adverse events, no severe adverse events and no dose-limiting toxicities reported, the company said.
Jack Armstrong, president and CEO of Genaera, said: MSI-1436 continues to exhibit promise as the only PTP1B inhibitor in development to simultaneously treat both type 2 diabetes and obesity. Our recent identification of a novel binding site we believe is the key to its selectivity and safety to date. We are anxious to begin our first study of subcutaneously administered MSI-1436 to human subjects, which is planned for later 2009.