11 Feb 2009 04:00 AM
Genaera Presents Preliminary Phase 1b Data For Trodusquemine (MSI-1436)
Genaera Corporation (Nasdaq: GENR) reported promising preliminary Phase 1b clinical data for trodusquemine (MSI-1436), the first-in-class, highly selective inhibitor of PTP1B and Genaera's lead drug candidate for the treatment of type 2 diabetes and obesity. Mr. Jack Armstrong, President and CEO of Genaera, presented data from the first of three cohorts in an ascending multiple dose study of MSI-1436 (Study 102), during the BIO CEO & Investor Conference in New York.
Data from cohort 1, in which eight doses of 3 mg/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, including:
-- 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 (2-3 weeks) blood sugar control; and
-- A 0.4% decrease in hemoglobin A1C (HbA1C), used to monitor longer-term (2-3 months) blood sugar control.
"It is very exciting to see a believable biologic response to MSI-1436 in cohort 1 of Study 102. While 3 mg/m2 of drug was thought to be a sub-therapeutic dose, the data has demonstrated otherwise. We are currently completing the in-house portion of the second cohort of this study evaluating 6 mg/m2 of MSI-1436 and the initial results support proceeding to the 10 mg/m2 cohort which will begin later this month. Final Study 102 data is expected in the second quarter," commented Mr…
Data from cohort 1, in which eight doses of 3 mg/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, including:
-- 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 (2-3 weeks) blood sugar control; and
-- A 0.4% decrease in hemoglobin A1C (HbA1C), used to monitor longer-term (2-3 months) blood sugar control.
"It is very exciting to see a believable biologic response to MSI-1436 in cohort 1 of Study 102. While 3 mg/m2 of drug was thought to be a sub-therapeutic dose, the data has demonstrated otherwise. We are currently completing the in-house portion of the second cohort of this study evaluating 6 mg/m2 of MSI-1436 and the initial results support proceeding to the 10 mg/m2 cohort which will begin later this month. Final Study 102 data is expected in the second quarter," commented Mr…

