InteKrin Therapeutics Announces INT131 Phase 2a Results at the 2009 American Diabetes Association Annu...( LOS ALTOS Calif. June 10 /- InteKrin ...),Health

LOS ALTOS, Calif., June 10 /PRNewswire/ -- InteKrin Therapeutics Inc presented Phase 2a clinical study results at the American Diabetes Association annual meeting in New Orleans demonstrating that once a day oral treatment with INT131 provides anti-diabetic efficacy consistent with maximal dose thiazolidinedione (TZD) therapy but with less hematocrit reduction and weight gain.

The 4 week double blind placebo controlled study of INT131 in Type 2 Diabetes Mellitus (T2DM) patients previously not on pharmacological therapy showed a dose dependent decrease in fasting plasma glucose (FPG) at 4 weeks, the primary endpoint of the study. This decrease was already statistically significant at 1 week for both low and high doses (1 mg and 10 mg) of INT131.

The efficacy measured at 4 weeks of 1 mg of INT131 treatment was comparable to the efficacy modeled for this patient population treated with the maximal approved doses of Actos(R) and Avandia(R), but in contrast the low dose INT131 group did not show the significant weight gain or fluid retention (measured by hematocrit drop) modeled for maximal dose TZDs. The high dose INT131 group showed about twice the decrease in FPG attained with low dose INT131, and a correspondingly greater efficacy compared to that modeled for maximal dose TZDs. Importantly, this greater efficacy was achieved with INT131 without greater weight gain or hematocrit drop than expected for maximal dose TZDs. INT131 was well tolerated in this study with no safety issues noted.

"These data are supportive of INT131 acting as a selective modulator of PPARgamma in T2DM patients," remarked Dr Alex DePaoli, Chief Medical Officer of InteKrin Therapeutics, who presented the data. "The key observation from this study is that INT131 is a potent insulin sensitizer that lowers fasting glucose as well as the maximal dose of the TZDs while mitigating the typical side effect profile."

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