InteKrin Therapeutics Presented Phase 2b Clinical Data at the 2010 American Diabetes Association Annual Meeting, Demonstrating Improved Glycemic Control in Patients with Type 2 Diabetes Without Causing the Edema Seen with Pioglitazone
LOS ALTOS, Calif., June 29 /PRNewswire/ -- InteKrin Therapeutics
presented 6 month Phase 2b clinical data for edema in diabetic
patients showing differentiation for INT131, a Selective PPAR-gamma
Modulator (SPPARM), from Actos® (pioglitazone), yesterday at
the American Diabetes Association annual meeting in Orlando,
INT131 besylate (INT131) is a novel, non-TZD, selective oral
PPAR-gamma modulator (SPPARM) designed to improve glucose
metabolism while minimizing the side effects of the TZD full
PPAR-gamma agonists such as Actos®: fluid retention (edema),
CHF, bone fracture, and weight gain. The Phase 2b trial,
INT131-007, was a 366 patient 24 wk double blind study comparing 4
doses of INT131 to maximal dose Actos® (pioglitazone) or
placebo in patients with poorly controlled T2DM on stable dose
sulfonylurea (SU) with or without metformin (met). Lower extremity
edema was assessed with a predefined scoring tool designed for
maximal sensitivity for pitting edema at baseline, 12, and 24 wks.
Results show INT131 improved glycemic control as measured by HbA1c
comparable to Actos® but without evidence of any significant
change in edema compared to baseline or placebo. Substantial edema
was noted in the pioglitazone group, consistent with published
data. These findings support the SPPARM function of INT131 and
suggest it represents a safer insulin sensitizer.
"This data clearly differentiates INT131 besylate from
pioglitazone with respect to the important clinical parameter of
edema," remarked Dr. Alex DePaoli, Acting Chief Medical Officer of
InteKrin Therapeutics, who presented the data. "These findings are
consistent with previous clinical data and support the advantages
of the SPPARM nature of this agent."
"Insulin sensitization is a core therapeutic mechanism for
addressing the Type 2 Diabetes epidemic," added Dr. Linda Higgins,
President & Chief Operating Officer of InteKrin Therapeutics.
"INT131 besylate offers a potential significant advance in
addressing the critical need for a safe insulin sensitizer."
INT131 is a next-generation insulin sensitizer that addresses
insulin resistance, a key etiological feature in the onset and
subsequent progression of Type 2 Diabetes. As a selective
PPAR-gamma modulator (SPPARM), INT131 has been designed to provide
potent glucose lowering and durability of effect without the
recognized side effects of the currently available insulin
sensitizers which, unlike INT131, are full PPAR-gamma agonists.
InteKrin has completed an End-Of-Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) for INT131 and is moving the program
into Phase 3 development.
About InteKrin (www.InteKrin.com)
InteKrin Therapeutics is a privately-held clinical-stage drug
development company focused on diabetes, obesity and metabolic
disease. InteKrin's business strategy is to build a robust
portfolio of high value products by in-licensing clinical-stage
therapeutic candidates that address significant unmet medical needs
and rapidly move them through critical development stages.
InteKrin's team of world-class scientific and medical experts
includes veterans from several successful BioPharma organizations,
internationally recognized experts in nuclear receptors and
metabolism, top scientists formerly with the Food and Drug
Administration and key clinical and commercialization
To learn more about InteKrin, visit www.InteKrin.com.
Source: InteKrin Therapeutics
CONTACT: Heather Zimmerman, InteKrin Therapeutics Inc.,
Posted: June 2010