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InteKrin Therapeutics Announces Initiation Of Phase 2b Study In Type 2 Diabetes With INT131
InteKrin Therapeutics, Inc.,
a privately-held clinical stage biopharmaceutical company focused on the
development and commercialization of novel drugs for the treatment of
diabetes, obesity and metabolic disease, announced that it has
initiated a Phase 2b study in diabetic patients with its lead product
candidate INT131, a non-TZD SPPARM (Selective Peroxisome
Proliferator-Activated Receptor Modulator). INT131 was the result of an
extensive molecular design effort to address the product profile
deficiencies of current TZD therapy, which while efficacious present
problematic safety concerns. INT131 was selected specifically for its
ability to reduce characteristic TZD adverse effects while retaining
powerful PPAR anti-diabetic efficacy. This placebo controlled,
double-blind, Phase 2b study includes multiple doses of orally administered
INT131 once daily, and Actos(R) (pioglitazone) as an active comparator.
"INT131 has consistently demonstrated potent and selective PPAR-gamma
modulation through each phase of development including recently completed
primate safety studies, wherein an absence of recognized TZD adverse
effects such as edema offers a genuine breakthrough for this target," said
Linda Slanec Higgins, PhD, InteKrin's Chief Scientific Officer.
"Preclinical safety multiples with INT131 are far greater than those seen
with the currently marketed, first generation TZD full agonists."
"From a clinical perspective, insulin resistance is a key etiological
feature in the onset and subsequent progression of Type 2 Diabetes, and it
remains inadequately addressed by current therapies. INT131 has been
demonstrated to be a potent and efficacious insulin sensitizer in humans
and offers the opportunity for disease modification without the edema and
weight gain of current TZD therapies," said Alex DePaoli, MD, InteKrin's
Chief Medical Officer. "The initiation of this robust Phase 2b study
represents an important milestone in bringing a novel, breakthrough
therapeutic to patients which is complementary to other treatment
modalities."
"There is a significant product profile gap in treating and improving
insulin sensitivity in diabetic patients as a result of safety deficiencies
with existing TZD therapy. INT131 is ideally positioned to potentially
fulfill an unmet medical need for patients," said Denny Lanfear, InteKrin's
President and CEO. "This study represents an important step in our overall
global product development plan."
About InteKrin
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 leaders.
To learn more about InteKrin, visit http://www.InteKrin.com.
InteKrin Therapeutics, Inc.
http://www.InteKrin.com
View drug information on ACTOS.
InteKrin therapeutics anunþã iniþierea 2b faza de studiu în diabet zaharat de tip 2 cu INT131 - InteKrin Therapeutics Announces Initiation Of Phase 2b Study In Type 2 Diabetes With INT131 - articole medicale engleza - startsanatate