Takeda Pharmaceutical Company Ltd recently announced positive results from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) study (n=5380) on its pipeline candidate, alogliptIn.
We note that alogliptIn, a dipeptidyl peptidase-4 inhibitor, is being developed for the treatment of adults suffering from type II diabetes to improve glycemic control as an adjunct to diet and exercise.
Takeda’s EXAMINE study is a global, large, randomized, double-blind, placebo-controlled clinical trial, evaluating cardiovascular (CV) safety in patients treated with alogliptIn plus standard of care in comparison to patients under placebo plus standard of care. The patients enrolled in the study were suffering both from type II diabetes and a recent acute coronary syndrome (ACS). The trial is being conducted under the U.S. Food and Drug Administration’s (FDA) 2008 guidance.
Results from the study revealed that the risk of CV did not increase in type II diabetes patients at high risk of major adverse cardiac events due to a recent ACS on using alogliptIn. There were no significant differences in rates of CV death, myocardial infarction, stroke and unstable angina with urgent revascularization in both the groups. Takeda also stated that both the alogliptIn and placebo groups had comparable rates of serious adverse events.
We note that the diabetes market currently looks extremely crowded with the presence of big companies like Eli Lilly and Company (LLY - Free Report) and Novo Nordisk (NVO - Free Report) .
Of late Takeda has progressed well with its pipeline. Last week Takeda and partner Zinfandel Pharmaceuticals, Inc. initiated a phase III study (TOMMORROW) on pioglitazone. The study is evaluating a genetic-based biomarker risk assignment algorithm (risk assignment algorithm) to detect the risk of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) within five years.
Takeda carries a Zacks Rank #3 (Hold). Currently, companies like Actelion Ltd. look well positioned in the pharma space with a Zacks Rank #1 (Strong Buy).