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OPKO Reports Additional Oxyntomodulin, OPK-88003, Results From Phase 2 Diabetes and Obesity Trial
MIAMI, April 12, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today reported additional results from the per protocol patient population from the
About this update from Opko Health, Inc.
[{"type":"text","content":"MIAMI, April 12, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today reported additional results from the per protocol patient population from the Phase 2 dose escalation trial of OPK-88003 to treat type 2 diabetes and obesity.Topline data were previously reported on March 21, 2019 for the modified intent to treat (mITT) patient population using the mixed model repeated measures (MMRM). The mITT population included all patients that received at least one dose of drug and had one post-baseline evaluation. In the mITT population OPK-88003 showed a strong, clinically meaningful reduction in HbA1c at 30 weeks of -1.30% in the treated group from baseline (p-value Analysis of HbA1c and Body Weight Changes from Baseline to Week 30Following further analyses in the per protocol population, which includes all patients that received treatment with OPK-88003 for at least 26 weeks of the 30-week trial, the decrease in HbA1c and the increase in weight loss were more pronounced compared to the mITT patient population. The reduction in HbA1c at 30 weeks was -1.47% (p-value Similarly, other efficacy parameters improved in the per protocol population such as percentage of patients achieving less than 6.5% HbA1c, percentage of patients achieving weight loss greater than 5% and decrease in serum level of triglycerides.This Phase 2b trial evaluated the effects of a dose-escalation regimen of OPK-88003 on HbA1c, weight loss and safety over 30 weeks in adult type 2 diabetes patients with inadequate glucose control with metformin and/or diet and exercise. A total of 113 type 2 diabetics were enrolled and randomized into two arms; OPK-88003 and placebo, at a ratio of 1.75:1. The trial included a volume-matched placebo arm and an OPK-88003 treated arm, starting with 20 mg for 4 weeks, then 40 mg for 4 weeks, and finally, a target dose of 70 mg for 22 weeks.The Phase 2b dose escalation trial demonstrated that the once weekly OPK-88003 provided competitive clinical data. OPKO is planning to further evaluate OPK-88003 in a Phase 3 clinical program in type 2 diabetes and obesity, as well as in other promising indications such as NASH.About OPKO Health, Inc.OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation's third largest clinical laboratory; GeneDx is a rapidly growing genetic testing busin...