OPKO Announces Positive Topline Results In Phase 2 Diabetes And Obesity Trial

OPKO Health (NASDAQ:OPK) has announced positive topline results from a Phase 2 dose escalation trial for OPK88003 to treat type 2 diabetes and obesity.

As quoted in the press release:

Based on data from a previous 420 patient Phase 2 study, an optimized dosing regimen for OPK88003 was evaluated to improve glucose control and increase weight loss.  Topline analysis of results of the study demonstrated that OPK88003 met the primary objective with a statistically significant lowering of hemoglobin A1c (HbA1c) after 30 weeks of treatment versus placebo as well as an important secondary endpoint, statistically significant weight loss versus placebo.

This Phase 2b trial evaluated the effects of a dose escalation regimen of OPK88003 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.  One hundred and thirteen type 2 diabetes patients were enrolled and randomized into two arms, OPK88003 or placebo, at a ratio of 1.75:1, with a volume matched placebo arm and an OPK88003 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 data were analyzed for the modified intent to treat patient population (mITT; 108 of 113 patients) using the mixed model repeated measures (MMRM).  The mITT population includes all patients that received at least one dose of drug and had one post baseline evaluation.

OPK88003 showed a strong, clinically meaningful reduction in HbA1c at 30 weeks (-1.30% versus placebo, -0.09% mean absolute reduction, p<0.0001). Additionally, 50% of OPK88003 treated patients achieved HbA1c ≤6.5% versus 13.8% of placebo treated subjects (p=0.0008).

Patients treated with OPK88003 achieved a significant weight loss at 30 weeks (-4.4 kg, compared to placebo -1.8 kg, p=0.01).  Approximately 38% of treated patients achieved a 5% or greater body weight loss compared to 13% of placebo treated patients (p=0.008).

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