Opko Health (OPK) shares are up by over 3% in pre-market trade Friday on new data from the phase 2 dose escalation trial of OPK-88003 to treat type 2 diabetes and obesity.
The company initially unveiled topline data in March for the modified intent to treat (mITT) patient population using the mixed model repeated measures (MMRM). In the mITT population, which included all patients that received at least one dose of drug and had one post-baseline evaluation, OPK-88003 showed a strong, clinically meaningful reduction in HbA1c at 30 weeks.
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Following 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 with the mITT patient population.
It was found that OPK-88003 treatment was more effective in patients who received the drug for at least 26 weeks and were compliant with the protocol for the duration of the trial.
The phase 2b dose escalation trial showed that the once weekly OPK-88003 provided competitive clinical data.
As a result, Opko said it 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 nonalcoholic steatohepatitis (NASH).
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