OPKO Health update on hGH-CTP program fails to please investors
US drugmaker OPKO Health (Nasdaq: OPK) saw its shares fall 18.6% to $9.30 by mid-morning trading on Friday, after it announced that a Phase III trial of a human growth hormone product (hGH-CTP) failed to meet its main goal, but said multiple outliers may have affected the result.
On the primary endpoint of change in trunk fat mass from baseline to 26 weeks, there was no statistical difference between hGH-CTP and placebo in adults with growth hormone deficiency (GHD). However, after unblinding the study, OPKO identified one or more outliers that may have affected the primary outcome.
As a result, OPKO is undertaking further review of the study population as promptly as possible. The safety profile observed in this study was consistent with that known for growth hormone treatments. A greater percentage of subjects on hGH-CTP normalized serum concentrations of insulin-like growth factor-I compared to placebo. Additional efficacy and safety data and analyses from the study will be released once available.
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