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OPKO Health, Inc. (NYSE:OPK), a multinational biopharmaceutical and diagnostics company, yesterday hosted a webcast presenting outstanding interim six-month results from a Phase 2 study of its long-acting human growth hormone product Lagova to treat pediatric growth hormone deficiency disorder (GHD).
During the webcast, Dr. Ron Rosenfeld, Chairman of OPKO Biologic’s Scientific Advisory Board and professor emeritus of Pediatrics at both Stanford University and Oregon Health and Science University, highlighted the superior interim results from the study. In particular, Dr. Rosenfeld, a pioneer in the recombinant human growth hormone field, noted that the mean height velocity achieved with each of the three different doses of Lagova administered in the study was “actually quite dramatic, ranging from 12.25 centimeters to almost 15.5 centimeters. Every child enrolled in the study experienced a significant improvement in height velocity from weekly administration of Lagova,” he noted.
“OPKO believes there is a significant market opportunity with Lagova, as compliance with daily injections is problematic. Non-compliance leads to a significant decrease in growth response in both adults and children, which is well evidenced by current clinical literature,” said OPKO’s CEO, Phillip Frost, M.D. “The outstanding interim Phase II results allow for dose selection for a Phase III study which is anticipated to start in 2015.”
Unlike other pediatric long-acting growth hormone deficiency clinical trials, the Lagova Phase II trials also included a direct comparator arm at the same population with similar baseline values. Children were given daily administration of growth hormone at a dosage of 0.24 mg/kg per week, but administered daily in a traditional manner. There was no statistically significant difference among any of the three dosage strengths of Lagova used in the study versus the comparator arm.
As any Phase III trial for a long-acting recombinant human growth hormone will likely require proof of non-inferiority against a comparator arm of daily administered growth hormone, this is an important distinction that gives OPKO great confidence in designing its non-inferiority pivotal Phase III study for Lagova. Had OPKO utilized historical database comparisons as utilized in other pediatric GHD clinical trials versus an actual comparator arm, annualized height velocity for Lagova at all three dosage strengths would have been notably superior, exceeding comparable age-matched historical controls, as published by Bakker (2008) and Ranke (2010) for the same GHD patient population by approximately 30%.