OPKO Health, Inc. 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%.
Lagova uses OPKO Biologics' novel CTP technology which attaches a short
naturally occurring peptide to the natural human growth hormone. Approximately
75% of the injected protein in Lagova is the actual native growth hormone,
altogether resulting in a highly water soluble compound that can be delivered
in high concentrations using a very thin 31 gauge needle to patients of a wide
range of body weights and ages by a single, weekly injection. As expected, the
safety profile from the six-month data was excellent. No serious adverse
events were reported. There were no episodes of either lipoatrophy or
lipodystrophy and there were no injection site tolerability issues. More
importantly, long term safety is supported by the pharmacokinetic and
pharmacodynamics profiles; there was no accumulation and no over-exposure of
IGF-1.
A replay of the webcast is available on OPKO's website, www.opko.com, for the
next 30 days.
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