Date: 2014-06-23
Type of information: Results
phase: 2
Announcement: results
Company: OPKO Health (USA - FL)
Product: Lagova™ ( long-acting CTP-enhanced human growth hormone [hG])
Action
mechanism: Lagova™ is a long-acting CTP-enhanced human growth hormone.
Disease: pediatric growth hormone deficiency disorder
Therapeutic area: Hormonal diseases - Genetic diseases - Endocrine diseases
Country:
Trial
details: The randomized, comparator-controlled Phase 2 study was conducted in up to 56 pre-pubertal, naïve GHD children receiving one of three Lagova doses as once-weekly regimen (0.25, 0.48, 0.66mg/Kg/week; equivalent of 0.18, 0.35, 0.48 mg/Kg/week of hGH) or daily hGH (34µg/Kg/day) subcutaneously. In order to introduce naïve patients to the allocated Lagova dose in a gradual manner, a stepwise dose increase approach was implemented. Once patients reached the targeted doses, Lagova, GH, IGF-1 and IGF-BP3 concentrations were measured and PK-PD analysis was conducted utilizing a population based approach.
Latest
news: * On June 23, 2014, OPKO Health a multinational biopharmaceutical and diagnostics company, announced 6 month results of a Phase 2 dose-finding study evaluating the safety and efficacy of its novel long-acting human growth hormone product Lagova™ to treat pediatric growth hormone deficiency disorder (GHD). All three Lagova™ once-weekly doses demonstrate strong catch-up growth during the six months treatment. The baseline characteristics of all patients were comparable among all groups. Interim analysis of the PK profile following administration of Lagova demonstrates a significantly extended half-life as reflected by the T1/2 and AUC respectively. A dose dependent PD (IGF-1) response was observed between Lagova cohorts, reaching steady state with no accumulation or excessive levels. All cohorts demonstrated promising “catch-up” growth, in line with reported age and GHD severity-matched data. The annualized height velocities are more than 12 cm, which correlates with the PK/PD profile in those patients. The interim results further affirm that a once-weekly administration of Lagova can replace daily injections of marketed hGH in pediatric GHD patients. The results enable dose selection for the company’s upcoming Phase 3 pediatric trial,” said Dr. Ron Rosenfeld, clinical advisor on the study and professor of Pediatrics (emeritus), Stanford University and professor of Pediatrics at Oregon Health and Science University (emeritus). “Because Lagova consists of native human growth hormone attached to a C-Terminal Peptide of endogenous hormone, one would anticipate low immunogenicity,” Rosenfeld noted. OPKO Health now plans to move into a single confirmatory pivotal Phase 3 study for pediatric GHD patients.
