Detecting and treating growth hormone deficiency
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Publication Number
US-10105352-B2
Publication Date
2018-10-23
Expiration Date
Abstract
Described herein is a new oral method for using MK-0677 for detecting growth hormone (GH) deficiency (GHD). Also described is a method of treating growth hormone (GH) deficiency (GHD) in children with a functional hypothalamic-pituitary GH axis.
Core Innovation
The patent describes a method of treating growth hormone deficiency in children with short stature using oral MK-0677 as a theranostic/diagnostic challenge. It defines equivalent growth potential compared to rhGH by requiring a specific biomarker response after a single oral dose of MK-0677 and a baseline IGF-I threshold, and uses the child’s measured response to guide whether MK-0677 is expected to yield growth potential comparable to rhGH.
The equivalence criteria include a peak serum GH threshold in response to a single oral dose of MK-0677 together with baseline serum IGF-I >30 ng/mL. The document classifies children based on GH secretion potential using a peak serum GH response and baseline IGF-I, and reports that children meeting equivalence criteria respond with a comparable growth response to rhGH.
The described method includes orally administering therapeutically effective amounts of MK-0677 in the range of 0.1–2.0 mg/kg/d to children identified as having equivalent growth potential compared to rhGH. Treatment and administration are tied to a theranostic test that identifies responsiveness, using the measured peak serum GH after a single oral MK-0677 dose and baseline IGF-I.
Claims Coverage
The partial content includes two independent claims centered on using MK-0677 in children with short stature. Across the independent claims, the core inventive features include equivalence-based eligibility criteria using biomarker thresholds, oral MK-0677 administration, and constrained dosing of MK-0677 in mg/kg/d.
Treating short stature children with equivalent growth potential to rhGH using MK-0677
Administering a therapeutically effective amount of MK-0677 to a child known to have short stature and equivalent growth potential compared to rhGH, where equivalence is defined by a peak serum GH ≥5 μg/L in response to a single oral dose of MK-0677 and a baseline serum IGF-I of >30 ng/mL.
Theranostic testing followed by MK-0677 treatment in equivalent-growth-potential children
Testing a child known to have short stature for GHD using a theranostic test, and orally administering a therapeutically effective amount of MK-0677 to a child found to have short stature and equivalent growth potential compared to rhGH, where equivalence is defined by a peak serum GH ≥5 μg/L in response to a single oral dose of MK-0677 and a baseline serum IGF-I of >30 ng/mL.
Both independent claims require identifying pediatric GHD eligibility using equivalence to rhGH based on biomarker thresholds after a single oral MK-0677 dose and baseline IGF-I. The first claim uses the eligibility as a condition for treatment, while the second claim adds performing a theranostic test before oral MK-0677 administration; both constrain the MK-0677 therapeutically effective amount to 0.1–2.0 mg/kg/d.
Stated Advantages
Documented Applications
No documented applications found
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