Detecting and treating growth hormone deficiency
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Publication Number
US-11234969-B2
Publication Date
2022-02-01
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 an oral MK-0677 (ibutamoren mesylate) theranostic approach for childhood growth hormone deficiency (GHD) and growth hormone insufficiency (GHI), in which a single oral dose of MK-0677 is used to test GH secretory capacity. The test is characterized by a peak serum GH threshold (≥55 μg/L in response to the single oral dose) and a baseline serum IGF-I threshold (>30 ng/mL). These biomarker criteria are used to identify children with adequate GH secretion potential and equivalent growth potential compared to daily subcutaneous recombinant human GH (rhGH).
The patent further describes administering oral MK-0677 to children meeting the biomarker criteria, with the goal of achieving height velocity comparable to rhGH. It also describes differentiation between subpopulations based on GH secretory potential, indicating that children with lower GH secretory potential respond less to MK-0677. The approach relates an oral GH secretory capacity test to expected growth outcomes versus rhGH.
The document includes Phase IIb clinical study results comparing placebo, MK-0677, and rhGH, including differentiated growth responses in stratified groups (LOW vs EQUAL). It also describes correlations between baseline IGF-I and acute GH response to MK-0677, and relates these findings to standard provocative tests used for classification and comparison.
Claims Coverage
The partial content provides two independent claims, each directed to treating pediatric GHD by administering MK-0677 to children defined as having short stature and equivalent growth potential compared to rhGH using the same biomarker-response criteria, with different specified MK-0677 daily dose ranges.
Treating pediatric GHD with MK-0677 using equivalent growth potential criteria
Administering a therapeutically effective amount of MK-0677 to a child known to have short stature and equivalent growth potential compared to rhGH, wherein the therapeutically effective amount is 0.1-0.8 mg/kg/d and equivalent growth potential is when the child has 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.
Treating pediatric GHD with MK-0677 using equivalent growth potential criteria
Administering a therapeutically effective amount of MK-0677 to a child known to have short stature and equivalent growth potential compared to rhGH, wherein the therapeutically effective amount is 0.8-2.0 mg/kg/d and equivalent growth potential is when the child has 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 define a treatment selection framework in which children with short stature are treated with MK-0677 at a specified daily dose range, provided they meet the same biomarker-defined equivalent growth potential criteria based on a peak serum GH response after a single oral MK-0677 dose and a baseline serum IGF-I level.
Stated Advantages
Achieve height velocity comparable to rhGH in children meeting the biomarker criteria.
Differentiate subpopulations, indicating that children with low GH secretory potential respond less to MK-0677.
Documented Applications
Use an oral single-dose MK-0677 GH secretory capacity test using peak serum GH and baseline serum IGF-I thresholds to identify children with equivalent growth potential compared to rhGH.
Treat children with GHD using oral MK-0677 when the children meet the biomarker criteria for equivalent growth potential versus rhGH.
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