Detecting and treating growth hormone deficiency
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Publication Number
US-10898472-B2
Publication Date
2021-01-26
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 invention relates to a theranostic test for treating a child having a growth hormone deficiency using MK-0677. The test combines measurement of a child’s peak serum GH in response to a single oral dose of MK-0677 with measurement of the child’s baseline serum IGF-I. The approach defines patient groupings based on those biomarkers to support treatment selection with growth comparable to daily subcutaneous rhGH.
A patient group with “EQUAL growth potential” is characterized by peak serum GH that is at least 5 μg/L after the single oral dose of MK-0677 and by baseline serum IGF-I above 30 ng/mL. The narrative contrasts this with “LOW” or severely deficient patients, characterized by peak GH at or below 5 μg/L and/or low baseline IGF-I, which is associated with less favorable response to oral MK-0677.
The description links test performance to correlations with baseline IGF-I and reports pediatric Phase IIb study outcomes, including height velocity changes, showing oral MK-0677 performance comparable to rhGH in the EQUAL group while overall group response favors rhGH. The described use also includes association with standard provocative GH tests and outpatient testing concepts, together with definitions and cutoffs for selecting children likely to respond.
Claims Coverage
The partial content includes one independent claim and specifies a theranostic test using two quantitative inventive measurements. The claim includes two inventive features corresponding to eligibility based on peak serum GH after an oral MK-0677 challenge and baseline serum IGF-I above a threshold.
Theranostic test based on peak serum GH after a single oral MK-0677 dose
Testing the child for a peak serum GH at least 5 μg/L in response to a single oral dose of MK-0677.
Theranostic test based on baseline serum IGF-I threshold
Testing the child for a baseline serum IGF-I of greater than 30 ng/mL.
Across the independent claim, the theranostic test specifies eligibility using biomarker thresholds: peak serum GH after a single oral dose of MK-0677 and baseline serum IGF-I above 30 ng/mL.
Stated Advantages
Oral MK-0677 shows height velocity changes comparable to rhGH in the EQUAL group.
Overall group response favors rhGH.
The test supports identifying children with growth comparable to daily subcutaneous rhGH.
Documented Applications
Diagnosing growth hormone deficiency in a child and selecting children likely to respond with growth comparable to daily subcutaneous rhGH using a theranostic approach based on MK-0677-induced peak serum GH and baseline serum IGF-I.
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