Data Presented at ENDO 2021 Differentiate LUM-201 from Standard Growth Hormone Secretagogues and Further Support LUM-201’s Potential as a Therapeutic for Pediatric Growth Hormone Deficiency
“These data presented today at the
Poster 7102 presents an analysis of data from a prior clinical study comparing the peak growth hormone (GH) response of LUM-201 (formerly MK-0677) to that of standard GH secretagogues (clonidine, arginine, L-dopa, glucagon, insulin) in children naïve-to-treatment, previously diagnosed with growth hormone deficiency (GHD). The objective was to determine whether LUM-201 stimulates GH responses different from standard GH secretagogues. In this study, a single 0.8 mg/kg oral dose of LUM-201 was administered to 68 prepubertal children with GHD with median baseline age of 9.2 years, height SDS -3.3, pre-treatment height velocity (HV) of 4.0 cm/yr, and baseline IGF-1 of 51 ng/mL. The results showed a median maximal GH response to a single oral dose of LUM-201 of 15.0 ng/mL, a statistically significant difference compared to a 5.4 ng/mL GH peak response to various pairs of standard GH stimulation tests (p<0.00001). In a multivariate analysis (r2 =0.73) differential GH increased with higher values of baseline IGF-1 (p < 0.00001) and standard GH stimulation test (p = 0.047) but was not influenced by age (p = 0.16), sex (p = 0.28), baseline HV (p = 0.24), age-bone age differences (p = 0.33) or height-SDS (p = 0.75).
The analysis demonstrates that in children with GHD, the GH response to a single oral dose of LUM-201 greatly exceeds that observed with standard GH stimulation agents. The difference in GH responses increases with higher baseline concentrations of IGF-1 and higher GH stimulation test results. The synergistic actions of LUM-201 on the physiological mechanisms regulating GH release explain why GH responses are greater in response to LUM-201 compared to traditional tests used to diagnose PGHD and indicates that the greatest differences may be found in children with more moderate degrees of GHD.
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