IMPE2023 Free Communications GH and IGFs 1 (4 abstracts)
Dose-dependent Increase in GH AUC0-12h with LUM-201 in Idiopathic Pediatric GH Deficiency (iPGHD) from the Interim Analysis Data of the OraGrowtH212 Trial
Fernando Cassorla 1 , Rossana Román 1 , Michael L Johnson 2 , Alejandra Avila 1 , German Iñiguez 1 , Ingrid Baier 1 , Daniela Said 1 , Aleksandra Bruchey 3 , Christopher Smith 3 , David B Karpf 3 , John C McKew 3 & Michael O Thorner 3
1Institute of Maternal and Child Research, University of Chile, Santiago, Chile. 2Emeritus University of Virginia, Charlottesville, USA. 3Lumos Pharma, Austin, USA
LUM-201 (ibutamoren), an agonist of the growth hormone (GH) Secretagogue Receptor 1a (GHSR1a), is an investigational oral GH secretagogue currently in three iPGHD Phase 2 trials. The LUM-201 predictive enrichment marker (PEM) may be used to identify patients previously diagnosed with iPGHD who are likely to respond to LUM-201. PEM positivity is defined as a baseline insulin-like growth factor-1 (IGF-1) level >30 ng/mL and a peak GH of ≥5 ng/mL in response to a single 0.8 mg/kg dose of LUM-201. LUM-201, potent and durable, acts on the GHSR1a which is expressed in the hypothalamus and anterior pituitary. LUM-201 enhances the amplitude of endogenous GH pulsatile release over 24 hours, while simultaneously acting as a functional antagonist of the somatostatin receptor. In turn, these effects increase the levels of IGF-1, which together with GH, reach the open growth plates and stimulate growth. Previous data in PEM+ subjects from the Merck 020 study treated with LUM-201 at 0.8 mg/kg/day for 6 months demonstrated a significant increase in the pulsatile release of GH when samples were collected every 20 minutes over 24 hours. Here we report the impact of higher doses of LUM-201,1.6 mg/kg/day and 3.2 mg/kg/day on the increase from baseline in GH AUC0-12h after 6 months of dosing in the OraGrowtH212 Trial. These data are based on samples collected every 10 minutes over 12 hours from 8 am to 8 pm at baseline and at approximately 6 months treatment.
Change from baseline in GH AUC0-12h after 6-months of daily dosing with LUM-201 in PEM+ subjects with iPGHD
| Dose of LUM-201 (mg/kg) | 1.6 | 3.2 |
| N | 4 | 5 |
| Mean (%) | 34.2 | 197.3 |
| Min, Max | -38.3 to 165.4 | 47.9 to 609.6 |
Summary: Across the dose range of 1.6-3.2 mg/kg/day for 6 months, LUM-201 is well-tolerated and produces dose-dependent and substantial increases in GH AUC0-12h in the OraGrowtH212 Trial. In a post hoc analysis of the Merck 020 study, LUM-201 at 0.8 mg/kg/day for 6 months increased AHV comparably to rhGH at 42 mg/kg/day. The greater increases in GH AUC0-12hseen after 6 months of dosing with higher doses of LUM-201 may provide additional gains in AHV in children with iPGHD, and oral LUM-201 may provide an alternative to subcutaneous injection therapy for treating patients with iPGHD. Positive changes in growth velocity will be presented at the meeting.
Article tools
My recent searches
My recently viewed abstracts
Authors
IMPE Abstracts
© Bioscientifica 2025 |
Privacy policy |
Cookie settings
BiosciAbstracts
Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Find out more