IMPE2023 Poster Presentations GH and IGFs (14 abstracts)
Baseline Demographics of the OraGrowtH210 Trial Studying LUM-201 in Idiopathic Pediatric Growth Hormone Deficiency (iPGHD) Interim Analysis Data
Alison Lunsford 1 , Beata Wikiera 2 , Andrew Dauber 3 , Beata Pyrzak 4 , Artur Bossowski 5 , Michael Tansey 6 , Elzbieta Petriczko 7 , Renata Stawerska 8,9 , Sasigarn Bowden 10 , Matthew Feldt 11 , Michael Everett Gottschalk 12 , Monica Marin 13 , Sunil Nayak 14 , Bhuvana Sunil 15 , Elzbieta Moszczynska 16 , David Repaske 17 , Leslie Soyka 18 , John Fuqua 19 , Oscar Escobar 20 , Deborah Bowlby 21 , Patricia Y. Fechner 22 , Esko Wiltshire 23 , Mark Harris 24 , Kupper Wintergest 25 , Antony R Lafferty 26 , Bradley S Miller 27 , Peter Simm 28 , Aleksandra Bruchey 29 , Christopher Smith 29 , David B Karpf 29 , John C McKew 29 & Michael O Thorner 29
1Texas Tech HSC Amarillo, Amarillo, USA. 2Klinika Endokrynologii i Diabetologii Wieku Rozwojowego UM, Wrocław, Poland. 3Children’s National Hospital, Washington DC, USA. 4Department of Pediatric and Endocrinology Medical University of Warsaw, Warsaw, Poland. 5Department of Pediatric Endocrinology and Diabetes with a Cardiology Division. Medical University in Białystok, Poland, Białystok, Poland. 6University of Iowa, Iowa City, USA. 7Sonomed Clinic, Szczecin, Poland. 8Polish Mother’s Memorial Hospital – Research Institute, Łódź, Poland. 9Medical University of Lodz, Łódź, Poland. 10Nationwide Children’s Hospital, Columbus, USA. 11Children’s Mercy Hospital and Clinics, Kansas City, USA. 12University of California San Diego/Rady Children’s Hospital, San Diego, USA. 13Oklahoma Children’s Hospital OU Health, Oklahoma City, USA. 14Pediatric Endocrine Associates, Greenwood Village, USA. 15Mary Bridge Children's Hospital and Health Center, Tacoma, USA. 16Memorial Institute Children's Health Center, Warsaw, Poland. 17University of Virginia, Charlottesville, USA. 18UMass Chan Medical School, Worcester, USA. 19Indiana University School of Medicine, Indianapolis, USA. 20UPMC Children’s Hospital of Pittsburgh, Pittsburgh, USA. 21Medical University of South Carolina, Charleston, USA. 22Seattle Children’s/University of WA, Seattle, USA. 23University of Otago Wellington, Wellington, New Zealand. 24Queensland Children's Hospital, South Brisbane, Australia. 25University of Louisville, Louisville, USA. 26Canberra Hospital and Australian National University Medical School, Canberra, Australia. 27University of Minnesota Medical School, Minneapolis, USA. 28Royal Children's Hospital, Melbourne, Australia. 29Lumos 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. A LUM-201 predictive enrichment marker (PEM) may be used to select previously diagnosed iPGHD patients likely to respond to LUM-201. PEM positivity is defined as 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 oral 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 pulsatile releases of GH over 24 hours, while simultaneously acting as a functional antagonist at 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. The OraGrowtH210 Trial is a multi-center Phase 2 trial randomizing 80 iPGHD PEM+ subjects equally to 3 LUM-201 doses (0.8, 1.6, or 3.2 mg/kg/day) or to recombinant human GH (rhGH) at 34 µg/kg/day dose. This abstract depicts the baseline demographics in the protocol-specified six-month interim analysis (IA) subset.
OraGrowtH210 Trial IA Baseline Demographics Shown to Impact Growth
| Subjects (41) | 0.8 n=11 | 1.6 n=10 | 3.2 n=10 | rhGH n=10 |
| Mean (SD) | ||||
| Age (mos) | 95.5 (28.2) | 99.3 (28.3) | 96.1 (21.7) | 90.3 (26.7) |
| Height (cm) | 113.8 (12.6) | 114.6 (9.6) | 113.8 (8.8) | 111.6 (11.9) |
| Height SDS | -2.31 (0.32) | -2.35 (0.62) | -2.30 (0.48) | -2.28 (0.43) |
| IGF-1 SDS | -1.24 (0.570) | -1.17 (0.72) | -1.39 (0.61) | -1.37 (0.48) |
| MPH (cm) | 164.47 (6.44) | 166.98 (7.15) | 166.20 (8.06) | 168.78 (8.54) |
| MPH SDS ∆ | 1.29 (0.62) | 1.76 (0.60) | 1.96 (0.83) | 1.76 (0.73) |
| BA Delay (yrs) | 1.89 (1.07) | 1.91 (0.53) | 2.19 (0.86) | 1.78 (0.96) |
| BMI SDS | -0.29 (1.10) | -0.35 (0.79) | -0.70 (0.48) | +0.31 (1.05) |
| Male/Female (%) | 64/36 | 60/40 | 40/60 | 70/30 |
Summary: Randomization did not result in a balance of growth predictive factors due to small cohort numbers at the IA. The factors predicting improved first year growth (younger age, shorter stature, greater MPH, and higher BMI) occurred in the rhGH cohort (shown in bold). The full data set of 80 subjects should better balance the factors that are related to growth across all four cohorts. The IA 6-month annualized height velocity will be presented at the meeting.
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