Lumos Pharma announces new data, analysis of patient from OraGrowtH212 trial

Lumos Pharma announced that an analysis of interim data from its OraGrowtH212 Trial was given as an oral presentation at the 2023 annual meeting of the European Society for Paediatric Endocrinology, held in The Hague, Netherlands, September 21-23, 2023. The oral presentation, Deconvolution Analysis: Oral GH secretagogue enhances growth in individuals with moderate Pediatric Growth Hormone Deficiency by enhancing endogenous GH secretion and increasing IGF-1, was given in a late breaking session. The objective of the analysis was to characterize growth hormone profiles, defined by deconvolution analysis, based on the GH concentration sampled over 12 hours at baseline and after 6 months of therapy with daily oral LUM-201 to illustrate how LUM-201 increases annualized height velocity, total GH secretion, and serum IGF-1 and IGFBP3 in individuals with moderate PGHD. Fifteen prepubertal, naive moderate PGHD subjects were screened with a predictive enrichment marker test to assess their acute response to oral LUM-201, with a positive test having a peak GH greater than or equal to5 ng/ml with a basal IGF-1 greater than30 ng/ml. At baseline, subject were aged 7.9+/-1.4 years, with IGF-1 SDS -0.82+/-0.9, and peak GH 7.2+/-2.2 ng/mL, consistent with moderate PGHD. Deconvolution analysis was performed on serum GH measured every 10 minutes. Patients were randomized to receive 1.6 mg/kg/day or 3.2 mg/kg/day of oral LUM-201. Both baseline characteristics and acute GH responses to the PEM test and the day 1 PEM test doses were not different between the groups. The groups were therefore combined in this analysis. Results showed that after 6 months of treatment with LUM-201, GH, IGF parameters, and AHV increased 60-80% from baseline.