Encouraging Data from Lumos Pharma OraGrowtH Trials Presented at Annual Pediatric Endocrine Society Meeting (PES)

Oral and Poster Presentations on OraGrowtH Trials at PES 2023 Further Support Potential for LUM-201 as First Oral Treatment for Moderate Idiopathic PGHD

OraGrowtH212 Interim Data Demonstrate LUM-201 Amplifies Natural Pulsatile GH-Secretion and that IGF-1 SDS and Serum Concentrations Remain within Normal Range

AUSTIN, Texas, May 08, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for idiopathic Pediatric Growth Hormone Deficiency (iPGHD) through Phase 2 clinical trials, announced today that interim data from its OraGrowtH210 Trial were reviewed in an oral presentation at the 2023 Annual Meeting of the Pediatric Endocrine Society (PES), held in San Diego, California, May 5-8, 2023. Data from the interim analysis of its OraGrowtH212 Trial were also presented in a poster session during the conference.

Oral Presentation on Phase 2 Dose-finding OraGrowtH210 Trial (link)

• Title (Abstract 6178) – Growth Response to LUM-201 in the OraGrowtH210 Trial in Idiopathic Pediatric Growth Hormone Deficiency (iPGHD): Interim Analysis Data (41 Subjects)
• Lead Author – Andrew Dauber, MD, Chief of Endocrinology, Children’s National Medical Center, Washington, D.C.
• Conclusions:
  • In a selected patient population (idiopathic PGHD) using the LUM-201 PEM (Prediction Enrichment Marker), LUM-201 demonstrates an increase in height velocity with three doses of this oral growth hormone secretagogue.
  • Oral LUM-201 1.6 mg/kg/day cohort grew 8.6 cm/year, in line with the expected historical rate of ~ 8.3 - 8.6 cm/year from prior data of moderate iPGHD rhGH treated patients.
  • No treatment-related Serious Adverse Events (SAEs) and no meaningful safety signals observed in either laboratory values, adverse event data, or in electrocardiogram values.

Poster Presentation on Phase 2 PK/PD Mechanistic OraGrowtH212 Trial (link)

• Title (Abstract 6197) – Observed Serum IGF-1 Concentration Increase Within Normal Range After Prolonged Daily Oral LUM-201 Administration in Idiopathic Pediatric Growth Hormone Deficiency from the OraGrowtH212 Trial: Interim Analysis Data
• Lead Author – Fernando Cassorla, MD, Chief of Pediatric Endocrinology, University of Chile
• Conclusions:
  • LUM-201, at doses of 1.6 mg/kg/day and 3.2 mg/kg/day, increases the natural pulsatile release of GH in children with iPGHD.
  • These increases in GH AUC in turn stimulate an increase in IGF-1 and IGF-1 SDS, which increases growth in children with iPGHD; all subjects demonstrated an increase in AHV.
  • Both of the doses of LUM-201 showed acceptable safety and tolerability.
  • The preliminary optimal dose, based on the controlled dose range finding study, OraGrowtH210 Trial, is 1.6 mg/kg/day, as it produced increases in AHV that were comparable to the higher dose of 3.2 mg/kg/day.
  • Given the modest imbalance in baseline demographics, including baseline AHV, between the two dose groups in the OraGrowtH212 interim analysis, the 6, 9, and 12-month AHV values appear to be comparable in the trial.
  • Due to the natural negative feedback mechanisms, even doubling the optimal dose from 1.6 to 3.2 mg/kg/day did not result in IGF-1 SDS values outside of the normal range.
  • The increase in AHV over 6 months in the OraGrowtH212 Trial appears to be primarily related to lower baseline AHV than dose.
  • Pending the final analysis in 4Qtr 2023, the optimal dose currently appears to be 1.6 mg/kg/day.