- Lumos Pharma Inc LUMO announced interim results from its Phase 2 OraGrowtH210 Trial and Phase 2 Pharmacokinetic/Pharmacodynamic (PK/PD) OraGrowtH212 Trial of oral LUM-201 for moderate (idiopathic) pediatric growth hormone deficiency (PGHD).
- The mean (median) AHV at six months is shown below for each of the four treatment arms:
- 7.26 (7.71) cm/year in the 0.8 mg/kg/day LUM-201 arm (n=11)
- 8.57 (8.61) cm/year in the 1.6 mg/kg/day LUM-201 arm (n=10)
- 7.77 (8.11) cm/year in the 3.2 mg/kg/day LUM-201 arm (n=10)
- 11.05 (10.48) cm/year in the rhGH arm (n=10)
- Interim results for approximately 50% enrollment (n=41) of OraGrowtH210 Trial demonstrated a mean annualized height velocity (AHV) of 8.6 cm at six months for 1.6 mg/kg/day LUM-201, in line with 8.3 cm AHV expected from historical database comparisons.
- The company noted that the unexpected growth was likely due to the presence of two of the youngest subjects in the rhGH cohort known to show a robust growth response and other imbalances in several baseline characteristics.
- The company believes the imbalance in age will even out as enrollment progresses.
- OraGrowtH210 Trial is now ~80% enrolled, and the company continues to anticipate primary outcome readout with all 80 subjects at six months in 2H 2023.
- Lumos ended Q3 with a cash balance of $73.7 million, providing a runway into Q2 2024.
- Price Action: LUMO shares are down 21.20% at $7.02 on the last check Monday.
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