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Lumos Pharma Inc (NASDAQ:LUMO) announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints.
In March, BridgeBio Pharma Inc (NASDAQ:BBIO) said that at the highest dose level evaluated (Cohort 5, 0.25 mg/kg once daily), the mean increase from baseline in annualized height velocity for the ten children with six-month visits was +3.03 cm/yr.
Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment, comparable to growth rates for Moderate pediatric growth hormone deficiency population.
These AHVs aligned with the company's expectations for 8.3-8.6 cm/yr AHV observed after 12 months of rhGH treatment in a moderate PGHD patient population.
Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months.
Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified.
The trial met the pre-specified primary endpoint of validation of the Predictive Enrichment Marker (PEM) test and the secondary endpoint demonstrating 100% reproducibility of PEM-Positive classification.
Lumos Pharma's Q3 cash of $42.7 million is expected to provide a runway through Q3 2024.
Price Action: LUMO shares are up 13.80% at $4.14 on the last check Wednesday.
