LUMO - Lumos growth hormone deficiency candidate meets expectations in mid-stage trials

Lumos Pharma ( NASDAQ: LUMO ), a biotech focused on rare diseases, announced Monday that its lead asset, LUM-201 met expectations in an interim analysis of two Phase 2 trials for Pediatric Growth Hormone Deficiency (PGHD).

The OraGrowtH210 and OraGrowtH212 trials were designed to evaluate the oral medication in children with moderate (idiopathic) pediatric growth hormone deficiency (PGHD).

The 80-subject OraGrowtH210 trial tested three dose levels (0.8, 1.6, 3.2 mg/kg/day) of LUM-201 compared to injectable recombinant human growth hormone (rhGH).

According to Lumos ( LUMO ), interim data from 41 subjects of the study indicated a mean annualized height velocity (AHV) of 8.6 cm at six months for 1.6 mg/kg/day dose of LUM-201, meeting the company expectations of 8.3 cm AHV which were based on historical comparisons.

The AHV results in the open-label OraGrowtH212 were also found to be comparable to the data from OraGrowtH210.

Data from both OraGrowtH trials indicated a comparable safety and tolerability profile between LUM-201 and rhGH subjects.

“We are elated that our candidate for the first oral therapeutic for treatment of PGHD, LUM-201, performed as predicted in these moderate (idiopathic) PEM-positive PGHD subjects,” Chief Executive of Lumos ( LUMO ) Rick Hawkins remarked.

Before the OraGrowtH readout, the company announced its Q3 2022 results.

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