Lumos Pharma, Inc. announced that the last subjects have been enrolled and randomized in the Company's OraGrowtH210 and OraGrowtH212 trials evaluating LUM-201 for the treatment of moderate idiopathic PGHD. The Company now expects data on 82 subjects in the OraGrowtH210 Trial and 22 subjects in the PK/PD OraGrowtH212 Trial. The OraGrowtH210 Trial is a multi-site, global trial evaluating orally administered LUM-201 at three dose levels (0.8, 1.6, 3.2 mg/kg/day) against a standard dose of injectable rhGH in approximately 80 subjects diagnosed with idiopathic (moderate) PGHD.

The objective of this trial is to identify the optimal dose of LUM-201 to be used in a Phase 3 registration trial, based on annualized height velocity from a 6-month dataset, and to prospectively confirm the utility of Predictive Enrichment Marker (PEM) strategy. The interim analysis demonstrated that LUM-201 in the 1.6 mg/kg/day arm met expectations at six months of treatment with an AHV of 8.6 cm as compared to the AHV of 8.3 cm observed in the PEM-positive moderate naive-to-treatment PGHD subjects for 12 months on rhGH as derived from the large 20-year Phase 4 Eli Lilly GeNeSIS database. The complete set of six-month, primary outcome data for 82 subjects is anticipated in the fourth quarter of 2023.

Subjects will be treated for up to 24 months. OraGrowtH212 Trial Evaluating PK/PD and Pulsatility of Oral LUM-201 in PGHD. The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) effects of oral LUM-201 in up to 24 PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day.

The primary objective of the OraGrowtH212 Trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone from LUM-201 therapy, contributes to its efficacy in PGHD. The primary endpoint for this trial is six months of PK/PD (pulsatility) and height velocity data in 22 subjects. Subjects will be allowed to remain on treatment until they reach their near-adult height.

Primary data readout in 22 subjects is anticipated in the fourth quarter of 2023. Switch Study, OraGrowtH213 Trial, Evaluating LUM-201 in OraGrowtH210 Subjects Previously on rhGH. The OraGrowtH213 Trial is an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD subjects who have completed the OraGrowtH210 Trial.

Subjects are administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months. This trial is currently enrolling subjects.