Lumos Pharma Delays Data Readout From Pediatric Growth Hormone Deficiency Trial To 2H Of 2023

Lumos Pharma Inc LUMO expects 6-month primary outcome data from Phase 2 OraGrowtH210 Trial of LUM-201 in the 2H of 2023, citing the pace of site initiation and slower than anticipated enrollment due to COVID-19 restrictions.

• Earlier, the data read-out for the OraGrowtH210 Trial was expected in mid-2022.
• The OraGrowtH210 trial of LUM-201 is targeting Pediatric Growth Hormone Deficiency (PGHD).
• The FDA has also requested an extension of the OraGrowtH210 Trial to 12 months. 
• The planned protocol extension mirrors the first six months of the OraGrowtH211 long-term extension study. 
• The agency has placed its planned long-term extension study on partial clinical hold until additional efficacy data from the OraGrowtH210 Trial are available to be reviewed. 
• Also, the OraGrowtH212 Trial of LUM-201 in PGHD will be extended from six months to twelve months to capture additional PK/PD and height velocity data.
• The PD pulsatility assessment will continue to be at six months on therapy as planned.
• The Company will hold a conference call and webcast for today at 8:30 a.m. ET.
• Price Action: LUMO shares closed at $9.37 on Tuesday.
• Related content: Benzinga's Full FDA Calendar.