Lumos Pharma 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. "We are very pleased to have reached these important milestones, which will allow us to complete our OraGrowtH trials and announce top line results in the fourth quarter of 2023," said Rick Hawkins, Chairman and CEO of Lumos Pharma. "The interim data we announced in November showed that in the 1.6 mg/kg/day LUM-201 arm in the OraGrowtH210 study, mean annualized height velocity of 8.6 cm/yr was observed, in line with 8.3 – 8.6 cm/yr expected based on growth on rhGH for moderate PGHD subjects consistently observed in multiple large datasets. We look forward to building on these initial data, reporting primary outcome results, and continuing to advance our clinical program and planning for our pivotal Phase 3 trial for potentially the first oral therapeutic for PGHD."
Published first on TheFly
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