Lumos Pharma announces results from FDA meeting on LUM-201

Lumos announced that the FDA indicated that a placebo-controlled trial design is an appropriate option for a Phase 3 trial for LUM-201. The company believes this reflects FDA’s recognition of unique qualities of LUM-201’s mechanism of action as a growth hormone secretagogue. Proposal for a Phase 3 trial to include a 12-month double-blinded, placebo-controlled design with 2:1 randomization, approximately 150 patients with the placebo-controlled portion of the study lasting six months, which Lumos believes will improve the likelihood of success when compared to a non-inferiority study.Planning is ongoing, and the company expects to initiate a Phase 3 trial of LUM-201 in Q4 2024, subject to FDA approval. “In addition to our encouraging engagement with the FDA, we are also very pleased to share updated data from our Phase 2 OraGrowtH trials. These data continue to show that LUM-201 produces a significant increase in growth from baseline in annualized height velocity (AHV) at 6 and 12 months in per protocol analysis. Combined data also suggest durable benefit out to 24 months. We believe these developments have positioned us to advance LUM-201 toward both a Phase 3 registrational trial and potential approval of LUM-201 as the first oral therapeutic for moderate pediatric growth hormone deficiency,” Rick Hawkins concluded.