Longeveron's cell therapy flops early walk test study as execs tout flimsy supporting data
Miami biotech Longeveron has sold itself to investors on the promise of using cell therapy to improve the lives of aging patients unable to walk for long distances, but new data don’t look promising at all.
Longeveron’s lomecel-B, a cell therapy for aging frailty, flopped the key six-minute walk test endpoint of a Phase 2b trial of the drug, the biotech said Friday, and investors weren’t pleased.
At 180 days, patients receiving the drug posted no significant improvement on a walk test compared to placebo, Longeveron said, “after adjusting for multiple comparisons using the Hochberg method” to determine false discovery. Lomecel-B is an off-the-shelf product using “medicinal signaling cells” derived from healthy donors’ bone marrow.
But all hope is not lost in Longeveron’s telling: At that same 180-day mark, the drug posted a statistically significant dose-response curve compared with placebo — a positive sign, it said. Meanwhile, Longeveron said patients did post a significant improvement on the walk test at day 270 using what it called a pre-specified analysis, but was not part of the primary endpoint.
What those supporting figures could mean in the long term or whether they have any effect on clinical outcomes is unclear, but Longeveron said it would review the data with an independent steering committee and consider the best path forward for the program.
Meanwhile, Longeveron touted safety data from the study but those data weren’t available in the topline release.
Shares of $LGVN were trading down around 25% late Friday afternoon.
Editor’s Note: This story has been updated.