According to a post-hoc analysis of the results of the Lumina-1 phase II trial of garetosmab versus placebo in fibrodysplasia ossificans progressiva (FOP) :
- almost three-quarters (71%) of participants in the placebo group experienced inflammatory flare-ups during the first 28 weeks of the trial, i.e. the double-blind phase;
- the majority (59%) developed a new heterotopic ossification at the same time, usually at a different site from that of the flare, and with a greater overall volume (16.6 cm3 vs. 3.2 cm3) than the ossifications in patients who did not experience flares during the same period;
- garetosmab reduced the median duration of relapses (15 days versus 48 days for placebo), their severity and the need for corticosteroid therapy (40% versus 58.3%).
The phase III trial (Optima) is now continuing to evaluate garetosmab in 63 patients with FOP.
