Disc Medicine Expands Phase 3 APOLLO Trial to 183 Patients, Data Due Q4 2026
Disc Medicine completed enrollment of 183 patients in its pivotal Phase 3 APOLLO trial of bitopertin for erythropoietic protoporphyria, surpassing the original 150-participant plan due to strong demand. Topline results are expected in Q4 2026, with an FDA decision on the submission anticipated by mid-2027.
1. Enrollment Completion and Expansion
Disc Medicine has completed enrollment of 183 participants in its pivotal Phase 3 APOLLO trial of bitopertin for erythropoietic protoporphyria, exceeding the original 150 patient target due to strong patient and physician demand.
2. Trial Design and Endpoints
APOLLO is a double blind, placebo controlled study in patients aged 12 and above across the US, Canada, Europe and Australia, with co primary endpoints measuring average monthly sunlight exposure without pain and percent change in metal free protoporphyrin IX after six months.
3. Data Timeline and Regulatory Path
Topline results from APOLLO are expected in Q4 2026, after which a complete response letter submission will be made and an FDA decision is anticipated by mid 2027.
4. Bitopertin Background and Development
Bitopertin is an oral GlyT1 inhibitor designed to modulate heme biosynthesis, currently in multiple clinical trials for erythropoietic porphyrias and developed under a global license from Roche.