Disc Medicine Announces Success on All Primary and Secondary Endpoints in the Pivotal Phase 3 APOLLO Trial of Bitopertin in Adults and Adolescents with Erythropoietic Protoporphyria (EPP)
Disc Medicine's pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria met all primary and secondary endpoints with statistical significance. Bitopertin achieved a -41.4% reduction in whole-blood PPIX vs placebo (p<0.0001) and a +12.2 hour increase in monthly time in light without pain (p=0.0010), with no new safety signals and no TEAEs above Grade 3 in the 183-patient study.
Key figures
- Drug Name
- bitopertin
- Phase Of Trial
- Phase 3
- Disease
- erythropoietic protoporphyria (EPP), including X-linked protoporphyria (XLP)
- Trial name
- APOLLO
- Pix reduction
- -41.4% vs placebo, p<0.0001
- Dizziness teae
- 50% (mild/moderate, transient); no TEAEs above Grade 3
- Enrolled patients
- 183
- Ndaa resubmission
- NDA resubmission to FDA by end of 2026; FDA decision anticipated mid-2027
- Time in light increase
- +12.2 hours/month vs placebo, p=0.0010
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