BridgeBio Announces Publication in the New England Journal of Medicine of Phase 3 PROPEL 3 Trial of Oral Infigratinib in Children Living with Achondroplasia
BridgeBio published pivotal Phase 3 PROPEL 3 data for oral infigratinib in achondroplasia in the New England Journal of Medicine, marking the first such publication for an achondroplasia trial. The study met its primary endpoint with a least-squares mean treatment difference of +1.74 cm/yr in annualized height velocity versus placebo, and an observed mean difference of +2.10 cm/yr, the largest reported in any Phase 3 achondroplasia study.
Key figures
- Drug Name
- oral infigratinib
- Phase Of Trial
- Phase 3
- Hyperphosphatemia cases
- 3
- Hyperphosphatemia percentage
- 4%
- Arm span z score ls mean diff
- +0.37 SD
- Primary endpoint ls mean diff
- +1.74 cm/yr
- Height z score ls mean increase
- +0.41 SD
- Discontinuations related to drug
- 0
- Body proportionality ls mean diff
- -0.05
- Primary endpoint observed mean diff
- +2.10 cm/yr
- Serious adverse events related to drug
- 0
AI analysis
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