Oral Infigratinib Shows Meaningful Benefits Beyond Growth Within 52 Weeks in Children with Achondroplasia in the Phase 3 PROPEL 3 Trial
BridgeBio presented new exploratory analyses from the Phase 3 PROPEL 3 trial of oral infigratinib in children with achondroplasia. The data show favorable trends in sleep apnea measures and a 38% reduction in ear infection rates compared to placebo. The company submitted an NDA to the FDA and anticipates a U.S.
Key figures
- Drug Name
- oral infigratinib
- Phase Of Trial
- Phase 3
- Ahv improvement
- +2.10 cm/year
- Bmi change placebo
- 0.93 kg/m(2)
- Height z score year3
- +0.92 SD
- Bmi change infigratinib
- 0.50 kg/m(2)
- Upper to lower ratio year3
- -0.15
- Otitis media rate reduction
- 38%
- Body fat mass change placebo
- 1.12 kg
- Sleep apnea increase placebo
- 49.2%
- Lean body mass change placebo
- 1.58 kg
- Body fat mass change infigratinib
- 0.95 kg
- Sleep apnea increase infigratinib
- 10.4%
- Lean body mass change infigratinib
- 1.77 kg
- Otitis media rate reduction under8
- 47%
- Visceral fat volume change placebo
- 18.42 mL
- Sleep apnea increase placebo under8
- 63.2%
- Visceral fat volume change infigratinib
- 1.55 mL
AI analysis
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