BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.

The Biotech Times Editorial Team By The Biotech Times Editorial Team
An IV bag with clear liquid hangs from a metal pole in the foreground of a brightly lit medical room with blurred white reclining chairs and a large window in the background.

BridgeBio Pharma has presented exploratory data from its Phase 3 PROPEL 3 trial showing that oral infigratinib produced clinically meaningful improvements in sleep apnea and ear infection rates in children with achondroplasia, adding to the growth and body proportionality findings published earlier this year in the New England Journal of Medicine. The analyses were shared at the Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2026 in Marseille.

The new data extend the picture beyond height velocity. At 52 weeks, the mean total apnea-hypopnea index (AHI) increased by 10.4% in the infigratinib group, compared with 49.2% in the placebo group. In children under eight years old, the effect was more pronounced: AHI was essentially flat in the treated group against a 63.2% increase in placebo recipients. On ear infections, the annualised rate of otitis media was 38% lower with infigratinib overall, and 47% lower in the under-eight subgroup. Body composition results also favoured the drug, with smaller increases in fat mass and visceral fat volume compared with placebo.

Building on primary results

The exploratory analyses build on primary and secondary PROPEL 3 endpoints already in the literature. BridgeBio previously reported a 2.10 cm per year improvement in annualised height velocity versus placebo (p less than 0.0001) and statistically significant improvements in body proportionality in children under eight. Longer-term data from across the PROPEL programme, covering up to three years of treatment, showed a height Z-score change from baseline of +0.92 standard deviations and an upper-to-lower body segment ratio change of -0.15, with no new safety signals identified.

Melita Irving of Guy's and St Thomas' NHS Foundation Trust, London, who presented the longer-term poster at ESPE, said families have consistently emphasised that their priorities extend well beyond the growth chart, and that the sustained findings across growth, proportionality, and these broader outcomes suggest "potential to address a broader range of outcomes that may meaningfully affect a child's health and daily life over time."

Regulatory path and competitive context

BridgeBio has submitted a New Drug Application to the FDA for oral infigratinib in achondroplasia and is targeting a US launch in mid-2027. A Marketing Authorisation Application to the EMA is planned for the fourth quarter of 2026. The drug holds Breakthrough Therapy, Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA; approval could also yield a Priority Review Voucher.

Achondroplasia treatment has become a genuinely competitive space following the approval of vosoritide (BioMarin's Voxzogo), a once-daily subcutaneous injection that targets the same FGFR3 pathway via a CNP analogue mechanism. BridgeBio is positioning infigratinib as the first oral FGFR3 inhibitor in the indication, a differentiation that could carry weight with families and prescribers given the administration convenience for a paediatric chronic condition. The breadth of outcomes data emerging from PROPEL, covering sleep, hearing health, and body composition alongside growth, is likely to be central to BridgeBio's reimbursement and market access arguments in both the US and Europe, where payers are scrutinising the value proposition for high-cost rare-disease medicines with increasing rigour.

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