UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
Recent Developments
Interim Results from Phase 2 Trial of Infigratinib in Achondroplasia
On July 26, 2022, BridgeBio Pharma, Inc. (“BridgeBio”) announced positive interim results from PROPEL 2, a Phase 2 trial of infigratinib in children with achondroplasia. This corresponds to a median of 48.1 weeks for the 62 participants included in the safety population at the time of the interim analysis. The data demonstrated:
| • | At the highest dose level evaluated to date (Cohort 4, 0.128 mg/kg once daily), the mean increase in annualized height velocity (“AHV”) was +1.52 cm/yr over baseline (p = 0.02, n=11) in children 5 years of age and older based on the longest available follow-up data at time of interim analysis, 64% of whom were responders (defined as >25% increase in AHV from baseline); the average percent change from baseline in AHV was 60% |
| • | In children age 3 to <5 years old, the increase in ACH height Z-score, which controls for age and gender differences seen in height changes, at 6 months was 0.21 Standard Deviation Score. This group also demonstrated an increase in AHV of +0.61 cm/yr over baseline (n=5) |
| • | Across Cohort 4, the median duration of follow-up was 26.9 weeks at time of interim analysis |
| • | No serious adverse events and discontinuations due to adverse events have been reported to date in any cohort, including Cohort 5, which has not yet completed enrollment. The majority of adverse events (“AEs”) observed were Grade 1, unrelated to study drug, and consistent with a pediatric achondroplasia population. Only 9.7% of subjects had a treatment-emergent AE assessed as related to study drug, all of which were Grade 1, and only one treatment-related dose reduction has been made to date |
BridgeBio, after discussions with regulatory agencies, has begun enrolling Cohort 5. Cohort 5 is receiving approximately twice the dose of Cohort 4 (0.25 mg/kg once daily vs 0.128 mg/kg once daily in Cohort 4). At the conclusion of the ongoing trial, BridgeBio intends to present full data at a medical conference in the first half of 2023.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BridgeBio Pharma, Inc. | ||||||
| Date: July 26, 2022 | /s/ Brian C. Stephenson | |||||
| Brian C. Stephenson | ||||||
| Chief Financial Officer | ||||||