Drugs / BBP-631
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04783181 | Jul 2021 → Feb 2029 expected | classic congenital adrenal hyperplasia | Adrenas Therapeutics Inc | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-09-10 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma reports topline results from phase 1/2 trial of investigational gene therapy for congenital adrenal hyperplasia (cah) bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced topline results from the Phase 1/2 open-label ADventure study investigating BBP-631, the Company’s investigational adeno-associated virus (AAV) 5 gene therapy, for the treatment of congenital adrenal hyperplasia (CAH). |
| 2021-05-14 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma receives fda fast track designation for investigational gene therapy for congenital adrenal hyperplasia bridgebio.com ↗
The FDA’s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible. |
| 2019-10-22 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma gene therapy subsidiaries present data demonstrating potential in two rare disease indications at the european society of gene and cell therapy conference bridgebio.com ↗
Preclinical data shows promise for gene therapy candidates for congenital adrenal hyperplasia due to 21-hydroxylase deficiency (BBP-631) and Canavan disease (BBP-812) |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-09-10 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma reports topline results from phase 1/2 trial of investigational gene therapy for congenital adrenal hyperplasia (cah) bridgebio.com ↗ |
| 2023-10-03 | Eidos Therapeutics, a BridgeBio company | bridgebio and resilience announce strategic multi-year partnership to advance bbp-631, bbp-812 and future gene therapy treatments bridgebio.com ↗ |
| 2021-05-14 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma receives fda fast track designation for investigational gene therapy for congenital adrenal hyperplasia bridgebio.com ↗ |
| 2019-10-22 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma gene therapy subsidiaries present data demonstrating potential in two rare disease indications at the european society of gene and cell therapy conference bridgebio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBP-631 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04783181 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “Adeno-Associated Virus (AAV) Serotype 5-Based Recombinant Vector” NCT04783181 ↗ |
| Route | Intravenous | “BBP-631 lowest dose, administered once, intravenously (IV)” NCT04783181 ↗ |