Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05504837 | A Study Assessing KB407 for the Treatment of Cystic Fibrosis | PHASE1 | RECRUITING | 20 | — | — | Jun 30, 2023 | Mar 1, 2027 | May 7, 2026 | 6 | United States |
Number of adult subjects with treatment related adverse events as assessed by NCI-CTCAE v5
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (open label) | EXPERIMENTAL | A single administration of KB407 |
| Cohort 2 (open label) | EXPERIMENTAL | Two administrations of KB407 |
| Cohort 3 (open label) | EXPERIMENTAL | Four administrations of KB407 |
| Cohort 4 (open label) | EXPERIMENTAL | Four consecutive administrations of KB407 followed by weekly administration for up to 6 months |
| Name | Type | Description |
|---|---|---|
| KB407 (Nebulization) | BIOLOGICAL | Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR |
Inclusion Criteria: 1. The subject must have read, understood, and signed an Institutional Review Board/Ethics Committee (IRB/IEC) approved Informed Consent Form and must be able to and willing to follow study procedures and instructions 2. Subjects aged 18 years or older at the time of Informed Co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |