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Also known as SP-101 and doxorubicin Cohort 1
SP-101 · 1 trial · 1 indication
Safety and tolerability of SP-101 following a single inhalation dose, as assessed by incidence and severity of treatment emergent adverse events, serious adverse events, and dose limiting toxicities, including clinically significant changes from baseline to scheduled time points in safety parameters.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single inhalational administration of SP-101 and doxorubicin Dose 1 |
| Cohort 2 | EXPERIMENTAL | Single inhalational administration of SP-101 and doxorubicin Dose 2 |
| Dose Expansion | EXPERIMENTAL | Single inhalational administration of SP-101 and doxorubicin Selected Dose |
| Name | Type | Description |
|---|---|---|
| SP-101 and doxorubicin Cohort 1 | COMBINATION_PRODUCT | Single inhaled dose of SP-101 and doxorubicin Dose 1 |
| SP-101 and doxorubicin Cohort 2 | COMBINATION_PRODUCT | Single inhaled dose of SP-101 and doxorubicin Dose 2 |
Inclusion Criteria: 1. Males or females, age 18 to 65 years at Screening Visit, inclusive 2. Diagnosis of CF 3. ppFEV1 value between 50-100% (inclusive) 4. Resting oxygen saturation ≥94% on room air by pulse oximetry 5 . Clinically stable CF disease as assessed by the Investigator and not requiring...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | VX-121/TEZ/D-IVA |
| BiomX Inc. | 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 |