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Also known as doxorubicin
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...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-272, Tezacaftor |
| 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 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
SP-101 is an investigational small molecule being developed by Roivant Sciences Ltd. for the treatment of cystic fibrosis, a respiratory condition. It is in Phase 1 clinical development and has not been approved by the FDA. The program is being studied in a single active trial in the United States.
SP-101 is being studied as a treatment for cystic fibrosis, a genetic respiratory disease. The Phase 1/2 trial enrolls adults 18 years and older with cystic fibrosis in the United States. Because SP-101 remains investigational, it is not yet available as a marketed therapy for cystic fibrosis or any other condition.
SP-101 is being developed by Roivant Sciences Ltd., which trades on the Nasdaq under the ticker ROIV. Roivant is the sponsor of the SP-101 cystic fibrosis program. The company is advancing the small molecule through early-stage clinical testing, with one active trial currently recruiting participants.
SP-101 is in Phase 1 clinical development. Its only registered study is a Phase 1/2 trial in cystic fibrosis that is currently recruiting. SP-101 is investigational and has not received FDA approval. The trial is designed to enroll approximately 15 participants, all adults aged 18 years and older.
SP-101 is being evaluated in one clinical trial, NCT06526923, titled A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF). The study is recruiting in the United States with a planned enrollment of 15 participants. It is a controlled trial and is not randomized or double blinded.
SP-101 is also referred to as SP-101 and doxorubicin Cohort 1. That combined name reflects the trial cohort designation used in the SP-101 cystic fibrosis program. Readers searching for either term are looking at the same investigational small molecule developed by Roivant Sciences Ltd. for cystic fibrosis.