Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Summary
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opaganib to improve and/or stabilize the clinical status of the patient.
Timeline
- Start
- 2020-08-21
- Primary completion
- 2021-07-18
- Completion
- 2021-07-18
Outcome
Missed primary endpoint
registry analysis (superiority test); Opaganib vs Placebo; p = 0.391; Risk Difference (RD) 3.86 (95% CI -4.93 to 12.65) NCT04467840 ↗
release “opaganib (ABC294640)[1] in hospitalized patients with severe COVID-19 pneumonia. Preliminary top-line data showed that the study did not meet its primary endpoint.” redhillbio.com ↗
release “COVID-19 pneumonia (NCT04467840). Whilst results showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.” redhillbio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ABC294640 | Small molecule | 500 mg | Oral |