Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Opaganib · 2 trials · 3 indications
To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.
Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
| Arm | Type | Description |
|---|---|---|
| Opaganib | EXPERIMENTAL | In addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube. |
| Placebo | PLACEBO_COMPARATOR | In addition to standard of care, a matching placebo will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. Where required this may be made into a suspension form and may be administered by nasogastric tube. |
| Name | Type | Description |
|---|---|---|
| Opaganib | DRUG | Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). |
| Placebo | DRUG | Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14). |
Inclusion Criteria: 1. Adult male or female ≥18 to ≤80 years of age 2. Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan. that diagnosed COVID-19 pneumonia. Pharyngeal samples...
Opaganib is an investigational small molecule being studied for the treatment of coronavirus infections, including COVID-19 pneumonia. It has been evaluated in clinical trials for patients with COVID-19 and related lung infections. The drug is not approved and remains in clinical development.
Opaganib is a sphingosine kinase-2 (SK2) inhibitor. It works by inhibiting the SK2 enzyme, which is involved in cellular signaling pathways. This mechanism is being studied for its potential effects in treating COVID-19 pneumonia and other coronavirus infections.
Opaganib is being developed by Redhill Biopharma Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol RDHL. Redhill Biopharma is conducting clinical trials to evaluate the safety and efficacy of Opaganib for COVID-19 and related conditions.
Opaganib is in Phase 2 clinical development. It has completed two Phase 2 trials for COVID-19 pneumonia and coronavirus infections. The drug is investigational and has not received FDA approval. It has been granted orphan drug and rare pediatric disease designations by the FDA.
Opaganib has been studied in two completed Phase 2 clinical trials. The first trial, NCT04414618, enrolled 42 participants with coronavirus infections in the United States and Israel. The second trial, NCT04467840, enrolled 475 participants with COVID-19 pneumonia across multiple countries including the United States, Brazil, and Italy.
Opaganib is also known by its chemical name and is not commonly referred to by alternative brand names. It is a sphingosine kinase-2 inhibitor being developed by Redhill Biopharma. No other alternative names have been established for this investigational drug in clinical development.