Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Yeliva, ABC294640
Opaganib · 3 trials · 8 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.
To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640.
To determine the Durable Disease Control Rate (DDCR) of CCA defined as Disease Control Rate (DCR) of at least 4 months duration to treatment with ABC294640 and HCQ
| 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. |
| ABC294640 +/- HCQ treatment | EXPERIMENTAL | Part 1: All participants will be receiving ABC294640, 500 mg twice a day (BID), continuously in 28 day cycles Part 2: All participants will be receiving ABC294640, 500 mg twice a day (BID) and HCQ at a determined level, continuously in 28 day cycles |
| 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). |
| ABC294640 | DRUG | Two 250 mg capsules of ABC294640 will be taken twice daily |
| Hydroxychloroquine Sulfate 200 MG | DRUG | HCQ tablets will be taken at a dose that will be determined |
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...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Opaganib is an investigational small molecule being studied for the treatment of COVID-19 and coronavirus infections, specifically COVID-19 pneumonia. It has been evaluated in Phase 2 clinical trials in adults aged 18 and older. It is not approved for any indication and remains in clinical development.
Opaganib targets sphingosine kinase-2 (SK2), a kinase enzyme. It belongs to the -nib kinase inhibitor class. By inhibiting SK2, opaganib is designed to interfere with sphingolipid signaling pathways relevant to viral infection and inflammation in COVID-19 pneumonia.
Opaganib is being developed by RedHill Biopharma Ltd., which trades under the ticker RDHL. The company is the sponsor of the clinical trials evaluating opaganib in COVID-19 and coronavirus infections.
Opaganib is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. The completed Phase 2 trials were randomized, double-blind, and placebo-controlled, evaluating the drug in adults with COVID-19 pneumonia.
Opaganib has been studied in two completed Phase 2 trials. NCT04467840 evaluated opaganib as a sphingosine kinase-2 inhibitor in COVID-19 pneumonia across multiple countries with 475 participants. NCT04414618 studied opaganib in coronavirus disease 2019 pneumonia in the United States and Israel with 42 participants.