Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as yeliva, opaganib
ABC294640 · 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...
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ABC294640 is an investigational small molecule being studied for the treatment of cholangiocarcinoma, a cancer of the bile ducts. It has been evaluated in advanced cholangiocarcinoma, including non-resectable, perihilar, extrahepatic, and intrahepatic forms of the disease. It is not approved and remains in clinical development.
ABC294640 targets sphingosine kinase 2, or SPHK2, and acts as an inhibitor of that enzyme. SPHK2 is the molecular target of the drug. By inhibiting SPHK2, ABC294640 is designed to interfere with sphingolipid signaling pathways relevant to cancer cell survival and proliferation in cholangiocarcinoma.
ABC294640 is being developed by Redhill Biopharma Ltd., which trades under the ticker RDHL. The company is the sponsor of the clinical program evaluating the drug in cholangiocarcinoma. Redhill Biopharma is the developer associated with this asset.
ABC294640 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program has evaluated the drug in patients with advanced cholangiocarcinoma. Development stage information reflects a Phase 2 trial that has been completed.
ABC294640 has been studied in the Phase 2 trial NCT03377179, titled A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma. That trial enrolled 65 participants in the United States and is completed. It was an uncontrolled study without randomization or double blinding.
No. The ABC294640 cholangiocarcinoma trial NCT03377179 did not use biomarker selection to enroll patients. Participants were enrolled based on their disease rather than a predefined molecular biomarker. The study enrolled 65 patients with advanced cholangiocarcinoma, including intrahepatic, extrahepatic, perihilar, and non-resectable forms.