Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JBI-802 · 1 trial · 3 indications
Number of participants with dose-limiting toxicity (DLT) events during the DLT monitoring period. DLTs are defined per protocol criteria and graded using NCI CTCAE Version 5.0. Units: Number of participants
Percentage of participants with best overall response of complete response or partial response according to MPN IWG-MRT or MDS/MPN IWG criteria. Units: Percentage of participants
Percentage of participants achieving complete remission per IWG criteria. Units: Percentage of participants
Time from first dose to disease progression or death from any cause. Units: Months
Time from first dose to death from any cause. Units: Months
Number of participants achieving platelet count ≤400 ×10⁹/L in absence of thromboembolic events. Units: Number of participants
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: Escalating oral dose of JBI-802 | EXPERIMENTAL | JBI-802 - CoREST inhibitor (Dual LSD1 and HDAC6 inhibitor) |
| Dose Expansion: Expansion arm at the RP2D of oral JBI-802 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| JBI-802 | DRUG | CoREST inhibitor dual targeting LSD1 and HDAC6 |
Inclusion Criteria: \- Male or female subjects aged ≥18 years at the time of screening visit. For Dose Escalation Phase: Subjects diagnosed with any one of the following: * Subject with diagnosis of Essential Thrombocythemia (ET) per World Health Organization (WHO) diagnostic criteria for myelop...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Bomedemstat, Hydroxyurea |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB057643, Ruxolitinib |
JBI-802 is an investigational small molecule being developed for the treatment of Essential Thrombocythemia (ET), a type of myeloproliferative neoplasm. It is also being studied in related conditions such as Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis. The drug is administered orally and is currently in Phase 1 clinical development.
JBI-802 is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for the treatment of myeloproliferative neoplasms, including Essential Thrombocythemia.
JBI-802 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy. The ongoing Phase 1/Phase 2 study is recruiting participants to evaluate the drug in patients with myeloproliferative neoplasms.
JBI-802 is being studied in a Phase 1/Phase 2 clinical trial with the identifier NCT07612280. This trial is assessing the safety and efficacy of orally administered JBI-802 in subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis. The study is currently recruiting participants in Australia and has a target enrollment of 30 patients.
JBI-802 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing clinical trial is designed to evaluate its safety and efficacy, but the drug has not yet received regulatory approval for the treatment of Essential Thrombocythemia or any other condition.