Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REM-422 · 1 trial · 4 indications
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and number of participants with Dose Limiting Toxicities will be assessed to determine Safety and Tolerability of REM-422 from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and the number of participants with Dose Limiting Toxicities will be assessed from the date of first dose of REM-422 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months
| Arm | Type | Description |
|---|---|---|
| REM-422 | EXPERIMENTAL | Dose Escalation: Participants will receive escalating doses of REM-422 to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)-422, oral capsule administered once daily Dose Expansion: Participants will receive REM-422 at the identified RP2D Treatment will continue until disease progression, therapy intolerance, or participant withdrawal Safety evaluation will continue until 30 days of last administration of REM-422 |
| Name | Type | Description |
|---|---|---|
| REM-422 | DRUG | REM-422 is a first in class, small molecule mRNA inhibitor that reduces expression of the MYB transcription factor REM-422 will be administered orally once daily |
Inclusion Criteria: 1. Be able to provide informed consent. 2. Be 18 or older at the time of informed consent. 3. Disease criteria: Histologically confirmed diagnosis of either: 1. R/R AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or ...
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REM-422 is an investigational small molecule being developed for the treatment of Myelodysplastic Syndromes (MDS), specifically higher risk MDS, as well as Acute Myeloid Leukemia (AML) and refractory AML. It is currently in Phase 1 clinical development for these oncology indications.
REM-422 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is currently in Phase 1 clinical trials for the treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia.
REM-422 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug in patients with AML or higher risk MDS.
REM-422 is being studied in a Phase 1 clinical trial with the identifier NCT06297941, titled "Study of REM-422 in Patients With AML or Higher Risk MDS." This trial is currently recruiting and aims to enroll approximately 100 participants in the United States and France.
REM-422 is a small molecule being developed for the treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia. The clinical trial for REM-422 uses biomarker-selected patient populations, indicating that the drug may target specific molecular characteristics, though the specific molecular target has not been disclosed.