Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RAP-219 · 5 trials · 8 indications
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates
The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.
Change in long episode frequency per 28-day period during the treatment period compared to baseline
| Arm | Type | Description |
|---|---|---|
| Active Arm- Medium Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Active Arm-Low Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| Placebo | PLACEBO_COMPARATOR | Inert comparator matching the active treatment |
| Active Arm- High Dose | EXPERIMENTAL | RAP-219 daily tablets administered orally |
| RAP-219 | EXPERIMENTAL | - |
| Active Arm | EXPERIMENTAL | Treatment with RAP-219 |
| Name | Type | Description |
|---|---|---|
| RAP-219 | DRUG | RAP-219 medium dose tablets administered orally daily |
| Placebo | OTHER | Matching placebo tablets administered orally |
Inclusion Criteria: 1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis 5. Concomitant use of betwee...
RAP-219 is an investigational small molecule being developed by Rapport Therapeutics, Inc. for focal epilepsy, focal onset seizures, and bipolar 1 disorder. It is given as an oral treatment and is currently in clinical development, with Phase 3 studies ongoing in focal seizures and Phase 2 studies in focal onset seizures and bipolar 1 disorder.
RAP-219 is being studied for focal epilepsy and focal onset seizures in adults, including refractory focal epilepsy. It is also in development for bipolar 1 disorder. The focal seizure program has advanced to Phase 3, while the long-term focal onset seizure study and the bipolar 1 disorder study are Phase 2.
RAP-219 targets RAP, a receptor-associated protein that helps localize AMPA receptors to the neuronal surface. By binding RAP, RAP-219 is designed to selectively reduce AMPA receptor signaling in the brain regions involved in focal seizures and mood disorders, rather than broadly blocking AMPA receptors throughout the nervous system.
RAP-219 is being developed by Rapport Therapeutics, Inc., a clinical-stage biopharmaceutical company that trades on the Nasdaq under the ticker RAPP. Rapport is the sponsor of the RAP-219 clinical program, which includes Phase 3 studies in focal seizures and Phase 2 studies in focal onset seizures and bipolar 1 disorder.
RAP-219 is in Phase 3 development for focal seizures and Phase 2 development for focal onset seizures and bipolar 1 disorder. It is investigational and has not been approved by the FDA. The Phase 3 focal seizure program includes two randomized, double-blind, placebo-controlled studies, and a Phase 2 long-term safety study is also enrolling.
RAP-219 is being evaluated in four registered studies. Two Phase 3 trials, NCT07594119 and NCT07563881 (FOCUS-1), are recruiting adults with focal seizures in the United States and South Korea. NCT07219407 is a Phase 2 long-term focal onset seizure study, and NCT07046494 is a Phase 2 bipolar 1 disorder study that is active but not recruiting.