Rapport Therapeutics, Inc. (NASDAQ:RAPP) stock traded higher on Monday, with a session volume of 3.20 million compared to the average volume of 179.3 thousand, according to data from Benzinga Pro.
On Monday, the company revealed data from the Phase 2a trial of RAP-219 (RAP-219-FOS-201) in patients with drug-resistant focal onset seizures.
The study met its primary endpoint, demonstrating a statistically significant reduction in long episodes (LEs) – an objective electrographic biomarker for clinical seizure reduction – compared with baseline over the 8-week treatment period.
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In the trial, RAP-219 also demonstrated a statistically significant and clinically meaningful reduction in clinical seizures compared with baseline. RAP-219 was generally well tolerated.
Patients received 0.75 mg RAP-219 oral tablet daily for 5 days, followed by 1.25 mg RAP-219 oral tablet daily for the remainder of the 8-week treatment period.
Key Efficacy Results:
Efficacy findings from the Phase 2a trial achieved statistically significant results for primary LE endpoints and key secondary endpoints of clinical seizures.
In the 8-week treatment period, 85.2% of patients achieved ≥30% reduction in LEs from baseline, 72.0% achieved ≥50% reduction in clinical seizures from baseline, and 24% of patients achieved seizure freedom.
RAP-219 was generally well-tolerated in the trial, with the majority of treatment-emergent adverse events (TEAEs) being mild and a low discontinuation rate.
All TEAEs reported were mild (78.5%) or moderate (21.5%) in severity (Grades 1 or 2).
Next Steps
The company plans to advance RAP-219 into two Phase 3 pivotal trials using traditional clinical seizure endpoints in the third quarter of 2026.
Rapport plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025.
The company also expects to present additional efficacy analyses and 8-week follow-up results in 2026.
Additional RAP-219 Development Plans
By the end of 2025, Rapport plans to initiate an open-label long-term safety trial to allow patients enrolled in the RAP-219-FOS-201 trial to continue on RAP-219. Preliminary results of the trial are expected in the second half of 2026.
Additionally, Rapport continues development of a long-acting injectable (LAI) formulation of RAP-219. The company believes a LAI formulation has the potential to improve patient adherence and expand the potential clinical utility across all of RAP-219’s indications.
Outside of epilepsy, Rapport is evaluating RAP-219 in a Phase 2 trial in bipolar mania. The trial is currently enrolling patients and is on track, with topline results expected in the first half of 2027. An update on the plan and timeline for initiation of a Phase 2 trial in diabetic peripheral neuropathic pain is expected later in 2025.
Price Action: At the last check on Monday, RAPP stock was up 210.52% at $44.59 during the premarket session.
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