Rapport Reveals Promising Phase 2a Data for RAP-219 Epilepsy Pill, Plans Phase 3 Trials

Rapport Therapeutics announced positive topline results from a Phase 2a trial of RAP-219 in patients with drug-resistant focal onset seizures.

The study showed a 77.8% median reduction in clinical seizure frequency over an 8-week treatment period, with 24% of participants achieving complete seizure freedom3514.

The primary endpoint was met:
85.2% of patients achieved ≥30% reduction in prolonged episodes, a biomarker for seizure frequency514.

RAP-219 was generally well-tolerated, with mostly mild adverse events and no serious side effects reported51.

The study included 30 drug-resistant epilepsy patients who were typically taking three other antiseizure medications41.

Based on these results, Rapport plans to advance RAP-219 into two Phase 3 pivotal trials in the third quarter of 2026, pending an FDA end-of-Phase 2 meeting in late 202515.

This trial was the first to test a novel antiseizure medication in focal epilepsy patients using the implanted RNS system as an objective seizure biomarker1.

Expert commentary noted that the clinical benefit and biomarker evidence set a new precedent for open-label epilepsy studies and suggested RAP-219 could be a top-selling anti-seizure medicine for drug-resistant focal seizure patients1.

A long-acting injectable formulation is also in development to improve patient adherence5.

Sources:

1. https://www.biospace.com/drug-development/rapport-jumps-180-on-best-case-mid-stage-data-for-epilepsy-pill

3. https://www.statnews.com/2025/09/08/rapport-rap219-focal-seizures-epilepsy-trial-results/

4. https://www.fiercebiotech.com/biotech/rapports-seizure-drug-hits-phase-2-sending-stock-soaring

5. https://www.stocktitan.net/news/RAPP/rapport-announces-positive-topline-results-from-phase-2a-clinical-hpnzswrskqsl.html