Rapport Therapeutics RAP-219 双相躁狂 Phase 2 达到主要与次要终点，但盘前冲高84%后大幅回落

On Tuesday, Rapport Therapeutics Inc. (RAPP) announced positive topline results from its Phase 2 trial of RAP-219 in adults with acute bipolar mania, meeting the primary and secondary endpoints and supporting the drug's advancement into Phase 3 development.
Bipolar disorder is a mental health condition characterized by episodes of depression and mania, which can involve elevated mood, increased energy, irritability, and reduced need for sleep.
RAP-219 is an investigational, potentially first-in-class TARP Gamma-8-selective AMPA receptor negative allosteric modulator designed to selectively target neural signaling pathways.
The randomized, double-blind, placebo-controlled Phase 2 trial enrolled 253 adults with bipolar I disorder experiencing an acute manic episode. Patients received RAP-219 at 0.75 mg once daily or placebo for three weeks in an inpatient setting.
The trial met its primary endpoint, with RAP-219 demonstrating a 3.1-point placebo-adjusted improvement in the Young Mania Rating Scale (YMRS) total score at Week 3.
The mean reduction from baseline was 15.4 points with RAP-219, compared with 12.3 points with placebo at week 3. Improvement progressed over the treatment period, with placebo-adjusted reductions of 0.9, 2.2, and 3.1 points at Weeks 1, 2 and 3, respectively.
The drug also met the prespecified secondary endpoint, demonstrating a 0.4-point improvement over placebo in the Clinical Global Impression-Bipolar Version (CGI-BP) mania severity score at Week 3.
All 11 YMRS symptom items improved numerically compared with placebo, with irritability, thought content, disruptive-aggressive behavior, and sexual interest showing nominally significant improvements.
RAP-219 was generally well tolerated. Treatment-emergent adverse events occurred in 51.6% of patients receiving RAP-219 and 52.8% of those receiving placebo, while psychiatric adverse events occurred in 34.9% and 33.1%, respectively.
All adverse events were mild or moderate, with no serious adverse events reported during the three-week treatment period. Discontinuations due to adverse events occurred in 3.2% of RAP-219-treated patients versus 0.8% of placebo recipients. The most common adverse events with RAP-219 were agitation, insomnia, restlessness, anxiety, headache, and nausea. Somnolence occurred in 0.8% of RAP-219-treated patients versus 3.1% of placebo recipients.
Upcoming Milestones
Rapport plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2027 to discuss the Phase 2 results and registrational trial design, with two Phase 3 trials expected to begin in the second half of 2027. Additional safety data from the eight-week post-treatment period of the bipolar mania trial will be presented at a future medical conference.
Rapport expects initial data from the long-term open-label extension of its Phase 2a focal onset seizure (FOS) trial in the fourth quarter of 2026. The company is enrolling patients in its pivotal Phase 3 FOCUS 1 and FOCUS 2 trials for FOS and expects to initiate a Phase 3 trial in primary generalized tonic-clonic seizures (PGTCS) in the first half of 2027.
Phase 1 pharmacokinetic data for a long-acting injectable formulation of RAP-219 are expected in the third quarter of 2027, while preliminary Phase 1 results for RAP-641 are anticipated in the second half of 2027.
Financial Position
As of June 30, 2026, Rapport had $436.1 million in cash, cash equivalents and short-term investments, excluding restricted cash. The company expects its cash position to fund operations into the second half of 2029, beyond anticipated topline results from its Phase 3 FOS program.
RAPP closed on Monday at $28.60, up 3.74%.
In the premarket, shares rose 33.81% to $38.27.
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