PHVS Study Shows Deucrictibant Cuts HAE Attack Relief Time to Just 1.28 Hours: Phase 3 Results Impress
Key Findings: Fast, Consistent, and Broadly Effective Relief
Pharvaris (NASDAQ: PHVS) unveiled pivotal Phase 3 results this morning, and the numbers behind deucrictibant’s performance for hereditary angioedema (HAE) attacks are hard to ignore. In the RAPIDe-3 study, deucrictibant, an oral bradykinin B2 receptor antagonist, achieved the primary endpoint, delivering symptom relief in a median time of just 1.28 hours versus more than 12 hours with placebo (p<0.0001). All 11 secondary efficacy endpoints were also met with high statistical significance, setting a new benchmark for oral HAE treatments.
Fast Relief and Robust Outcomes: Key Efficacy Metrics
Participants experienced rapid improvement across all measured aspects of their HAE attacks, as detailed in the RAPIDe-3 trial:
| Outcome | Deucrictibant (IR Capsule 20mg) | Placebo |
|---|---|---|
| Median Time to Onset of Symptom Relief | 1.28 hours | >12 hours |
| Median Time to End of Progression | 17.47 minutes | 228.67 minutes |
| Median Time to Substantial Symptom Relief (PGI-C “better”) | 2.85 hours | >12 hours |
| Median Time to Complete Symptom Resolution | 11.95 hours | >24 hours |
| Single Capsule Treated Attacks | 83.00% | - |
| No Rescue Medication Needed | 93.20% | - |
What’s notable is how this efficacy held across patient types—including those with HAE type 1, type 2, or normal C1 inhibitor—and across all severities and locations of attacks. That breadth adds credibility to deucrictibant’s potential as a go-to, on-demand oral treatment for a diverse HAE population.
Safety Profile Remains Strong and Consistent
Deucrictibant not only worked quickly but also maintained a favorable safety profile. No treatment-related serious adverse events were reported, and no participants discontinued due to treatment-emergent adverse events. Safety outcomes in this Phase 3 trial align with previous Phase 2 data, and an ongoing extension study is set to track long-term results.
Market Implications: Regulatory Pathway and Broader Impact
Pharvaris intends to submit marketing authorization applications for deucrictibant beginning in the first half of 2026, positioning the company for potential regulatory approval in a space with significant unmet need. If a second pivotal study (CHAPTER-3) meets its endpoints, deucrictibant could become the first and only oral therapy addressing both acute and prophylactic HAE treatment. For patients, the ability to control HAE attacks with a single, well-tolerated oral dose would be a notable advancement over existing options.
Takeaway: What’s Next for PHVS and Deucrictibant?
For investors and those tracking biopharma innovation, these RAPIDe-3 results give Pharvaris significant momentum. With a proven efficacy and safety profile, as well as regulatory filings on the horizon, deucrictibant may reshape standards for HAE attack management if the ongoing extension and prophylactic studies echo these findings. The next inflection points: upcoming conference data presentations, progress in ongoing trials, and the NDA submission targeted for the first half of 2026. The door appears wide open for this promising therapy to fill longstanding treatment gaps for HAE patients globally.
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