Pharvaris Reports Rapid Symptom Relief and Broad Efficacy for Deucrictibant in Landmark Phase 3 HAE Study
Key RAPIDe-3 Data Shows Median Symptom Relief Onset in 1.28 Hours—Much Faster Than Placebo
Pharvaris’ latest pivotal data could represent a step change for patients with hereditary angioedema (HAE). The RAPIDe-3 global Phase 3 trial found that the oral therapy deucrictibant delivers rapid, statistically significant relief during acute HAE attacks—marking a potentially major milestone in treatment options for this rare, unpredictable condition.
In the study, deucrictibant immediate-release capsules achieved a median time to onset of symptom relief in just 1.28 hours, dramatically outperforming placebo, which had a median time greater than 12 hours. The study enrolled 134 participants worldwide across various age groups, HAE subtypes, and attack severities—making it one of the most comprehensive and representative HAE trials to date.
Efficacy Consistent Across All HAE Subtypes and Attack Severities
What sets these results apart is not just the speed of symptom relief, but the consistent performance across patient groups. Deucrictibant’s efficacy was maintained among adolescents, adults, and people with all recognized HAE subtypes—including those with normal C1 inhibitor function. Every one of the study’s prespecified efficacy endpoints was met with statistical significance (p<0.0001), demonstrating robust, across-the-board effectiveness.
The median time to full symptom resolution with deucrictibant was 11.95 hours, compared to over 24 hours with placebo. Just as importantly, deucrictibant proved effective in a single dose for the vast majority of attacks, reducing the need for rescue medications or additional dosing within 12 hours of treatment.
| Key Endpoint | Deucrictibant | Placebo | Statistical Significance |
|---|---|---|---|
| Median Time to Symptom Relief | 1.28 hrs | >12 hrs | p<0.0001 |
| Median Time to End of Progression | 17.47 min | 228.67 min | p<0.0001 |
| Complete Symptom Resolution | 11.95 hrs | >24 hrs | p<0.0001 |
| Single Dose Efficacy (Attacks Treated) | 83.0% | N/A | — |
| No Rescue Medication Needed | 93.2% | N/A | — |
Well-Tolerated Safety Profile Reinforces Potential as a First-Line Option
Beyond efficacy, safety is always a crucial question—especially for a new oral therapy in a field where injectable treatments are the current standard. In the RAPIDe-3 study, deucrictibant was well tolerated with no treatment-related serious adverse events and no discontinuations due to treatment-emergent side effects. The safety profile remains consistent with earlier studies and showed no new signals, according to Pharvaris.
Regulatory Path: Next Steps Could Bring First Oral, On-Demand HAE Therapy
Pharvaris plans to submit a New Drug Application (NDA) to the U.S. FDA in the first half of 2026. If approved, deucrictibant could be the first and only oral therapy capable of addressing both on-demand and prophylactic HAE treatment needs—potentially simplifying patient management and offering new flexibility in care.
Further insights—including more data from ongoing open-label and extension studies—will be presented at upcoming medical meetings. Meanwhile, Pharvaris’ global Phase 3 CHAPTER-3 trial for prophylactic treatment and the CREAATE trial for acquired angioedema (AAE-C1INH) continue, underscoring the company’s broad ambition in bradykinin-mediated angioedema therapies.
Key Takeaway: New Hope for HAE Patients Awaiting More Convenient, Effective Relief
The results of RAPIDe-3 highlight the potential of deucrictibant to set a new benchmark for speed and convenience in on-demand HAE treatment. Investors and patients alike will be watching for regulatory progress—and for upcoming trial data that could further confirm deucrictibant’s promise as an oral, easy-to-administer option in a space historically dominated by injectables. With an NDA planned for 2026 and more data forthcoming, the spotlight on Pharvaris is just beginning to intensify.
Contact Information:
If you have feedback or concerns about the content, please feel free to reach out to us via email at support@marketchameleon.com.
About the Publisher - Marketchameleon.com:
Marketchameleon is a comprehensive financial research and analysis website specializing in stock and options markets. We leverage extensive data, models, and analytics to provide valuable insights into these markets. Our primary goal is to assist traders in identifying potential market developments and assessing potential risks and rewards.
NOTE: Stock and option trading involves risk that may not be suitable for all investors. Examples contained within this report are simulated and may have limitations. Average returns and occurrences are calculated from snapshots of market mid-point prices and were not actually executed, so they do not reflect actual trades, fees, or execution costs. This report is for informational purposes only, and is not intended to be a recommendation to buy or sell any security. Neither Market Chameleon nor any other party makes warranties regarding results from its usage. Past performance does not guarantee future results. Please consult a financial advisor before executing any trades. You can read more about option risks and characteristics at theocc.com.
The information is provided for informational purposes only and should not be construed as investment advice. All stock price information is provided and transmitted as received from independent third-party data sources. The Information should only be used as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments and trading strategies. The Company does not guarantee the accuracy, completeness or timeliness of the Information.
Disclosure: This article was generated with the assistance of AI