Pharvaris Presents Long-Term Deucrictibant Data for HAE at Bradykinin Symposium 2024

Pharvaris, a late-stage biopharmaceutical company, is presenting new data on deucrictibant at the Bradykinin Symposium 2024 in Berlin. Deucrictibant is an oral bradykinin B2 receptor antagonist aimed at preventing and treating hereditary angioedema (HAE) attacks. The long-term data from both prophylactic and on-demand settings highlights its potential as a preferred treatment for HAE.

In the prophylactic extension study, deucrictibant demonstrated a 93% reduction in attack rates compared to baseline, maintaining a median attack-free rate for over a year. Participants experienced a 99% mean proportion of attack-free days. These findings align with earlier data from the CHAPTER-1 study, which indicated significant improvements in disease control and quality of life.

The on-demand data for deucrictibant immediate-release capsules is equally promising. The median onset of symptom relief was around 1.1 hours, with 85.8% of attacks resolving within 24 hours. This rapid relief places deucrictibant as a competitive option against existing treatments.

Dr. Peng Lu, Chief Medical Officer of Pharvaris, emphasized the long-term efficacy and tolerability of deucrictibant in both settings. The safety profile has been consistently reaffirmed across multiple studies. The findings suggest deucrictibant could significantly improve the quality of life for people with HAE by providing more effective and convenient treatment options.

Marc A. Riedl, a leading clinical expert, underscored the importance of effective HAE management to allow individuals to live normal lives. He noted that therapies like deucrictibant, which offer enhanced efficacy and convenience, are crucial for normalizing the lives of HAE patients. The long-term data supports deucrictibant's potential as a viable treatment option.

The CHAPTER-1 study is a two-part Phase 2 trial evaluating deucrictibant's efficacy and safety for long-term prophylaxis of HAE attacks. Initial results from the double-blind, placebo-controlled part of the study were positive, with 90% of participants reporting well-controlled HAE at 12 weeks compared to 37.5% in the placebo group. Participants also reported greater satisfaction with the treatment’s effectiveness and overall satisfaction.

All eligible participants from the first part of the CHAPTER-1 study enrolled in an ongoing open-label extension, receiving 40 mg/day of deucrictibant for an average of 12.83 months. Results show a 93% reduction in attack rates compared to the baseline of the initial study phase. The occurrence of moderate to severe attacks and the need for on-demand medication remained low.

In the on-demand program, the RAPIDe-2 study evaluates the long-term safety and efficacy of deucrictibant immediate-release capsules. The safety analysis, covering 337 attacks, showed that deucrictibant was well-tolerated at all studied doses. The efficacy analysis, including 265 attacks, revealed a median onset of symptom relief in 1.1 hours, with nearly all attacks achieving relief within 12 hours. Complete attack resolution was achieved within 24 hours for 85.8% of attacks.

A comparison with the standard of care treatments in a propensity-score matched analysis showed more favorable outcomes for deucrictibant in the RAPIDe-2 study, further highlighting its potential advantages.

Dr. Nieves Crespo presented data on the cardiovascular safety of deucrictibant, indicating no adverse impact on cardiovascular parameters in both nonclinical and clinical studies. This comprehensive safety profile supports the long-term use of deucrictibant in HAE management.

Pharvaris continues to develop deucrictibant, with plans to initiate pivotal Phase 3 studies for both prophylactic and on-demand treatments in the coming months. The promising data from Phase 2 studies provide a solid foundation for these future trials, aiming to offer an effective and well-tolerated treatment option for HAE patients.

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