Pharvaris N.V. · NASDAQ:PHVS

Pharvaris — Technical Presentation (2026)

14 slides from Pharvaris's technical presentation, 2026

  1. Slide 1: On-Demand Treatment of HAE Attacks With Oral Deucrictibant IR Capsule: RAPIDe-3 Results

    On-Demand Treatment of Hereditary Angioedema Attacks With Oral Deucrictibant Immediate-Release Capsule: Efficacy and Safety Results of the Phase 3 RAPIDe-3 Trial Joshua S. Jacobs1, Marc A. Riedl2, Philip H. Li3, Adil Adatia4, Mauro Cancian5, Marcin Stobiecki6, Anna Valerieva7, Anete S. Grumach8, Wil

  2. Slide 2: Author disclosures

    Author disclosures COI: J.S.J.: BioCryst, CSL Behring, Cycle Pharma, Intellia, Ionis, KalVista, Pharming, Pharvaris, Takeda; M.A.R.: Astria, BioCryst, BioMarin, Celldex, CSL Behring, Cycle Pharma, Grifols, Intellia, Ionis, KalVista, Novartis, Pharming, Pharvaris, Sanofi-Regeneron, Takeda; P.H.L.: As

  3. Slide 3: Background and Objective

    Background  Hereditary angioedema (HAE): a bradykinin-mediated condition with painful swelling attacks affecting multiple locations in the body. 1  Unmet need: an unmet need remains for additional orally administered treatments combining ease of administration, rapid and sustained effects, and a w

  4. Slide 4: RAPIDe-3 trial design

    RAPIDe-3 trial design Double-blind crossover treatment with 2 qualifying attack treatment periods Placebo Deucrictibant IR 20 mg End-of-study visitb Screening Day 1 after second HAE Rollover and ePRO R visit a attack treated with to OLE training Deucrictibant IR 20 mg Placebo study drug Post-attack

  5. Slide 5: Selected efficacy and safety endpoints

    Selected efficacy and safety endpoints a Endpoint Instrument Definition Primary endpoint Time to a PGI-C rating of at least “a little better” for 2 consecutive timepoints within Time to onset of symptom relief PGI-C 12 hours post-treatment Secondary endpoints Proportion of study-drug treated attacks

  6. Slide 6: Results

    Results  A total of 134 eligible participants (10 [7.5%] adolescents, 4 [3.0%] with HAE-nC1INH) were enrolled and randomized at 59 sites across 24 countries on 6 continents.  The primary efficacy analysis set included 88 participants with paired attacks, and 113 participants had ≥1 attack treated

  7. Slide 7: Participant demographics and baseline disease characteristics

    Participant demographics and baseline disease characteristics Participant characteristics All randomized participants (N=134) Age in years, mean (SD) 39.0 (14.7) ≥12 to <18, n (%) 10 (7.5) ≥18 to <65, n (%) 116 (86.6) ≥65, n (%) 8 (6.0) Sex: Female, n (%) 76 (56.7) BMI, mean (SD) 26.5 (5.9) Race, n

  8. Slide 8: Primary endpoint: Significantly faster onset of symptom relief with deucrictibant

    Primary endpoint: Significantly faster onset of symptom relief with deucrictibant compared with placebo a,b 100% 90% 80% Proportion of attacks achieving onset of symptom relief 70% 1.28 hours >12 hours 60% (95% CI: 1.05, 1.52) (95% CI: 5.82, >12) 50% 40% 30% P<0.0001 Deucrictibant 20% Placebo 10% Ce

  9. Slide 9: Secondary endpoints (1/2)

    Secondary endpoints (1/2) End of progression in attack symptoms a,b Substantial symptom relief a,c 100% 100% 90% 90% 2.85 hours end of progression in attack symptoms 80% 80% (95% CI: 2.08, 3.35) Proportion of attacks achieving Proportion of attacks achieving substantial symptom relief 70% 17.47 minu

  10. Slide 10: Secondary endpoints (2/2)

    Secondary endpoints (2/2) Reduction in attack severity a,d Complete symptom resolutiona,e 100% 100% 90% 90% 2.41 hours 80% (95% CI: 1.70, 2.98) 80% 11.95 hours Proportion of attacks achieving Proportion of attacks achieving complete symptom resolution reduction in attack severity 70% 70% (95% CI: 8.

  11. Slide 11: Proportion of attacks achieving efficacy endpoints within pre-specified timeframes

    Proportion of attacks achieving efficacy endpoints within pre-specified timeframes Onset of symptom relief Substantial symptom relief Reduction in attack severity Complete symptom resolution by 12 hoursa,b by 12 hoursa,c by 12 hours a,d at 48 hours a,e 90.4% 85.5% 85.5% 81.9% (n=75/83 ) f (n=71/83 )

  12. Slide 12: Lower proportion of attacks treated with a second dose or rescue medication

    Lower proportion of attacks treated with a second dose or rescue medication with deucrictibant compared with placebo Deucrictibant (N=88) Placebo (N=88) 100% 80% Proportion of attacks 67.0% 60% 40% 36.4% 20% 17.0% 6.8% 0% Second dose of study drug Rescue medication use within 12 hours use within 12

  13. Slide 13: Adverse events occurring within 3 days post-treatment

    Adverse events occurring within 3 days post-treatment  One event was reported on more than one occasion within 3 days post-treatment. A single event of fatigue occurred in 2 participants in the deucrictibant group within 3 days of study drug administration, one of which was deemed unrelated to trea

  14. Slide 14: Key takeaways

    Key takeaways Results from the pivotal RAPIDe-3 trial for treatment of attacks in multiple types of hereditary angioedema provide further evidence on the rapid and sustained efficacy, safety, and tolerability of the orally administered bradykinin B2 receptor antagonist deucrictibant immediate-releas

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