Pharvaris N.v. · NASDAQ:PHVS

Pharvaris — Technical Presentation (2025)

12 slides from Pharvaris's technical presentation, 2025

  1. Slide 1: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in HAE: CHAPTER-1 OLE

    Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: Data Snapshot Results of the CHAPTER-1 Open-Label Extension Study Marc A. Riedl1, John Anderson2, Francesco Arcoleo3, Mauro Cancian4, Hugo Chapdelaine5, Niall Conlon6, Efrem Eren7, Mark Gompels8, Sofia Grig

  2. Slide 2: Author disclosures

    Author disclosures M.A.R.: Astria, BioCryst, BioMarin, Celldex, CSL Behring, Cycle Pharma, Grifols, Intellia, Ionis, KalVista, Novartis, Pharming, Pharvaris, Sanofi- Regeneron, Takeda; J.A.: BioCryst, BioMarin, CSL Behring, Cycle Pharma, KalVista, Pharming, Pharvaris, Takeda; F.A.: CSL Behring, Take

  3. Slide 3: Background

    Background  Hereditary angioedema (HAE): Bradykinin-mediated condition with painful swelling attacks affecting multiple locations in the body. 1  Unmet need: Prophylactic treatments combining injectable-like efficacy, a well-tolerated profile, and ease of administration. 2-5  Oral deucrictibant:

  4. Slide 4: CHAPTER-1 study design

    CHAPTER-1 study design Part 1 (RCT): Double-blind Part 2 (OLE): Open-label treatment period (12 weeks) treatment period Placebo Deucrictibant 40 mg/day b End-of-study Screening R Deucrictibant 20 mg/day a (n=30) visit Deucrictibant 40 mg/day b  Part 1 randomized placebo-controlled trial (RCT): Comp

  5. Slide 5: Participants and safety outcomes in the OLE

    Participants and safety outcomes in the OLE  At data cutoff (10 June 2024), 30 participants in the OLE had received deucrictibant 40 mg/day for a mean (SD) treatment duration of 12.83 (5.03) months; 5 participants had discontinued, 25 were ongoing.  Maximum exposure to deucrictibant: 20.8 months i

  6. Slide 6: Attack rate reduced in the RCT and remained low in the OLE

    Attack rate reduced in the RCT and remained low in the OLE  RCT: Deucrictibant reduced the attack rate, with effects observed within the first month.  OLE: Low attack rate maintained through ≥1.5 years. 4 RCT OLE Placebo RCT 20 mg/day RCT c Attack rate (mean ± SEM) 40 mg/day RCT d 3 40 mg/day OLE

  7. Slide 7: Attack rate in OLE compared to study baseline

    Attack rate reduced in the OLE compared to study baseline 2.5 2.18 2.0 Attack rate (mean) 93.1% 1.5 reduction a 1.0 0.5 0.15 0.0 Attack rate/month (Part 1) Attack rate/month (OLE) Study baselineb OLE 40 mg/day c (N=30) (N=30) IR, immediate release; LS, least squares; OLE, open-label extension. N = n

  8. Slide 8: Moderate and severe attack rate reduced in RCT and remained low in OLE

    “Moderate and severe” attack rate reduced in the RCT and remained low in the OLE RCT OLE P=0.0068a 2 P=0.0066a Attack rate (LS mean) 1.51 1.5 83.1% reduction 1 92.4% b reduction 0.5 0.26 0.12 0.07 0 Placebo/40 mg/day 20 mg/day/ 40 mg/day 40 mg/day/ 40 mg/day OLE overall Placebo 20 mg/day c 40 mg/day

  9. Slide 9: On-demand–treated attack rate reduced in RCT and remained low in OLE

    On-demand–treated attack rate reduced in the RCT and remained low in the OLE RCT OLE P=0.0038a 2 P=0.0081a Attack rate (LS mean) 1.5 1.40 74.9% reduction 92.6% b 1 reduction 0.5 0.35 0.10 0.07 0 Placebo/40 mg/day 20 mg/day/ 40 mg/day 40 mg/day/ 40 mg/day OLE overall Placebo 20 mg/day c 40 mg/day d 4

  10. Slide 10: Approximately 80% of participants achieved ≥90% reduction in attack rate

    Approximately 80% of participants achieved ≥90% reduction in attack rate and over half of participants were attack free during the OLE ≥50% reduction ≥70% reduction of participants achieved of participants achieved 93.1% ≥50% reduction in attack rate 93.1% ≥70% reduction in attack rate compared to s

  11. Slide 11: Median proportion of days with HAE attack manifestations

    Median proportion of days with HAE attack manifestations reduced in the RCT and remained low in the OLE RCT OLE with HAE attack manifestations (%) 15% 14.6% Median proportion of days 10% 5% 1.7% 0.0% 0.0% 0% Placebo 20 mg/day a 40 mg/day b 40 mg/day b (N=11) (N=11) (N’=29) (N=10) HAE, hereditary ang

  12. Slide 12: Key takeaways

    Key takeaways The ongoing Phase 2 CHAPTER-1 OLE study provides further evidence on the long-term safety and efficacy of oral deucrictibant for prevention of HAE attacks. Safety Efficacy 1.5 YEARS 0 Median proportion Deucrictibant was Reduced attack rate in the ~80% of participants of days with sympt

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