Pharvaris Pill Provides Rapid Relief In Patients With Rare Swelling Attacks, Data Shows
Pharvaris N.V. (NASDAQ:PHVS) on Wednesday shared topline data from the RAPIDe-3 Phase 3 trial of deucrictibant for the on-demand treatment of hereditary angioedema (HAE) attacks.
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HAE is a rare genetic disorder that causes recurrent, severe swelling in the skin, face, limbs, and internal organs, including the airway and gastrointestinal tract.
The study enrolled a total of 134 participants that evaluated the orally administered deucrictibant immediate-release (IR) capsule for the on-demand treatment of attacks in people 12 years and older with HAE.
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Data
The company said the data from its first pivotal Phase 3 study will serve as the basis for marketing authorization applications, which are planned to be filed starting in the first half of 2026.
Compared to placebo, deucrictibant demonstrated faster median time to onset of treatment response:
- Time to onset of symptom relief by PGI-C3 at least “a little better”: 1.28 hours versus >12 hours.
- Time to End of Progression: 17.47 minutes versus 228.67 minutes.
Shorter median time to substantial symptom relief and earlier complete symptom resolution.
The data also showed fewer attacks treated with a second dose or rescue medication within 12 hours.
- 83.0% of attacks were treated with a single capsule of deucrictibant IR.
- 93.2% of deucrictibant-treated attacks were treated without use of rescue medication.
In RAPIDe-3, deucrictibant was well tolerated with no treatment-related serious adverse events and no participants discontinuing treatment due to treatment-emergent adverse events.
An open-label extension of deucrictibant for the on-demand treatment of HAE attacks, RAPIDe-2 Part B, is ongoing.
Competitive Landscape
In August, the U.S. Food and Drug Administration (FDA) approved Ionis Pharmaceuticals, Inc.'s (NASDAQ:IONS) Dawnzera (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
The study met its primary endpoint, with Dawnzera Q4W significantly reducing the monthly HAE attack rate by 81% compared to placebo over 24 weeks.
Mean attack rate reduction increased to 87% when measured from the second dose, a key secondary endpoint.
In July, the FDA approved KalVista Pharmaceuticals Inc.'s (NASDAQ:KALV) Ekterly (sebetralstat) for acute attacks of HAE in adult and pediatric patients aged 12 years and older.
Ekterly is the first and only oral on-demand treatment for HAE.
PHVS Price Action: Pharvaris shares were up 12.32% at $27.09 at the time of publication on Wednesday, according to Benzinga Pro data.
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