Pharvaris Drug Shows Lightning-Fast Relief for Rare Swelling Disorder in Phase 3 Trial

MarketDash Editorial Team
5 days ago
Pharvaris releases promising Phase 3 results for its oral hereditary angioedema treatment, showing relief in just over an hour compared to more than 12 hours for placebo, with most patients needing only a single dose.

Pharvaris N.V. (PHVS) delivered some impressive Phase 3 data on Wednesday that should make life considerably better for people suffering from hereditary angioedema. The results from the RAPIDe-3 trial show that deucrictibant, the company's oral treatment, works remarkably fast when HAE attacks strike.

For context, hereditary angioedema is a rare genetic disorder that causes recurrent, severe swelling in the skin, face, limbs, and internal organs—including the airway and gastrointestinal tract. When an attack hits, you want relief fast.

The study enrolled 134 participants aged 12 and older with HAE, testing deucrictibant's immediate-release capsule as an on-demand treatment when attacks occur. The company plans to use this data as the foundation for marketing authorization applications, which they're targeting to file starting in the first half of 2026.

The Speed Advantage

Here's where things get interesting. Compared to placebo, deucrictibant showed dramatically faster results across multiple measures. The median time to onset of symptom relief hit 1.28 hours, compared to more than 12 hours for placebo. That's not a marginal improvement—that's a game changer.

The time to end of progression was even more striking: 17.47 minutes versus 228.67 minutes for placebo. Beyond just faster initial relief, patients experienced shorter times to substantial symptom relief and earlier complete resolution of symptoms.

Perhaps more importantly for patients, most attacks were handled with a single dose. A full 83% of attacks were successfully treated with just one capsule of deucrictibant IR, and 93.2% of treated attacks didn't require rescue medication within 12 hours. That suggests the drug doesn't just work fast—it works well enough that patients aren't scrambling for backup options.

Safety Profile Looks Clean

On the safety front, deucrictibant was well tolerated in RAPIDe-3. The trial recorded no treatment-related serious adverse events, and not a single participant discontinued treatment due to treatment-emergent adverse events. An open-label extension study, RAPIDe-2 Part B, is currently ongoing to gather additional long-term data.

Crowded Field Getting More Crowded

Pharvaris isn't alone in this space. The competitive landscape for HAE treatments has been heating up considerably.

Back in August, the FDA approved Ionis Pharmaceuticals, Inc. (IONS) Dawnzera (donidalorsen) for prophylaxis to prevent HAE attacks in patients 12 years and older. That study met its primary endpoint with Dawnzera significantly reducing the monthly HAE attack rate by 81% compared to placebo over 24 weeks. The mean attack rate reduction jumped to 87% when measured from the second dose, hitting a key secondary endpoint.

Then in July, the FDA approved KalVista Pharmaceuticals Inc. (KALV) Ekterly (sebetralstat) for acute attacks of HAE in patients aged 12 years and older. Ekterly became the first and only oral on-demand treatment for HAE—at least until Pharvaris potentially joins that club.

The distinction matters: Dawnzera is preventive (prophylaxis), while Ekterly and deucrictibant are on-demand treatments for when attacks actually happen. Different approaches for different patient needs.

Pharvaris shares jumped 12.32% to $27.09 following the announcement, according to market data.

Pharvaris Drug Shows Lightning-Fast Relief for Rare Swelling Disorder in Phase 3 Trial

MarketDash Editorial Team
5 days ago
Pharvaris releases promising Phase 3 results for its oral hereditary angioedema treatment, showing relief in just over an hour compared to more than 12 hours for placebo, with most patients needing only a single dose.

Pharvaris N.V. (PHVS) delivered some impressive Phase 3 data on Wednesday that should make life considerably better for people suffering from hereditary angioedema. The results from the RAPIDe-3 trial show that deucrictibant, the company's oral treatment, works remarkably fast when HAE attacks strike.

For context, hereditary angioedema is a rare genetic disorder that causes recurrent, severe swelling in the skin, face, limbs, and internal organs—including the airway and gastrointestinal tract. When an attack hits, you want relief fast.

The study enrolled 134 participants aged 12 and older with HAE, testing deucrictibant's immediate-release capsule as an on-demand treatment when attacks occur. The company plans to use this data as the foundation for marketing authorization applications, which they're targeting to file starting in the first half of 2026.

The Speed Advantage

Here's where things get interesting. Compared to placebo, deucrictibant showed dramatically faster results across multiple measures. The median time to onset of symptom relief hit 1.28 hours, compared to more than 12 hours for placebo. That's not a marginal improvement—that's a game changer.

The time to end of progression was even more striking: 17.47 minutes versus 228.67 minutes for placebo. Beyond just faster initial relief, patients experienced shorter times to substantial symptom relief and earlier complete resolution of symptoms.

Perhaps more importantly for patients, most attacks were handled with a single dose. A full 83% of attacks were successfully treated with just one capsule of deucrictibant IR, and 93.2% of treated attacks didn't require rescue medication within 12 hours. That suggests the drug doesn't just work fast—it works well enough that patients aren't scrambling for backup options.

Safety Profile Looks Clean

On the safety front, deucrictibant was well tolerated in RAPIDe-3. The trial recorded no treatment-related serious adverse events, and not a single participant discontinued treatment due to treatment-emergent adverse events. An open-label extension study, RAPIDe-2 Part B, is currently ongoing to gather additional long-term data.

Crowded Field Getting More Crowded

Pharvaris isn't alone in this space. The competitive landscape for HAE treatments has been heating up considerably.

Back in August, the FDA approved Ionis Pharmaceuticals, Inc. (IONS) Dawnzera (donidalorsen) for prophylaxis to prevent HAE attacks in patients 12 years and older. That study met its primary endpoint with Dawnzera significantly reducing the monthly HAE attack rate by 81% compared to placebo over 24 weeks. The mean attack rate reduction jumped to 87% when measured from the second dose, hitting a key secondary endpoint.

Then in July, the FDA approved KalVista Pharmaceuticals Inc. (KALV) Ekterly (sebetralstat) for acute attacks of HAE in patients aged 12 years and older. Ekterly became the first and only oral on-demand treatment for HAE—at least until Pharvaris potentially joins that club.

The distinction matters: Dawnzera is preventive (prophylaxis), while Ekterly and deucrictibant are on-demand treatments for when attacks actually happen. Different approaches for different patient needs.

Pharvaris shares jumped 12.32% to $27.09 following the announcement, according to market data.

    Pharvaris Drug Shows Lightning-Fast Relief for Rare Swelling Disorder in Phase 3 Trial - MarketDash News