Pharvaris' Oral HAE Treatment Shows Promise in Phase 3 Trial, Enters Competitive Market

Pharvaris, a Netherlands-based biotechnology company, has announced positive results from a Phase 3 trial of its oral medication for hereditary angioedema (HAE), a rare swelling disorder. The drug, deucrictibant, demonstrated significant efficacy in relieving HAE attack symptoms, potentially positioning it as a strong contender in an increasingly competitive market.

Trial Results and FDA Submission Plans

The Phase 3 trial showed that deucrictibant began relieving symptoms of an HAE attack within a median time of 1.28 hours, significantly faster than the placebo. Moreover, the median time to complete resolution of symptoms was 11.95 hours, a notable improvement compared to existing treatments.

Based on these promising results, Pharvaris plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2026. The company is also conducting a Phase 3 trial for an extended-release formulation of deucrictibant to prevent HAE attacks, with data expected next year.

Market Landscape and Competition

The HAE treatment market has seen significant advancements in recent years, with several new entrants offering both on-demand and preventive options. Notable developments include:

1. Kalvista's Ekterly: Approved by the FDA in 2025, Ekterly became the first oral medication for relieving HAE attacks. It reported strong initial sales of $13.7 million in the third quarter of 2025, exceeding analyst expectations.

2. Injectable treatments: Two new injectable drugs were recently launched, including one for attack relief and another for prevention.

3. CSL's Andembry and Ionis Pharmaceuticals' Dawnzera: Both preventive shots received FDA approval in 2025.

The introduction of these new treatments, particularly oral options, has expanded the market and increased competition. Leerink Partners analyst Joseph Schwartz noted, "We continue to believe that the HAE market is large enough for multiple players, especially as it continues to expand with the entrance of new options."

Comparative Efficacy and Market Dynamics

While deucrictibant's Phase 3 results appear promising, with a numerically faster onset of symptom relief compared to Ekterly (1.28 hours vs. 1.79 hours), it's important to note that these drugs haven't been tested head-to-head. The competitive landscape may be influenced by factors beyond efficacy alone.

Stifel analyst Paul Matteis, who covers Kalvista, suggested that subtle differences in efficacy might not necessarily drive patients to switch once they have begun taking a particular treatment. He noted that Kalvista has already achieved approximately 10% market penetration within a few months and "will have the opportunity to entrench itself further" before deucrictibant potentially gains approval.

As the HAE treatment market continues to evolve, patients and healthcare providers will have an increasing array of options, potentially improving outcomes for those affected by this rare disorder. The success of oral treatments like Ekterly and potentially deucrictibant may signal a shift towards more convenient administration methods in HAE management.