Pharvaris’ Oral HAE Therapy Shows Promise, Could Disrupt $12.79B Market

Boston, MA – November 10, 2025 – Pharvaris, a clinical-stage biotech company, is poised to potentially disrupt the $12.79 billion Hereditary Angioedema (HAE) therapeutics market with promising late-stage trial data for its oral therapy, deucrictibant. The drug, designed for both prophylactic and on-demand treatment, is demonstrating strong efficacy and a favorable safety profile, offering a potential leap forward for patients who currently rely on injectable therapies.

A New Approach to HAE Treatment

Hereditary Angioedema is a rare, debilitating genetic disorder causing unpredictable swelling attacks that can affect any part of the body. Current treatments largely consist of C1 esterase inhibitors and bradykinin B2 receptor antagonists, many requiring frequent injections. Pharvaris’ approach focuses on delivering an effective oral therapy that could significantly improve patient quality of life.

“The current treatment landscape is burdensome for patients,” said an industry analyst. “Injectable therapies require frequent administration, impacting daily routines. An effective oral option would be a game-changer.”

The company recently presented data from the ongoing open-label extension (OLE) of its Phase 2 CHAPTER-1 study at the ACAAI Annual Scientific Meeting, revealing sustained efficacy and a well-tolerated safety profile over approximately 34 months. Participants experienced an average attack reduction of 92.4% from baseline, along with improvements in disease control and quality of life.

Pivotal Trials Underway

Beyond the promising OLE data, Pharvaris is actively conducting two pivotal Phase 3 trials: CHAPTER-3, evaluating deucrictibant for prophylactic use, and RAPIDe-3, assessing its efficacy for on-demand treatment. Both trials have achieved enrollment milestones, with topline data expected in the coming months.

CHAPTER-3, a double-blind, placebo-controlled study, is investigating the potential of once-daily oral deucrictibant extended-release tablets to prevent HAE attacks. RAPIDe-3, on the other hand, is evaluating deucrictibant immediate-release capsules to rapidly resolve acute swelling episodes. This dual approach addresses both the preventative and acute needs of HAE patients.

“Having a therapy that can both prevent attacks and quickly resolve them is critical for patients,” explained a patient advocate. “It provides peace of mind and allows them to live fuller lives.”

Market Landscape and Competitive Dynamics

The HAE therapeutics market is currently dominated by established players like CSL Behring, Takeda, and BioCryst. However, the market is evolving rapidly, with a growing demand for more convenient and patient-friendly therapies. BioCryst's Orladeyo currently holds a prominent position as an oral prophylactic therapy, but Pharvaris’ potential to offer both prophylactic and on-demand oral treatment positions it as a significant competitor.

“The rise of oral therapies is reshaping the HAE market,” stated an investment analyst. “Patients are increasingly seeking alternatives to injections, creating opportunities for companies like Pharvaris.”

Furthermore, Intellia Therapeutics is developing a CRISPR-based gene-editing therapy for HAE, potentially offering a one-time curative treatment. While still in early stages of development, this represents a long-term disruptive force in the market.

Novel Biomarker Assay Offers Diagnostic Promise

Alongside its therapeutic development, Pharvaris has also introduced a novel kinin biomarker assay, addressing a critical need in HAE diagnosis. Traditional methods often struggle to accurately identify the underlying cause of swelling attacks, particularly in cases with normal C1 inhibitor levels. This new assay offers a more sensitive and specific approach to diagnosis, potentially leading to earlier and more accurate treatment.

“The current diagnostic tools are often inadequate,” commented a physician specializing in HAE. “A reliable biomarker assay would be invaluable in identifying patients and guiding treatment decisions.”

Safety and Tolerability Profile

Based on available clinical trial data, deucrictibant demonstrates a favorable safety and tolerability profile. The CHAPTER-1 OLE study, with data extending up to 34 months, reported no significant treatment-related adverse events. Similarly, the RAPIDe-2 study, evaluating deucrictibant for on-demand treatment, showed that the drug was generally well-tolerated.

“The safety profile is crucial for any therapy,” emphasized a clinical trial participant. “Knowing that a treatment is both effective and well-tolerated provides reassurance.”

Looking Ahead

Pharvaris is poised to become a significant player in the HAE therapeutics market. With pivotal trials nearing completion and promising data emerging, the company is well-positioned to potentially offer a much-needed oral treatment option for HAE patients. The upcoming topline data from the CHAPTER-3 and RAPIDe-3 trials will be pivotal in determining the drug's future and its potential to disrupt the current treatment landscape. Investors are closely watching Pharvaris, anticipating a potential market opportunity in this growing and underserved therapeutic area.