Pharvaris (NASDAQ:PHVS) executives outlined the company’s late-stage plans in hereditary angioedema (HAE) at Oppenheimer’s Healthcare Conference, emphasizing the unmet need for a highly effective oral therapy across both on-demand (acute) and prophylactic (preventive) treatment settings. CEO Berndt Modig and Maggie Beller discussed the company’s lead candidate deucrictibant, recent phase 3 on-demand data, an upcoming phase 3 prophylaxis readout expected in the third quarter, and near-term regulatory and commercial preparation.
HAE focus and strategy for an oral option
Modig described HAE as a rare, lifelong genetic condition characterized by swelling attacks that can be painful and sometimes life-threatening, including attacks in the throat and severe abdominal attacks. He said untreated attacks can take three to five days to resolve and noted the ongoing burden of anxiety and uncertainty for patients.
Deucrictibant is a bradykinin B2 receptor antagonist, sharing a mechanism with icatibant, Modig said. He added that this mechanism potentially supports use across multiple forms of angioedema, including HAE types 1 and 2, patients with normal C1 inhibitor (sometimes referred to as type 3), and other forms of bradykinin-mediated angioedema. Modig said the company’s strategy includes seeking a broader label in bradykinin-mediated angioedema if regulators accept that approach.
Market dynamics: prophylaxis dominates, but on-demand remains essential
Modig said prophylaxis has become the dominant segment, citing that approximately 63% of patients are on long-term prophylaxis and that the segment represents about 80% of market value, while noting the figures were not U.S.-specific and that European utilization varies by country. He also emphasized that even with prophylaxis, breakthrough attacks occur and patients are generally advised to carry on-demand medication.
As a result, he argued that “almost every HAE patient is an on-demand patient,” with many also on prophylaxis—an interrelationship he said informs Pharvaris’ aim to address both settings.
Phase 3 on-demand results and differentiation themes
Discussing pivotal on-demand results (RAPIDe-3), Modig said the trial compared attack resolution following treatment with either deucrictibant or placebo. He said the study met its primary endpoint and all 11 secondary endpoints with statistical significance. Key patient-reported outcomes included:
- Onset of symptom relief (PGIC): 1.28 hours versus 12 hours for placebo, as described by the company.
- End of progression: 17 minutes, which Modig said reflects when patients first feel the attack is no longer worsening.
Modig emphasized that, in his view, complete attack resolution within a reasonable timeframe is critical for real-world functioning. In discussing differentiation versus another oral on-demand option (KalVista’s Ekterly), he noted the lack of head-to-head data and cautioned on cross-trial comparisons, but pointed to factors he believes could matter to patients and payers, including redosing rates and dosage form. He contrasted Pharvaris’ small softgel capsule with Ekterly’s dosing of two 300 mg tablets per dose, with potential additional tablets if a second dose is required.
Regulatory next steps were described in general terms. Modig said the company expects to submit an NDA in the first half of the year, and, under “customary timelines” and a regular review, he suggested a potential launch about a year later, while stressing timing ultimately depends on regulators.
Prophylaxis program: phase 2 comparisons and phase 3 readout ahead
Looking to the upcoming phase 3 prophylaxis readout (CHAPTER-3) expected in the third quarter, the company framed its opportunity around achieving “injectable-like efficacy” in an oral regimen. Beller said phase 3 data for approved injectables have shown about 80%–87% attack reduction, compared with 44% attack reduction cited for ORLADEYO, and said Pharvaris’ phase 2 data read out at approximately 84.5% attack reduction.
Beller said CHAPTER-3 expands on phase 2 by:
- Including adolescents
- Including patients with normal C1 inhibitor
- Expanding the geographic footprint, adding sites in APAC and LATAM
She also said the prophylaxis phase 3 program will switch from a twice-daily immediate-release capsule (used in earlier studies) to a once-daily extended-release tablet, which management believes will provide a more stable pharmacokinetic profile. Modig cited a small investigator-sponsored dataset in acquired angioedema mentioned in the corporate deck—four patients over 18 months on the extended-release formulation with no attacks—while cautioning that trials differ and the phase 3 data will be determinative.
When asked what would constitute a “win” in phase 3, Modig said the aim is to replicate phase 2 performance and maintain meaningful differentiation among oral options, noting that injectable efficacy appears “in the mid-80s.”
Upcoming medical meeting and cash runway
At the upcoming AAAAI meeting, Beller said Pharvaris will present six posters, including its first presentation of phase 3 top-line on-demand data to the medical community and final data from the CHAPTER-1 open-label extension (prophylaxis with twice-daily dosing). She said patients in that extension have been on therapy for over three years and that the open-label extension showed 92.3% attack reduction from randomized study baseline. Additional posters will cover the extended-release formulation, endpoint-related work (including AMRA for on-demand), and a biomarker study.
On financials, Modig said the company has guided cash runway into the first half of 2027, while also noting increased spending this year as Pharvaris ramps commercial preparations and grows its team ahead of potential launch timelines.
About Pharvaris (NASDAQ:PHVS)
Pharvaris is a clinical-stage biopharmaceutical company focused on discovering and developing novel oral therapies for rare bradykinin-driven diseases. The company’s core mission is to address conditions characterized by uncontrolled activation of the plasma kallikrein-kinin system, with a primary emphasis on hereditary angioedema (HAE), a debilitating disorder marked by recurrent swelling episodes.
The company’s lead program, PHA121, is an investigational once-daily oral plasma kallikrein inhibitor designed for prophylactic treatment of HAE and is advancing through clinical trials.
