Swiss biopharma company Pharvaris will file for US approval of deucrictibant XR in the rare swelling disorder hereditary angioedema (HAE), after the medicine met its goals in a Phase III study.
This success stems from the late-stage CHAPTER-3 trial (NCT06669754), in which Pharvaris pitted a once-daily, oral dose of deucrictibant XR against placebo as a preventative therapy to prevent HAE attacks in adolescents and adults with the condition.
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During the study, those treated with deucrictibant XR experienced a statistically significant 83% drop in the mean monthly HAE attack rate over placebo across all subgroups, while further analysis on patients with Type 1 or 2 HAE showed that the drug triggered an 87% reduction in monthly attacks.
The drug’s activity also had a rapid onset, which was sustained throughout the 24-week study period, while increasing the proportion of patients remaining attack-free versus placebo.
On top of its ability to rapidly diminish HAE attack rates, Pharvaris stated that deucrictibant XR met all its secondary efficacy endpoints, though the company is yet to share further details on this.
Patients also tolerated the drug well in CHAPTER-3, with a majority of treatment-linked side effects sitting in the mild-to-moderate range, and researchers reporting no serious events. There was one discontinuation in both the treatment and placebo group due to an adverse event.
Pharvaris eyes the growing HAE market
With this positive data in hand, Pharvaris plans to file for deucrictibant XR’s approval with the US Food and Drug Administration (FDA). A new drug application (NDA) is slated for the first half of 2027.
If given the regulatory blessing, the oral bradykinin B2 receptor antagonist would join a recent uptick in therapies approved in HAE. In 2025 alone, the FDA approved three innovator drugs for the indication.
HAE treatment is divided into long-term preventative options and on-demand drugs for acute attacks. The former is currently dominated by Takeda’s blockbuster therapy, Takhzyro (lanadelumab), an injectable, twice-monthly option.
However, deucrictibant XR would also face stiff competition from BioCryst’s fellow oral preventative HAE therapy, Orladeyo (berotralstat), which was one of the three drugs to secure the FDA greenlight in 2025 – making it the first pill to reach the HAE market.
Recently, Argo Biopharma touted the differentiated potential of its preventative therapy, BW-20805 after the drug secured a Phase II win at a once-24-weekly dosing schedule.
