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Pharvaris N.V. (PHVS) is a pioneering, clinical-stage biopharmaceutical company dedicated to developing novel, oral bradykinin B2 receptor antagonists for the treatment and prevention of hereditary angioedema (HAE) and other related conditions. With a strategic focus on unmet medical needs in rare diseases, Pharvaris aims to provide safer, more effective, and easier-to-administer alternatives to currently available injectable therapies.
Core Business and Expertise
Pharvaris is spearheaded by a team with profound expertise in HAE, including the discovery and approval of the HAE treatment icatibant. The company leverages this foundation to develop small, potent molecules targeting the bradykinin B2 receptor—a clinically validated therapeutic target. By inhibiting bradykinin signaling at this receptor, Pharvaris' lead candidate, deucrictibant, offers potential for both acute and prophylactic treatment of HAE and other bradykinin-mediated diseases.
Current Projects and Achievements
- Pharvaris has made significant progress in its clinical development programs. Notably, the U.S. FDA has lifted the clinical hold on deucrictibant, allowing the continuation of global development, including Phase 2 and Phase 3 trials.
- The company's Phase 2 CHAPTER-1 study demonstrated positive top-line data for deucrictibant in preventing HAE attacks, with significant reductions in attack rates at both 20 mg/day and 40 mg/day doses.
- Deucrictibant is being developed in two formulations: a rapid-onset capsule for acute treatment and an extended-release tablet for long-term prophylaxis.
Future Outlook
Pharvaris is preparing for the global Phase 3 CHAPTER-3 study and continues to engage with regulatory authorities to align on study designs. The company is also expanding its research into other bradykinin-mediated conditions, aiming to broaden its therapeutic portfolio.
Financial Condition and Market Presence
Strong financial performance and strategic investor support underscore Pharvaris’ potential. The company’s financial health allows it to fund ongoing and future clinical trials while building infrastructure for the anticipated launch of deucrictibant. Pharvaris is committed to operating transparently, with regular updates provided to its stakeholders through its website and regulatory filings.
With a clear mission to transform the treatment landscape for rare diseases, Pharvaris stands out for its innovative approach and dedication to improving patient outcomes.
Pharvaris (Nasdaq: PHVS) reported its financial results for Q4 and full year 2022, revealing a loss of €39.2 million for Q4 and a total loss of €76.3 million for the year. Cash and equivalents stood at €162 million as of December 31, 2022. Upcoming milestones include the release of top-line data from the CHAPTER-1 Phase 2 study of PHVS416 for hereditary angioedema (HAE), expected in 2H2023, and the completion of a non-clinical toxicology study by YE2023. The company has also adopted deucrictibant as the nonproprietary name for PHA121.
Pharvaris (Nasdaq: PHVS) announced positive results from its Phase 2 RAPIDe-1 trial of PHVS416 for treating hereditary angioedema (HAE) at the 2023 HAEi Regional Conference APAC. The trial, which included 74 participants and evaluated 147 HAE attacks, demonstrated significant symptom reduction at four hours post-treatment with PHVS416 compared to placebo, achieving a nominal p-value <0.0001. All primary and key secondary endpoints were met, with participants using less rescue medication. PHVS416 was well tolerated, with minimal treatment-related adverse events. These findings support ongoing development as a potential oral on-demand therapy for HAE attacks.