Pharvaris (NASDAQ: PHVS) announced that results from a study validating patient-reported outcomes for hereditary angioedema treatment have been published in Clinical Reviews in Allergy & Immunology. The non-interventional study assessed patient experiences during acute HAE attacks to support clinical trial endpoint development.

The mixed-methods study included participants with hereditary angioedema in the United States who treated attacks with standard care in real-world clinical practice. Researchers evaluated Patient Global Impression and Angioedema syMptom Rating scAle instruments to capture patient experiences and define meaningful change thresholds for clinical trials.

Study results showed that PGI and AMRA instruments are reliable tools for assessing patient-reported outcomes in HAE attacks. The research found that patients considered skin swelling, abdominal pain, difficulty swallowing, and voice changes as important concepts. Qualitative interviews confirmed that small improvements could be meaningful to patients.

The study demonstrated consistency across patient-reported outcome assessments, with End of Progression being the first-achieved endpoint, followed by symptom relief and resolution. The median time to initial symptom relief aligned more closely with AMRA-3 scores of 20% improvement rather than 30% improvement.

"By validating patient-reported outcome measures in a real-world setting, we are ensuring that the experience and voices of people living with HAE directly inform how we assess new therapies in development," said Peng Lu, Chief Medical Officer of Pharvaris.

The findings informed the endpoint hierarchy in Pharvaris' Phase 3 RAPIDe-3 trial of deucrictibant, an oral bradykinin B2 receptor antagonist being developed for on-demand treatment of HAE attacks. The company is preparing marketing authorization applications for deucrictibant immediate-release capsules and conducting ongoing Phase 3 studies.