Pharvaris (Nasdaq: PHVS) announced the publication of results from a qualitative study assessing the experiences of people with acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) in Frontiers in Immunology, according to a press release.

The study, which the company describes as the first in-depth qualitative assessment in AAE-C1INH, evaluated disease burden and validated patient-reported outcome (PRO) measures for use in clinical trials. Participants reported frequent, painful swelling attacks, prolonged periods of misdiagnosis, and broad impacts across physical, emotional, social, and work-related domains. All participants in the study relied on off-label therapies, as no treatments are currently approved for the prevention or treatment of AAE-C1INH attacks.

The study assessed the relevance of established PRO instruments, including the Patient Global Impression of Change (PGI-C), Patient Global Impression of Severity (PGI-S), and Patient Global Assessment (PGA). Results indicated these tools are applicable for measuring treatment benefit in AAE-C1INH. The study found that a PGI-C rating of "better" was most consistently considered meaningful by participants at time points up to four hours post treatment.

Pharvaris stated the findings directly informed the design and endpoint selection of its ongoing Phase 3 CREAATE study (NCT07266805), which is investigating deucrictibant for both prophylaxis and on-demand treatment of AAE-C1INH attacks.

Danny M. Cohn, M.D., Ph.D., of Amsterdam UMC and principal investigator in CREAATE, said the study is "an important step forward, capturing the patient experience in a rigorous way and helping to ensure that clinical studies evaluate outcomes that are truly meaningful to patients."

Peng Lu, M.D., Ph.D., President of Pharvaris, noted the findings are "aligned with guidance from the U.S. Food and Drug Administration (FDA)" and said they "strengthen the scientific foundation for the evaluation of treatment benefit in this underserved population."