Pharvaris announces Phase 3 clinical study design for recently initiated RAPIDe-3 study, and presents quality-of-life improvement and caregiver behavior data at two recent HAE congresses
Pharvaris presented at two recent congresses: the 3rd National Congress of the Italian Network for Hereditary and Acquired Angioedema (ITACA) and the 2024 HAE International (HAEi) Regional Conference Americas.
Berndt Modig, Chief Executive Officer of Pharvaris, said: “We are committed to the continued advancement of our clinical development program of deucrictibant to fulfil unmet needs of current HAE treatment. In collaboration with regulatory authorities, we have designed a robust global study to assess the efficacy and safety of deucrictibant, a molecule which we believe has the potential to be best-in-class for both the prevention and treatment of HAE attacks.”
The design of the Phase 3 RAPIDe-3 study was showcased for the first time in two posters on Friday. One titled “Design of RAPIDe-3 Phase 3 Trial: Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks” was presented by Mauro Cancian, MD, PhD, at the ITACA meeting and the second, titled “Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema Attacks: RAPIDe-3 Phase 3 Trial Design” was presented by Anete Grumach, MD, PhD, at the HAEi Americas Congress. RAPIDe-3 is a randomized, double-blind, placebo-controlled, crossover study, which is designed to enroll approximately 120 adolescent and adult participants globally. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of Progression (EoP) in attack symptoms within 12 hours as measured by PGI-C, and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S).
In a poster titled “Prophylactic Treatment with Oral Deucrictibant Improves Health-Related Quality of Life of Patients with Hereditary Angioedema” presented by Andrea Zanichelli, MD, PhD, on Friday at the ITACA meeting, two health-related quality of life (HRQoL) outcomes were measured in participants from CHAPTER-1, a double-blinded, placebo-controlled Phase 2 study evaluating the efficacy and safety of deucrictibant for the prevention of HAE attacks. The data illustrates that HRQoL is negatively impacted, including functional and psychological impairment, in people with HAE. Analyses of CHAPTER-1 study data provide evidence that prophylactic treatment with oral deucrictibant for 12 weeks improved HRQoL for people living with HAE, in addition to significant reduction of attacks.
In a poster titled “Need for Caregiver Support for People Living with Hereditary Angioedema in European Countries,” also presented by Andrea Zanichelli, MD, PhD, on Friday at the ITACA meeting, the Adelphi HAE Disease Specific Programme™ (DSP™) examined caregiver support requirements among people living with HAE in some European countries, as well as the impact of their condition on their HRQoL and ability to work.
(Source: Pharvaris)
