Pharvaris provided business updates and outlined its strategic priorities for 2024.

Berndt Modig, Chief Executive Officer of Pharvaris, said: “Pharvaris enters the new year having demonstrated deucrictibant’s potential to be the preferred option for both the prevention and treatment of HAE attacks,” said. “We are operating from a strong financial position and anticipate 2024 will be an important execution year for Pharvaris as we transition into a late-stage clinical company with the initiation of RAPIDe-3 expected within the first half. We have submitted the results of the nonclinical study to the FDA for review with respect to the clinical hold on the long-term prophylaxis program in the U.S. We are also preparing to initiate the global pivotal study, CHAPTER-3, for the prophylaxis against HAE attacks. In parallel, we will be building on our foundation for Pharvaris’ long-term strategy as we invest in our commercial and product infrastructure to support our commitment to provide deucrictibant to people living with HAE.”

Jochen Knolle, PhD, co-founder of Pharvaris, transitions to strategic advisor to the CEO and Executive Committee. He commented: “It has been a privilege working with the HAE community throughout my career. The approval of icatibant as an acute treatment for HAE attacks shifted the paradigm of treatment for people living with HAE, and I anticipate that deucrictibant will have an equally important impact on the HAE community. I look forward to continuing to contribute to the strategic transformation of Pharvaris in my new capacity.”

Business Updates and Company Highlights Pipeline

  • Anticipated initiation of RAPIDe-3 within first half of 2024. RAPIDe-3 is a randomized, double-blind, placebo-controlled, cross-over Phase 3 study designed to evaluate the efficacy and safety of oral deucrictibant immediate-release capsules (PHVS416) for the on-demand treatment of HAE attacks. During the treatment phase, participants will self-administer double-blinded study drug (20 mg deucrictibant immediate-release capsule or placebo, in a crossover fashion) to treat a total of two qualifying attacks. The primary endpoint is time to onset of symptom relief, defined as a Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Secondary endpoints include assessments of time to end of progression of attack symptoms, substantial symptom relief, and symptom resolution, as defined by PGI-C, Patient Global Impression of Severity (PGI-S) and Angioedema syMptom Rating scAle (AMRA), as well as use of rescue medication. Data from a real-world study in HAE with standard-of-care treatments suggest the median time to symptom relief is similar when measured by AMRA-3 ≥20% reduction from pre-treatment and with PGI-C “a little better” on two consecutive timepoints. Safety outcome measures include incidence of treatment-emergent adverse events. After RAPIDe-3 completion, participants may continue treatment with deucrictibant in an open-label extension study. In the RAPIDe-1 Phase 2 study, deucrictibant significantly reduced the time to onset of symptom relief and to resolution of HAE attacks, reduced use of rescue medication, and was well-tolerated.
  • Submission of non-clinical rodent toxicology data to the U.S. Food & Drug Administration (FDA) completed. Pharvaris has submitted the results from the 26-week rodent toxicology study to the FDA. The study was intended to provide additional data to address the clinical hold on the IND of deucrictibant for long-term prophylaxis, and Pharvaris believes the study met its objective. Neither the nature nor timing of the response from FDA is certain.
  • Phase 2 CHAPTER-1 clinical study met its primary endpoint. The primary endpoint of the CHAPTER-1 study measured the time-normalized number of investigator-confirmed HAE attacks during the treatment period. The monthly attack rate was reduced by 84.5% (p=0.0008) compared to placebo in participants who received 40 mg/day of deucrictibant. In the analysis of the secondary endpoints, deucrictibant demonstrated clinically meaningful reductions in the occurrence of moderate and severe attacks and in the number of attacks treated with on-demand medication. Participants on deucrictibant treatment experienced a meaningful improvement in their quality of life as measured by patient global assessment of change (PGA-Change) and angioedema quality of life (AE-QoL) questionnaires. Throughout 12 weeks of treatment in CHAPTER-1, both the 20 mg/day and the 40 mg/day doses of deucrictibant were well-tolerated. The open-label portion of the CHAPTER-1 study is ongoing. Pharvaris is preparing to initiate CHAPTER-3, a global, pivotal study to evaluate deucrictibant for the prophylactic treatment of HAE attacks.

(Source: Pharvaris)