Reporting the financial results for the third quarter ended 30 September 2021, Pharvaris co-founder and CEO Berndt Modig says:

“This quarter we continued to execute on our robust clinical development strategy as we seek to advance novel treatments for HAE patients that offer efficacy without compromising on convenience. We continue enrolling patients in RAPIDe-1, our Phase 2 on-demand study of PHVS416, and have begun recruiting in CHAPTER-1, our Phase 2 prophylactic study of PHVS416 for the prevention of HAE attacks. We expect to report top-line data, including efficacy and safety, for both studies in 2022. This month, in the PHVS719 program for HAE prophylaxis we also expect to initiate dosing in a Phase 1 pharmacokinetic study designed to assess the bioavailability of extended-release formulation.”

Recent Pipeline and Business Highlights and Upcoming Milestones

  • Phase 2 on-demand study (RAPIDe-1) of PHVS416 proceeding toward data readout in 2022. In February 2021, Pharvaris announced that dosing had commenced in its Phase 2 clinical study of PHVS416 for the on-demand treatment of HAE attacks. The company reaffirms guidance for reporting topline efficacy and safety data from this study in 2022. Pharvaris is conducting RAPIDe-1 at 33 sites in Canada, Europe, Israel, the UK, and the US.
  • Phase 2 prophylactic study (HAE CHAPTER-1) of PHVS416 recruiting. In addition to developing PHVS416 for the on-demand treatment of HAE attacks, the company plans to investigate the therapeutic potential of the PHVS416 formulation of PHA121 for the prophylactic prevention of HAE attacks. In April 2021, Pharvaris announced that an IND was in effect in the US. Patient recruitment has begun and the study is expanding to Canada, Europe, Israel, and the UK. Pharvaris anticipates reporting topline safety and efficacy data from this study in 2022.
  • Phase 1 pharmacokinetics study of PHVS719 initiating shortly. PHVS719 is under development as an extended-release formulation of PHA121 intended for use in the prophylactic treatment of HAE. Dosing of a Phase 1 pharmacokinetics study to assess the bioavailability of the extended-release formulation is expected to begin this month.

(Source: Pharvaris)