JuSun
Shares of Pharvaris N.V. (NASDAQ:PHVS) climbed ~58% pre-market Thursday after the Dutch biopharma said that its Phase 2 trial for hereditary angioedema (HAE) candidate PHVS416 met the main goals as an oral on-demand treatment for HAE attacks.
The RAPIDe-1 trial was designed to assess PHVS416, an investigational soft gel capsule, as an acute treatment for angioedema attacks with the participation of 74 patients with Type I or II HAE.
The trial subjects received one of three single-dose levels of PHVS416 and a placebo in two phases.
Part I involved the administration of a single dose of PHVS416 at the study center during a non-attack state. During Part II, the patients self-administered the blinded study drug at home in response to HAE attacks.
Per the topline data, RAPIDe-1 met the primary endpoint, considerably reducing HAE attack symptoms, according to the change of visual analog scale (VAS-3) score, which considers skin pain, skin swelling, abdominal pain, from pre-treatment to four hours after treatment.
RAPIDe-1 also reached all key secondary endpoints, including the reduction of time to symptom onset, which indicated a ≥30% drop in the VAS-3 score from the pre-treatment score.
PHVS416 led to no treatment-related serious adverse events, and no patient discontinued the therapy due to adverse events.
Pharvaris (PHVS) continues to enroll patients outside the U.S. for PHVS416 studies in HAE after the FDA imposed a hold on PHA121 trials, including RAPIDe-1.
In conjunction with trial data, the company announced Q3 financials for 2022, indicating €198M cash and equivalents as of Sep. 30.
Image and article originally from seekingalpha.com. Read the original article here.