tiprankstipranks
Pharvaris’ PHVS416 in HAE attacks meets primary and secondary endpoints
The Fly

Pharvaris’ PHVS416 in HAE attacks meets primary and secondary endpoints

Pharvaris announced positive top-line data from the RAPIDe-1 Phase 2 clinical study, demonstrating statistically significant results of PHVS416 as an oral on-demand treatment for hereditary angioedema – or HAE – attacks. RAPIDe-1 is a Phase 2 dose-ranging study of PHVS416 softgel capsule for the acute treatment of angioedema attacks in patients with Type I or II HAE. Seventy-four patients were enrolled. The primary endpoint of the study is the change of a three-symptom composite visual analogue scale score from pre-treatment to four hours post-treatment. Topline data from 147 attacks collected by 62 patients show that dose levels of PHVS416 significantly reduces attack symptoms. All key secondary endpoints of the study were met, demonstrating that PHVS416 significantly: shortens the time to onset of symptom relief by a greater than or equal to30% reduction ; decreases time to a greater than or equal to 50% reduction in VAS-3 score; reduces time to almost complete or complete symptom relief by VAS-3; reduces mean symptom complex severity score from pre-treatment to four hours post-treatment. All other secondary endpoints were met. Participants on PHVS416 also used substantially less rescue medication compared to placebo. PHVS416 was generally well tolerated with no treatment-related serious adverse events and no adverse events leading to treatment discontinuation.

Published first on TheFly

See Insiders’ Hot Stocks on TipRanks >>

Read More on PHVS:

Trending

Name
Price
Price Change
S&P 500
Dow Jones
Nasdaq 100
Bitcoin

Popular Articles