The Pharvaris NV (NASDAQ: PHVS) stock price surged 66.9% after releasing positive topline data from its RAPIDe-1 Phase 2 clinical study, demonstrating statistically significant results for PHVS416 as an oral on-demand treatment for hereditary angioedema – or HAE – attacks.
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The clinical trial of RAPIDe-1 is a Phase 2 dose-ranging study of PHVS416 soft gel capsule for the acute treatment of angioedema attacks in patients with Type I or II HAE. The study enrolled seventy-four patients.
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Pharvaris also revealed that it was in a robust financial position since it had cash and cash equivalents of €198 million as of September 30, 2022. The company also held a Type A meeting with the FDA regarding the previously announced holds on the clinical studies of PHA121 in the U.S.
The study’s primary endpoint was a change in the three-symptom composite visual analogue scale score from pre-treatment to four hours after treatment.Â
In addition, the company collected topline data from 62 patients who had 147 attacks, which showed that doses of PHVS416 significantly reduced the attack symptoms.
Pharvaris also stated that the study met its secondary endpoints after PHVS416 significantly shortened the onset time for relief symptoms by at least 30% or higher. The drug also decreased the time for the reduction in VAS-3 score by at least 50%.
The drug also reduced the time to almost complete symptom relief by VAS-3, which lowered the complex severity of the symptom scores from pre-treatment to four hours post-treatment. Hence, the study met all its secondary endpoints.Â
The study participants taking PHVS416 also use substantially less rescue medication than those on the placebo. The drug was well-tolerated, and there were no treatment-related serious adverse events leading up to the discontinuation of treatment.
Investors cheered the news, as evidenced by the rally in PHVS stock during premarket trading.
*This is not investment advice.
Pharvaris (PHVS) stock price.
Pharvaris (PHVS) stock price rallied 66.93% to trade at $4.19, rising from Wednesday’s closing price of $2.51.
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