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Pharvaris Phase 3 Trial for Oral HAE Treatment Meets All Endpoints

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PHVS$31.12 −1.77%

Pharvaris N.V. (NASDAQ:PHVS) announced that its Phase 3 RAPIDe-3 clinical trial of oral deucrictibant immediate release successfully met its primary endpoint and all 11 secondary endpoints. The study evaluated the drug as an on-demand treatment for hereditary angioedema (HAE) attacks. The trial demonstrated rapid control of symptoms with no safety signals, and a single capsule was sufficient to manage the majority of HAE attacks. The findings were published in the medical journal The Lancet.

These positive late-stage results validate the efficacy and safety profile of the oral therapy, potentially offering a more convenient alternative to existing injectable treatments for HAE patients. The successful trial reduces regulatory risks for the company's on-demand HAE program as it moves through the registration process. Currently, a New Drug Application for the treatment is under active review by the U.S. Food and Drug Administration.

Investors and clinicians will be watching the FDA's upcoming decision, with a target action date set for April 23, 2027. Regulatory reviews by the European Medicines Agency and any potential regulatory advisory committee meetings will also be key factors in determining the commercial future and market adoption of the drug.

Key points

  • Pharvaris announced its Phase 3 RAPIDe-3 trial of oral deucrictibant met its primary and all 11 secondary endpoints for treating HAE attacks.
  • The trial showed rapid control of symptoms with no safety concerns, and most attacks were managed with a single capsule.
  • The peer-reviewed clinical data from the late-stage study was published in the medical journal The Lancet.
  • The FDA is currently reviewing a New Drug Application for the drug, with a target decision date of April 23, 2027.

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Questions and answers

What were the results of the Pharvaris Phase 3 trial for deucrictibant?

The RAPIDe-3 trial met its primary endpoint and all 11 secondary endpoints for treating hereditary angioedema attacks, showing rapid symptom control and no safety signals.

When is the FDA decision date for Pharvaris' HAE drug?

The U.S. Food and Drug Administration has set a target action date of April 23, 2027, to complete its review of the drug's New Drug Application.

How is deucrictibant administered for hereditary angioedema attacks?

Deucrictibant is an oral medication, and the Phase 3 clinical trial demonstrated that a single capsule was able to control most attacks.