Pharvaris Says FDA Lifts Clinical Hold On Deucrictibant For On-Demand Treatment Of HAE

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Stocktwits
Pharvaris Says FDA Lifts Clinical Hold On Deucrictibant For On-Demand Treatment Of HAE

(RTTNews) - Pharvaris N.V. (PHVS) announced Monday the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the on-demand treatment of hereditary angioedema or HAE, following review of data from a preplanned interim analysis of the ongoing 26-week nonclinical study.

Pharvaris expects to submit data from the 26-week nonclinical study by the end of 2023 to address the remaining hold on the IND application for deucrictibant for prophylactic treatment of HAE.

"The lift of the clinical hold on on-demand clinical trials enables the company to continue development of PHVS416 (deucrictibant immediate-release capsules) in the U.S., including resuming RAPIDe-2, its extension study for acute treatment of attacks

The company said it plans to request an end of Phase 2 meeting with the FDA and is preparing for RAPIDe-3, its global Phase 3 study of PHVS416 for the on-demand treatment of HAE, to include U.S. sites.

The 26-week nonclinical study to address the remaining hold on prophylactic deucrictibant in the U.S. is still progressing and the company plans to submit the data from that study to the FDA by the end of the year.

Based on current enrollment, the company confirms that top-line data from CHAPTER-1, its Phase 2 proof-of-concept study of PHVS416 for the prophylactic treatment of HAE, remains on track to be announced by the end of the year.

Značky : PHVS
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