Turnaround For Pharvaris Since FDA Clinical Hold - Data Shows Its Oral Hereditary Angioedema Treatment Cuts Attacks

Pharvaris NV PHVS released topline data from the CHAPTER-1 Phase 2 study meeting its primary endpoint, with deucrictibant demonstrating statistically significant and clinically meaningful results as an oral preventative treatment for people living with hereditary angioedema (HAE). 

In August 2022, the FDA placed clinical studies of deucrictibant, including CHAPTER-1, on hold. 

In June 2023, Pharvaris announced the removal of the clinical hold of deucrictibant for the on-demand treatment of HAE in the U.S.

The study's primary endpoint measured the time-normalized number of investigator-confirmed HAE attacks during treatment. 

The monthly attack rate was reduced by 84.5% (p=0.0008) compared to placebo in participants who received 40 mg/day of deucrictibant.

• 92.3% reduction in the occurrence of moderate and severe attacks
• 92.6% fewer attacks treated with on-demand medication by participants

In the analysis of the secondary endpoints, deucrictibant demonstrated a clinically meaningful improvement in the severity of attacks and a decrease in the number of attacks treated with on-demand medication. 

Throughout 12 weeks of treatment in CHAPTER-1, both doses of deucrictibant were well-tolerated. 

There were no serious adverse events, no severe treatment-emergent adverse events, and no adverse events leading to treatment discontinuation.

Pharvaris priced an underwritten offering of 11.125 million at $24 per share and pre-funded warrants to purchase 1.375 million shares at $23.99 per pre-funded warrant, with approximately $300 million in gross proceeds. 

Price Action: PHVS shares are up 28.2% at $26.86 on the last check Wednesday.