Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on the discovery and development of novel oral bradykinin-B2-receptor antagonists for the treatment of hereditary angioedema (HAE) and other bradykinin-B2-receptor-mediated indications, announced the acceptance by the U.S. Food and Drug Administration (FDA) of Pharvaris’ Investigational New Drug (IND) application for the prophylactic study of PHVS416, an oral B2-receptor antagonist for the treatment of hereditary angioedema (HAE).
“The FDA acceptance of the IND for the prophylactic application of PHVS416, the softgel capsule formulation of PHA121, represents another important milestone for this program,” said Berndt Modig, co-founder and chief executive officer of Pharvaris. “PHVS416 is currently being evaluated for the on-demand treatment of HAE attacks in an ongoing Phase 2 clinical study. We look forward to initiating the prophylactic study of PHVS416 as the first step in our plans to bring forward a new option for oral prophylaxis of HAE. Patients are seeking oral alternatives to existing therapies, and we are eager to continue our evaluation of products based on PHA121 for both on-demand and prophylactic settings.”
Pharvaris is a clinical-stage company focused on bringing oral bradykinin-B2-receptor antagonists to patients. By targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team is advancing new alternatives to injected therapies for all sub-types of HAE and other bradykinin-mediated diseases. The company brings together executives with a breadth of expertise across pharmaceutical development and rare disorders, including HAE. For more information, visit https://pharvaris.com/.
PHVS416 is a softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide rapid exposure of attack-mitigating medicine in a convenient, small oral dosage form. PHVS416 is currently in Phase 2 clinical development for the on-demand treatment of HAE.
PHA121 (PHA-022121) is a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor that has completed Phase 1 clinical development for the treatment of HAE. PHA121 utilizes the same mechanism as icatibant, the leading therapy for on-demand treatment of HAE. Pharvaris is developing this novel small molecule for on-demand and prophylactic treatment of HAE and other bradykinin-mediated diseases through formulations optimized for each setting. Data from single- and multiple-ascending-dose Phase 1 studies in healthy volunteers demonstrate rapid exposure and predictable linear pharmacokinetics at doses up to 50 mg. In a bradykinin-challenge study in healthy volunteers, PHA121 showed significant inhibition of bradykinin-induced hemodynamic changes with an average composite EC50 of 2.4 ng/mL and EC85 of 13.8 ng/mL, approximately four-fold more potent than historical data for icatibant. Quantitative modeling indicates that single oral doses of PHA121 will maintain pharmacologically active drug levels for a substantially longer time than 30 mg of subcutaneous icatibant. PHA121 has been observed to be well-tolerated at all doses studied to date.