Pharvaris Presents Data Supporting HAE Drug Development Strategy at the 2022 HAEi Global Leadership Workshop
ZUG, Switzerland, Oct. 07, 2022 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the presentation of preclinical and clinical data of PHA121, and its two formulations – softgel capsule PHVS416 and extended-release tablet PHVS719, for the treatment of HAE at the 2022 HAEi Global Leadership Workshop being held October 6-9, 2022, in Frankfurt, Germany. The poster, titled “Development of two novel oral formulations of a first-in-class bradykinin B2 receptor antagonist for on-demand and prophylactic treatment of hereditary angioedema,” was presented by Marcus Maurer, M.D., Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charité – Universitätsmedizin Berlin, and Co-Director of Allergology and Immunology at the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP.
“Treating HAE requires addressing excess bradykinin in the body as bradykinin is the direct cause of HAE attacks,” said Dr. Maurer. “Although there are approved therapies for people living with HAE around the globe, there is still an unmet need related to treatment efficacy, tolerability, and administration preference. Novel, safe, and effective treatments are in development to address the need of the HAE community.”
The poster included preclinical and clinical data supporting Pharvaris’ development strategy for two oral therapies, one for on-demand treatment and one for prophylactic treatment of HAE attacks. Preclinical in-vitro and ex-vivo studies demonstrate that PHA121, the active ingredient in PHVS416 and PHVS719, is 25-fold more potent than icatibant at inhibiting bradykinin activation of the endogenous human B2 receptor. Tailored formulations of PHA121 achieved exposure levels predicted from a human bradykinin challenge study to be effective in treating acute HAE attacks and reducing the likelihood of HAE attacks with a convenient single-dose oral administration. The poster included data supporting the suitability of the pharmacokinetics of PHVS416 for the on-demand treatment of HAE with therapeutic exposure above EC85 within 30 minutes and of PHVS719 daily for the prophylactic treatment of HAE with extended release and absorption from the GI tract providing the necessary therapeutic exposure for more than 24 hours.
Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, added, “By tailoring the formulations of PHA121, Pharvaris has developed two distinct oral therapeutic candidates to specifically address the unmet need of those living with HAE. The softgel capsule, PHVS416, has shown to have a rapid onset of action, which is preferred for the on-demand treatment of HAE, while the extended-release tablet formulation, PHVS719, has shown sustained therapeutic exposure, which supports its use in prophylaxis. We remain ever grateful to the HAE community, clinical trial participants, and site investigators and staff, without whom we would not be able to continue to advance science as we strive to improve treatment options for people living with HAE.”
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.
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