PHVS Pharvaris NV

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 two ePosters at the American College of Allergy, Asthma & Immunology (ACAAI) 2023 Annual Scientific Meeting, being held from November 9-13, 2023 in Anaheim, CA.

Prof. Marc A. Riedl, M.D., M.S., will present a poster titled “Deucrictibant immediate-release capsule reduces time to end of progression of hereditary angioedema attacks’ manifestations” on Friday, November 10, from 5:15-5:30 p.m. PST (8:15-8:30 p.m. EST). In the phase 2 RAPIDe-1 trial, PHVS416 (immediate-release deucrictibant capsules) reduced time to the onset of symptom relief and to the resolution of HAE attacks, and substantially reduced use of rescue medication. End of progression (EoP) of angioedema manifestations, which represents the first event documenting treatment response and the first evidence of attacks evolving towards relief and resolution, was assessed in a post-hoc analysis. All dose groups of PHVS416 achieved EoP at a median time of 25 or 26 minutes vs 20 hours for attacks treated with placebo.

Dr. Joan Mendivil, M.D., will present a poster titled “Understanding the reasons not to treat all HAE attacks and satisfaction for on-demand treatment: physician- and patient-reported data” on Saturday, November 11, from 12:20-12:35 p.m. PST (3:20-3:35 p.m. EST). Data detailed in the poster were drawn from the Adelphi HAE Wave II Disease Specific Program (DSP)™, a real-world, cross-sectional survey of people living with HAE and their treating physicians. People living with HAE reported a lower satisfaction with their current on-demand treatments than their treating physicians in terms of route of administration, discreteness to administer in public, time to resolve attacks, and ease of portability.

“The real-world HAE data and post-hoc analysis of RAPIDe-1 data that will be presented at ACAAI support the compelling story for the ongoing development of PHVS416 for the on-demand treatment of HAE,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “People living with HAE most frequently reported not treating attacks due to existing therapies taking too long to resolve the attack and injection-site reactions. An oral therapy with a faster onset of action may encourage more consistent and timely treatment of HAE attacks and improved treatment satisfaction. Results of the post-hoc RAPIDe-1 analysis provide additional evidence on the rapid onset of effects of PHVS416 for on-demand treatment of HAE attacks.”

About PHVS416 (immediate-release deucrictibant capsules)PHVS416 (immediate-release deucrictibant capsules) is an investigational drug intended to treat attacks of hereditary angioedema (HAE) containing deucrictibant, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris aims to develop this formulation to provide rapid and reliable symptom relief, through rapid exposure of attack-mitigating therapy in an easy-to-administer, small oral dosage form.

About PharvarisBuilding on its deep-seated roots in HAE, Pharvaris is a clinical-stage company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE efficacious, safe, and easy-to-administer alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA with respect to the clinical hold on prophylactic deucrictibant in the U.S.; the expected timing, progress, or success of our clinical development programs, especially for PHVS416 (immediate-release deucrictibant capsules) and PHVS719 (extended-release deucrictibant tablets), which are in mid-stage global clinical trials; risks arising from epidemic diseases, such as the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the expected timing and results of the rodent toxicology study and our ability to resolve any issues to the satisfaction of the FDA or any regulatory agency in a timely manner; the timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws, our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine and the Hamas attack against Israel and the ensuing war; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. 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.

Contact
Maggie Beller
Executive Director, Head of External and Internal Communications
maggie.beller@pharvaris.com