Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced two presentations highlighting data from RAPIDe-1, a Phase 2 study of PHVS416 (deucrictibant immediate-release capsules) for the on-demand treatment of HAE attacks, included in the “Flash Talks on Angioedema” session at the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023, taking place in Hamburg, Germany, from June 9-11, 2023.

Presentation details:

  • Title: Treatment with Oral Administered Bradykinin B2 Receptor Inhibitor PHVS416 Improves Hereditary Angioedema Attack SymptomsAbstract Number: 001557Date/Time: Sunday, June 11, 14:10 CEST (8:10 a.m. EDT)Presenter: Emel Aygören-Pürsün, M.D., University Hospital Frankfurt
  • Title: Efficacy and Safety of Oral Administered Bradykinin B2 Receptor Inhibitor PHVS416 in Treatment of Hereditary Angioedema Attacks: Topline Results of RAPIDe-1 Phase 2 TrialAbstract Number: 001510Date/Time: Sunday, June 11, 14:30 CEST (8:30 a.m. EDT)Presenter: Marcus Maurer, M.D., Charité Universitätsmedizin Berlin

“When asked to identify the most important factor in selecting an on-demand therapy, both people living with HAE and their treating physicians indicated that rapidity to onset of symptom relief and complete symptom relief were essential,” said Wim Souverijns, Ph.D., Chief Community Engagement and Commercial Officer of Pharvaris. “Additionally, our research points to multiple reasons why not all HAE attacks are treated in a timely manner or treated at all, as is recommended by international clinical guidelines, including fear of injection pain, anxiety regarding the ability of a therapy to completely treat an attack with a single dose, and lack of confidence in the speed of symptom relief. An effective oral therapy that provides rapid and complete symptom relief could address some of these barriers.”

“The results from the Phase 2 RAPIDe-1 clinical study show that treatment of an HAE attack with PHVS416 (deucrictibant immediate-release capsules) resulted in rapid and clinically meaningful improvement in symptoms as compared to placebo,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “The study met the primary and all key secondary endpoints, providing evidence for the efficacy and tolerability of PHVS416 in treating HAE attacks and supports its further development as a potential on-demand therapy for HAE.”

The posters are available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations.

About RAPIDe-1RAPIDe-1 is a Phase 2, double-blind, placebo-controlled, randomized, cross-over, dose-ranging trial of PHVS416 (immediate-release deucrictibant capsules) for the treatment of HAE type 1 and type 2 (HAE-1/2) attacks. The trial enrolled participants in Canada, Europe, Israel, the United Kingdom, and the United States. Eligible participants were between the ages of 18 and 75 years, diagnosed with HAE type I or II and experienced three or more attacks in the last four months or two or more attacks in the last two months prior to screening. Seventy-four participants were enrolled and 62 of them experienced 147 qualifying HAE attacks that were treated with double-blinded study drug (either placebo or PHVS416 10, 20, or 30 mg doses).

About PHVS416 (immediate-release deucrictibant capsules)PHVS416 (immediate-release deucrictibant capsules) is an investigational medicine intended to treat acute 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 a convenient, small oral dosage form. PHVS416 is currently in Phase 2 clinical development outside the U.S. for the on-demand and proof-of-concept prophylactic treatment of HAE.

About PharvarisBuilding on its deep-seated roots in hereditary angioedema (HAE), Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks. By directly targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE safe, effective, and convenient 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 holds on deucrictibant clinical trials in the U.S.; the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the clinical holds; 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; 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 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 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
Head of Public Relations and Communications
maggie.beller@pharvaris.com
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