Business Updates and Company Highlights
- Meeting minutes from Type A meeting with
U.S. Food and Drug Administration (FDA) received.Pharvaris will conduct a 26-week rodent toxicology study to resolve the clinical holds in theU.S. The protocol for this nonclinical study has been submitted to the FDA for review. - FDA approval of dosing of final
U.S. participants in RAPIDe-1 received. The FDA has agreed to partially lift the hold on on-demand to allow the two remainingU.S. participants in RAPIDe-1 to complete treatment of the last attack per the protocol. Positive top-line data from RAPIDe-1 was announced inDecember 2022 . RAPIDe-2, a long-term extension study of PHVS416 for the on-demand treatment of HAE, is currently on hold in theU.S. and is underway outside theU.S. - Top-line data from CHAPTER-1, a global Phase 2 study of PHVS416 for the prophylactic treatment of HAE attacks, anticipated 2H2023. CHAPTER-1 is currently on hold in the
U.S. All active sites outside of theU.S. continue to recruit participants in the CHAPTER-1 clinical study. After being notified of the clinical holds in theU.S. by the FDA,Pharvaris informed country-specific regulatory authorities inCanada ,Europe ,Israel , and theUK regarding the clinical holds in theU.S. To date, the regulatory status of the CHAPTER-1 study outside theU.S. remains unchanged. Based on the Company’s current assumptions regarding ex-U.S. regulatory status and enrollment,Pharvaris anticipates announcing top-line data from the CHAPTER-1 trial in 2H2023. - Cash runway into 4Q2024.
Pharvaris remains diligent in its operational management and is focusing on its existing clinical HAE pipeline to extend runway into 4Q2024.
Upcoming Data Presentation
American Academy of Allergy , Asthma & Immunology (AAAAI) Annual Meeting.San Antonio, TX ,February 24-27, 2023 . Details for the accepted poster presentation at AAAAI are as follows:- Title: Efficacy And Safety Of Bradykinin B2 Receptor Inhibition With Oral PHVS416 In Treating Hereditary Angioedema Attacks: Results Of RAPIDe-1 Phase 2 Trial
- Presenter: Prof.
Marcus Maurer - Date, Time:
Sunday, February 26, 2023 ,9:45-10:45 a.m. CST
About
Forward-Looking Statements
This 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 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 PHA121 clinical trials in the
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
Contact
Director of Corporate Relations
maryann.cimino@pharvaris.com
+1-617-710-7305
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