- RAPIDe-3, a global Phase 3 clinical study of deucrictibant for the on-demand treatment of HAE, to initiate within 1H24
- Results of nonclinical rodent toxicology study submitted to the FDA
Jochen Knolle , Ph.D., to transition to strategic advisor to the CEO andExecutive Committee - Company presentation at the
J.P. Morgan Healthcare Conference
“Pharvaris enters the new year having demonstrated deucrictibant’s potential to be the preferred option for both the prevention and treatment of HAE attacks,” said
Business Updates and Company Highlights
Pipeline
- Anticipated initiation of RAPIDe-3 within 1H2024. RAPIDe-3 is a randomized, double-blind, placebo-controlled, cross-over Phase 3 study designed to evaluate the efficacy and safety of oral deucrictibant immediate-release capsules (PHVS416) for the on-demand treatment of HAE attacks. During the treatment phase, participants will self-administer double-blinded study drug (20 mg deucrictibant immediate-release capsule or placebo, in a crossover fashion) to treat a total of two qualifying attacks. The primary endpoint is time to onset of symptom relief, defined as a Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Secondary endpoints include assessments of time to end of progression of attack symptoms, substantial symptom relief, and symptom resolution, as defined by PGI-C, Patient Global Impression of Severity (PGI-S) and Angioedema syMptom Rating scAle (AMRA), as well as use of rescue medication. Data from a real-world study in HAE with standard-of-care treatments suggest the median time to symptom relief is similar when measured by AMRA-3 ≥20% reduction from pre-treatment and with PGI-C “a little better” on two consecutive timepoints. Safety outcome measures include incidence of treatment-emergent adverse events. After RAPIDe-3 completion, participants may continue treatment with deucrictibant in an open-label extension study. In the RAPIDe-1 Phase 2 study, deucrictibant significantly reduced the time to onset of symptom relief and to resolution of HAE attacks, reduced use of rescue medication, and was well-tolerated.
- Submission of nonclinical rodent toxicology data to the
U.S. Food & Drug Administration (FDA) completed.Pharvaris has submitted the results from the 26-week rodent toxicology study to the FDA. The study was intended to provide additional data to address the clinical hold on the IND of deucrictibant for long-term prophylaxis, andPharvaris believes the study met its objective. Neither the nature nor timing of the response from FDA is certain. - Phase 2 CHAPTER-1 clinical study met its primary endpoint. The primary endpoint of the CHAPTER-1 study measured the time-normalized number of investigator-confirmed HAE attacks during the treatment period. The monthly attack rate was reduced by 84.5% (p=0.0008) compared to placebo in participants who received 40 mg/day of deucrictibant. In the analysis of the secondary endpoints, deucrictibant demonstrated clinically meaningful reductions in the occurrence of moderate and severe attacks and in the number of attacks treated with on-demand medication. Participants on deucrictibant treatment experienced a meaningful improvement in their quality of life as measured by patient global assessment of change (PGA-Change) and angioedema quality of life (AE-QoL) questionnaires. Throughout 12 weeks of treatment in CHAPTER-1, both the 20 mg/day and the 40 mg/day doses of deucrictibant were well-tolerated. The open-label portion of the CHAPTER-1 study is ongoing.
Pharvaris is preparing to initiate CHAPTER-3, a global, pivotal study to evaluate deucrictibant for the prophylactic treatment of HAE attacks.
Corporate
- Closing of
$300 million underwritten offering extends cash runway. The offering of$300 million included participation from General Atlantic, as well as other new and existing institutional investors. The proceeds of the financing will be used to support Pharvaris’ ongoing research and development activities, product discovery expenses, as well as general corporate purposes and working capital.Pharvaris remains diligent in its operational management and now has a cash runway for at least two years. Jochen Knolle , Ph.D., co-founder ofPharvaris , transitions to strategic advisor to the CEO andExecutive Committee .Dr. Knolle , who served as Pharvaris’ Chief Scientific Officer and Chief Operating Officer since the company’s inception, is named as an author or inventor on numerous publications and patents, including for the approved therapeutics quinapril, a marketed ACE inhibitor, and icatibant. Under his leadership,Pharvaris succeeded in identifying deucrictibant, a long-sought-after oral B2 receptor antagonist with sub-nanomolar in vitro potency that utilizes the same mechanism of action as icatibant with a distinctly different chemical structure. Deucrictibant is being developed as two different oral formulations, optimized either for rapid exposure and onset of activity for the acute treatment of HAE attacks or through sustained exposure for preventive treatment of HAE.Dr. Knolle stated, “It has been a privilege working with the HAE community throughout my career. The approval of icatibant as an acute treatment for HAE attacks shifted the paradigm of treatment for people living with HAE, and I anticipate that deucrictibant will have an equally important impact on the HAE community. I look forward to continuing to contribute to the strategic transformation ofPharvaris in my new capacity.”
Upcoming Presentations
- 42nd Annual
J.P. Morgan Healthcare Conference .San Francisco, CA ,January 8-11, 2024 .- Format: Company Presentation
Presenter:Berndt Modig
Date, time:Thursday, January 11, 2024 ,9:00-9:40 a.m. PST (12:00-12:40 p.m. EST )
- Format: Company Presentation
- 20th
BioCapital Europe Conference .Amsterdam, Netherlands ,February 8, 2024 .- Format: Live In-Person Presentation
Presenter:Berndt Modig
Date, time:Thursday, February 8 ,4:00-4:20 p.m. CET (10:00-10:20 a.m. EST )
- Format: Live In-Person Presentation
- Oppenheimer 34th Annual
Healthcare Life Sciences Conference . Virtual,February 13-14, 2024 .- Format: Fireside Chat
Presenter:Berndt Modig andMorgan Conn , Ph.D.
Date, time:Wednesday, February 14, 2024 ,8:30-9:10 a.m. EST
- Format: Fireside Chat
American Academy of Allergy , Asthma & Immunology (AAAAI) 2024 Annual Meeting.Washington, DC ,February 23-26, 2024 . Details for the accepted poster presentations at AAAAI are as follows:- Title: Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Oral Deucrictibant in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 Trial
Presenter:Marc A. Riedl , M.D., M.S.
Date, time:Friday, February 23, 2024 ,3:15-4:15 p.m. EST - Title: Understanding the Reasons not to Treat All HAE Attacks and Patient Satisfaction for on-Demand Treatment (ODT). Results from the HAE Wave II Disease Specific Program™ (DSP™) 2023.
Presenter:Joan Mendivil , M.D.
Date, time:Friday, February 23, 2024 ,3:15-4:15 p.m. EST
- Title: Efficacy and Safety of Bradykinin B2 Receptor Antagonism with Oral Deucrictibant in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 Trial
Live audio webcasts of the J.P. Morgan and Oppenheimer presentations will be available on the Investors section of the
About Deucrictibant
Deucrictibant is a potent, selective, and orally available antagonist of the bradykinin B2 receptor. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to treat the clinical signs of an HAE attack and to prevent the occurrence of attacks. Based on its chemical properties,
About
Building on its deep-seated roots in HAE,
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 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
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ContactMaggie Beller Executive Director, Head ofExternal and Internal Communications maggie.beller@pharvaris.com
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