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ZUG, Switzerland, July 10, 2021 (GLOBE NEWSWIRE) – Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on the development and commercialization of novel oral bradykinin B2 receptor antagonists for the treatment of angio- Hereditary edema (HAE) and other indications mediated by bradykinin-B2 receptors, today announced the presentation of clinical data supporting the multiple dose safety and pharmacokinetic (PK) profile of PHA121 (PHA-022121 ) for the treatment of hereditary angioedema (HAE) at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2021, to be held virtually July 10-16, 2021.
The double-blind, randomized, placebo-controlled, multiple-dose escalating study included 38 healthy male and female volunteers. PHA121 was administered orally after standardized twice-daily (BID) meals for 10 days in four sequential dose cohorts, ranging from 12 to 50 mg, with safety and pharmacokinetic evaluations during treatment and follow-up for 72 hours after the last dose. PHA121 was well tolerated up to the highest dose of 50 mg BID. All of the treatment-related adverse events (TREs) reported were mild and resolved completely. The total incidence and type of AEs were comparable between the active and placebo groups.
The data also show that PHA121 was well absorbed with median times to peak plasma concentrations within 1.00 to 1.75 hours after administration with standard meals. On day 1 and day 10, plasma exposure of PHA121 increased approximately dose-proportionally over the dose range of 12 to 50 mg with a mean half-life ranging from 4.8 to 7.3 hours after day. 10. At steady state, which was generally achieved within three days of treatment, plasma PHA121 levels remained consistently above the EC85 therapeutic threshold for all doses (as determined by human bradykinin challenge described above).
“The pharmacokinetic profile demonstrated in this study suggests that the therapeutic effect of PHA121 can be achieved from the first day of administration, with steady state plasma levels achieved within three days. PHA121 was well tolerated in healthy volunteers up to 50 mg given twice daily for 10 days, â€said Peng Lu, MD, Ph.D., chief medical officer of Pharvaris. “Combined with our bradykinin challenge data, which showed potent inhibition of bradykinin-induced hemodynamic effects, the pharmacokinetic and safety data observed in this study support future development to assess the efficacy and safety of prophylactic use of PHA121 in patients with HAE. “
Berndt Modig, CEO and co-founder of Pharvaris, added: “Bradykinin-B2 receptor antagonism has been shown to be effective in the treatment of acute HAE attacks, but is currently not available as an oral treatment. . Pharvaris remains committed to providing patients with oral alternatives for both on-demand and prophylactic HAE therapy through our soft capsule formulation, PHVS416, and prolonged-release tablet formulation, PHVS719.
A copy of the electronic poster, titled “Multiple Dose Administration of PHA-022121, an orally available bradykinin B2 receptor antagonist is well tolerated and has a favorable pharmacokinetic profile for the prophylactic treatment of HAE”, can be found in the Investors section of the Company’s website at https://ir.pharvaris.com/news-events/events-presentations.
About PHVS416 PHVS416 is a capsule containing PHA121, a highly potent, specific and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide rapid exposure to an attack alleviating drug in a convenient small oral dosage form. PHVS416 is currently in phase 2 clinical development for the on-demand treatment of HAE.
About PHVS719 PHVS719 is an extended-release tablet formulation containing PHA121, a highly potent, specific and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide prolonged exposure to an attack prevention drug in a convenient small oral dosage form. PHVS719 is currently in preclinical development for the prophylactic treatment of HAE.
About PHA121 PHA121 (PHA-022121) is a highly potent, specific, and orally bioavailable competitive bradykinin B2 receptor antagonist that has completed Phase 1 clinical development for the treatment of HAE. PHA121 uses the same mechanism as icatibant, the main treatment for the on-demand treatment of HAE. Pharvaris is developing this new small molecule for the on-demand and prophylactic treatment of HAE and other bradykinin-mediated diseases through formulations optimized for each context.
About Pharvaris Pharvaris is a clinical-stage company focused on providing oral bradykinin B2 receptor antagonists to patients. By targeting this clinically proven therapeutic target with new small molecules, the Pharvaris team offers new alternatives to injected therapies for all HAE subtypes and other bradykinin-induced diseases. The Company brings together executives with extensive expertise in pharmaceutical development and rare diseases, including HAE. For more information, visit https://pharvaris.com/.
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 historical facts should be considered as forward-looking statements, including, without limitation, statements containing the words “believe”, “anticipate”, “s ‘expect’, ‘estimate’, ” may ‘,’ could ‘,’ should ‘,’ would ‘,’ will intend ‘,’ intend ‘and similar expressions. These forward-looking statements are based on management’s current expectations, are not promises or guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements. of Pharvaris significantly different from its expectations expressed or implied by forward-looking statements. Such risks include, but are not limited to: the timing, progress or expected success of our clinical development programs, particularly for PHVS416 and PHVS719, which are in the early stages of clinical trials; the risks associated with the COVID-19 pandemic, which could have a negative impact on our activities, preclinical studies and clinical trials; the timing of regulatory approvals; the value of our common shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidates that we may develop in the future; our ability to build business 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 generics; our ability to market, market and gain 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 to operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage the negative consequences of changes in applicable laws and regulations, including tax laws, our ability to successfully remedy material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control on financial information; and other factors described under “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 contained in this press release. These 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. Although Pharvaris may choose to update these 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 taken as representing the views of Pharvaris as of any date subsequent to the date of this press release.
Investor Contact Sarah McCabe Stern Investor Relations, Inc. + 1-212-362-1200 sarah.mccabe@sternir.com
Media Contact Maggie Beller Russo Partners, LLC + 1-646-942-5631 maggie.beller@russopartnersllc.com
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