KNG1

ZUG, Switzerland, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced a summary of data being presented at the ongoing 7th Bradykinin Symposium. Details of the presentations are outlined below: Long-Term Safety and Efficacy of Oral Deucrictibant for HAE Prophylaxis, a poster presentation by Marc A. Riedl, M.D., M.S. In the current analysis of the ongoing open-label extension of the CHAPTER-1 Phase 2 study, deucrictibant 40 mg/day was well-tolerated, with no new safety signals observed. The results presented provide evidence of the long-term safety and efficacy of deucrictibant for the prevention of HAE attacks and support further development of deucrictibant as a potential prophylactic therapy for HAE. Results of this analysis provide support that: Continuing deucrictibant treatment sustained the early-onset attack reduction seen in the randomized, placebo-controlled portion of the trial, with a median attack rate of zero for every month for over a year in the open-label part of the studyOn average, less than one attack per year per participant was treated with on-demand medication Treatment of HAE Attacks with Oral Deucrictibant: RAPIDe-2 Extension Results, a poster presentation by Emel Aygören-Pürsün, M.D. In the current analysis of the ongoing RAPIDe-2 Phase 2/3 extension study, deucrictibant immediate release capsule was well-tolerated for all studied doses with no new safety signals observed. Results from the ongoing RAPIDe-2 extension are consistent with the randomized, placebo-controlled RAPIDe-1 Phase 2 study and provide evidence regarding the long-term safety and efficacy of deucrictibant IR capsule for repeat treatment of HAE attacks. Outcome analyses showed: Median time to onset of symptom relief as measured by the Patient Global Impression of Change (PGI-C) was 1.1 hours, with 98.5% of attacks achieving onset of symptom relief by 12 hoursMedian time to reduction in attack severity as measured by the Patient Global Impression of Severity (PGI-S) was 2.6 hours, with 97.7% of attacks achieving reduction in attack severity by 12 hoursMedian time to complete attack resolution as measure by PGI-S was 11.5 hours, with 85.8% of attacks achieving complete attack resolution within 24 hoursOverall, 86.0% of attacks were treated with a single dose of deucrictibant immediate-release capsule Prophylactic Treatment with Deucrictibant Improves HAE Disease Control and HRQoL, an oral presentation by Markus Magerl, M.D. In the randomized, placebo-controlled part of CHAPTER-1, a Phase 2 clinical study of deucrictibant for the prophylactic treatment of HAE attacks, health-related quality of life was evaluated using several measures. In the study, it was demonstrated that deucrictibant treatment led to improvements in disease control versus placebo, with 90% of participants in the deucrictibant-groups demonstrating well-controlled HAE at week 12. Presentation details included: Deucrictibant improved Angioedema Quality of Life Questionnaire (AE-QoL) scores, particularly in “functioning” and “fear/shame” domains compared to placeboDeucrictibant-treated participants reported greater satisfaction than those treated with placebo with regards to effectiveness and the domain of global satisfaction, and a comparable satisfaction for side effects, as measured by Treatment Satisfaction Questionnaire for Medication (TSQM) Deucrictibant vs. Standard of Care in HAE: Propensity Score-Matched Analysis, a poster presentation by Marc A. Riedl, M.D., M.S. A propensity score-matched comparison of clinical outcomes between a subgroup of attacks (N=73) from the RAPIDe-2 study and a subgroup of attacks (N=73) from an observational real-world study treated with standard of care, the outcomes were more favorable for the attacks treated with deucrictibant on PGI-C- and PGI-S-based assessments. Deucrictibant had a shorter (1.07 hours) median time to onset of symptom relief as measured by PGI-C “a little better” compared to standard of care (2.38 hours). Cardiovascular safety of repeated oral administration of the B2-receptor antagonist deucrictibant, a poster presentation by Nieves Crespo, Ph.D. In chronic nonclinical safety studies of deucrictibant in non-human primates, no evident effects on cardiac electrophysiology, morphology and hemodynamic parameters were observed. Deucrictibant has showed no evident effects on cardiac electrophysiology and hemodynamic parameters in clinical studies in humans to date, following prophylactic treatment up to 12 weeks of administration in the randomized, placebo-controlled part of the Phase 2 CHAPTER-1 clinical study and up to one year of mean duration of treatment in the ongoing open-label extension (OLE) part. Prophylaxis of Hereditary Angioedema Attacks with Oral Deucrictibant: CHAPTER-1 Results, a poster presentation by Emel Aygören-Pürsün, M.D. The CHAPTER-1 study demonstrated that deucrictibant may significantly reduce the occurrence of HAE attacks, and clinically meaningful reduction in occurrence of moderate and severe HAE attacks, as well as HAE attacks treated with on-demand medication, was observed. CHAPTER-1 results provide evidence of the efficacy and safety of deucrictibant for the prevention of HAE attacks and support its further development as a potential prophylactic therapy for HAE. Clinical Trials Conformity with AURORA COS: a systematic literature review, a poster presentation by Remy S. Petersen, M.D., Conforming to a core outcome set (COS) across various study designs, such as the COS recommended for HAE clinical studies by the Panel of Experts participating in the AURORA Project, may homogenize the use of specific outcomes for clinical studies and support future indirect comparisons among interventions. The design of the RAPIDe-3 Phase 3 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks fully conforms with the AURORA COS based on its prespecified endpoints. Bradykinin Challenge Model in Humanized Bradykinin B2 receptor Transgenic Rat, an oral presentation by Jolanta Skarbaliene, Ph.D. The bradykinin (BK) challenge model is a tool to assess pharmacokinetic and pharmacodynamic activity of bradykinin B2 receptor antagonists. A BK challenge model was successfully developed in humanized bradykinin B2 receptor transgenic rats that are pharmacologically responsive to bradykinin B2 receptor antagonists. The BK challenge model in humanized bradykinin B2 receptor transgenic rats can offer a valuable, easy to manage, and cost-effective tool for efficacy studies compared to those involving non-human primates. Deucrictibant inhibits carrageenan-induced edema in bradykinin B2 receptor transgenic rat, a poster presentation by Anne Lesage, Ph.D. A humanized bradykinin B2 receptor transgenic rat model was used to address the challenge of deucrictibant species selectivity in experimental models. Oral deucrictibant inhibited carrageenan-induced paw edema in humanized bradykinin B2 receptor transgenic rats. The bradykinin challenge model translates across rat, monkey and human, a poster presentation by Juan Bravo, Ph.D. The pharmacokinetics (PK) and pharmacodynamics (PD) of icatibant were analyzed from BK challenge studies in humanized bradykinin B2 receptor transgenic rats, non-human primates, and healthy volunteers. Analyses across species showed similar responses, demonstrating that the BK challenge model in transgenic rats and non-human primates may be predictive of PK/PD outcomes in humans. A novel kinin biomarker assay for characterization of bradykinin-mediated disorders, a poster presentation by Evangelia Pardali, Ph.D. BK is involved in various physiological and pathological processes, including angioedema (AE). Differentiating BK-mediated from histamine-mediated AE and assessing the role of BK in the pathogenesis of other conditions by measuring kinin peptides remains a challenge due to their proteolytic instability and limitations of current analytical assays. A kinin biomarker assay was established and qualified, which could become a key tool for identifying, studying, and managing BK-mediated diseases. A HMWK capillary immunoblotting assay to characterize bradykinin-mediated disorders, a poster presentation by Evangelia Pardali, Ph.D. Activation of the plasma kallikrein-kinin system (KKS) can result in cleavage of high molecular weight kininogen (HMWK) and production of vasodilatory kinins, such as BK. A HMWK immunoblotting assay was established and qualified to reliably measure KKS biomarkers in human plasma and could become a key tool for identifying, studying, and managing BK-mediated diseases. The presentation slides and posters are available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. About DeucrictibantDeucrictibant is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to prevent the occurrence of HAE attacks and to treat the manifestations of attacks if they occur. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy for prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. About PharvarisPharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of bradykinin-mediated angioedema effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both prophylactically and on-demand . With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks in the coming months. 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; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 studies in ongoing and future nonclinical studies and 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 outcome and 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, 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, including with respect to existing therapies, emerging potentially competitive therapies 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.

PRESS RELEASE Memo Therapeutics increases Series C financing to CHF 45 million Additional CHF 20 million raised from new investors Ysios Capital and Kurma Partners as well as from existing investors Proceeds will be used to expand Phase II of best-in-class anti-BK Virus antibody to become the largest study ever conducted for BK virus infection in kidney transplantation Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million. The new funding will be used to bolster the clinical advancement of MTx’s lead asset, AntiBKV, expanding the Phase II trial with a dose evaluation extension to be the largest BK viremia therapeutic study ever conducted in kidney transplant recipients. The disease represents a potential market in excess of $1 billion and is caused by the BK virus, which can become reactivated in immunosuppressed kidney transplant patients leading to severe complications. Initial data from the Phase II trial is expected in the first half of 2025. The funding will further support the development of MTx’s pipeline by leveraging its B-cell screening platform to select best-in-class humanized antibodies in other viral infections and oncology. Erik van den Berg, CEO of Memo Therapeutics, commented: “This financing provides further external endorsement of the potential of our highly potent anti-BK virus mAb and our clinical strategy to bring it to patients as quickly as possible. There are more than 100,000 kidney transplants worldwide each year and 20,000 of these are at risk from developing BK virus associated nephropathy. With no disease modifying therapies available, there is an urgent need for a treatment. With FDA fast track status already obtained for the product, we look forward to rapidly progressing the development of AntiBKV.” New investors Ysios Capital and Kurma Partners participated in the extension round, joining existing Series C round investors including Pureos Bioventures, Swisscanto, Vesalius Biocapital, Adjuvant Capital, Verve Ventures, Schroders Capital, GF Group, Fresenius Medical Care Ventures and Red Alpine. Thomas Harth, Principal at Ysios Capital stated: “We believe Memo Therapeutics has developed a very powerful antibody that can address the growing concern of BKV infections in kidney transplant recipients. By being able to preserve the kidney and ensure graft outcome, this antibody could offer a tremendous benefit to patients. Deriving antibodies in screening of the B-cell repertoire offers a route to best-in-class antibody medicines for multiple diseases. We believe MTx has one of the best engines to do so within the industry. We are encouraged to support MTx in its mission to address the unmet medical need of BK viremia and beyond. MTx fits strongly with the investment strategy at Ysios to support breakthrough medicines.” Hadrien Bouchez, Partner at Kurma Partners added: “MTx has an exceptional leadership team with a proven track record of success. We are very excited to support the development of AntiBKV, an agent which has a unique efficacy and safety profile. Our investment underscores our commitment to supporting companies that are poised to make a significant impact on global healthcare.” Thomas Harth, Principal at Ysios Capital and Hadrien Bouchez, Partner at Kurma Partners will join the Memo Therapeutics Board of Directors. Alongside AntiBKV, Memo Therapeutics is developing a panel of pre-clinical assets in cancer and viral infections. These are based on the ability of MTx’s antibody discovery platform DROPZYLLA®, to interrogate the antibodyomes of elite controllers of infection and cancer. -Ends- Contacts Memo Therapeutics AG info@memo-therapeutics.com ICR ConsiliumAmber Fennell, Ashley Tappmemotx@consilium-comms.com+44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG (“MTx”) is a late-stage biotech company developing best-in-class therapeutic antibodies to transform the lives of patients with viral infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients. This infection can lead to nephropathy, loss of kidney function, as well as organ failure and rejection. MTx’s pipeline consists of additional candidate therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus (“CMV”), immuno-oncology targets alone and in partnership with Ono Pharmaceutical. MTx is a private company located in Schlieren / Zurich, Switzerland. About BK VirusBKV infection occurs mostly in childhood and remains dormant in healthy individuals. However, BKV infection poses a significant threat following kidney transplantation, with serious adverse effects on graft function, kidney failure and ultimately patient survival. Due to the immunosuppressive drug regimen transplant patients receive, reactivation of BKV is triggered in approx. 40% of kidney transplant recipients, with 20% experiencing systemic virologically exposure. Up to 10% then progress to BKV associated nephropathy, which is the leading cause of graft loss. There is currently no disease modifying therapy available to treat BKV infection; it can only be addressed by lowering immunosuppression. However, this significantly increases the risk of a graft rejection reaction, also leading to impaired functionality and longevity, or graft failure. About Ysios Capital Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage, highly innovative life science companies bringing life-changing treatments to patients, with a focus on indications with high unmet need. They have a diverse international team in San Sebastián and Barcelona, driven by science, with the ambition to transform capital into medical breakthroughs. Ysios Capital was founded in 2008 and has over $450 million in assets under management through its three funds. About Kurma Partners Kurma Partners is a key European player in the financing of innovation in Healthcare and Biotechnology, from pre-seed to growth capital, in particular through its funds Kurma Biofund I, II, III, IV, Kurma Growth, Kurma Diagnostics and Kurma Diagnostics 2, as well as the links the company has forged with a network of prestigious research institutes and hospitals. Kurma Partners was founded in July 2009 and is based in Paris and in Munich.

Astria Therapeutics Announces Publication of STAR-0215 Preclinical Data in the Journal of Pharmacology and Experimental Therapeutics BOSTON--(BUSINESS WIRE)-- Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced that preclinical data supporting STAR-0215’s pro a potential long-acting therapy for hereditary angioedema (HAE) dosed once every three or six months has been published in the Journal of Pharmacology and Experimental Therapeutics. “We were very pleased by our publication in the Journal of Pharmacology and Experimental Therapeutics, further validating the exciting science behind STAR-0215,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “These results demonstrate that STAR-0215 is a potential best-in-class plasma kallikrein inhibitor as it shows high potency in vitro and in vivo and long half-life, suggesting potential for sustained, durable HAE attack suppression with subcutaneous administration.” Overview of STAR-0215 Preclinical Results: STAR-0215’s YTE modification in the Fc domain enhances FcRn receptor binding, resulting in a ~3-fold prolonged half-life in cynomolgus monkeys compared to antibodies without this modification. STAR-0215 has a >1000-fold lower affinity for prekallikrein and no measurable inhibitory activity against other serine proteases, demonstrating potent and specific binding for STAR-0215 for human plasma kallikrein. STAR-0215 demonstrated potent in vitro inhibition of plasma kallikrein-mediated bradykinin release from high molecular weight kininogen (HWMK) in a physiologically relevant assay. STAR-0215 achieved inhibition of cleaved HMWK (cHMWK) in cynomolgus monkeys within one day after dosing. This inhibition was sustained throughout the duration of the study, including an 84-day dose-free period, demonstrating both rapid and long-lasting inhibition of plasma kallikrein achievable by subcutaneous administration. The publication can be found at the following link: STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE. Initial results from a Phase 1a trial in healthy subjects support STAR-0215’s target profile: a long-acting preventative therapy, best-in-class pharmacokinetic (PK) profile, and dosing once every three or six months. Final results from these three cohorts, as well as initial results from two additional cohorts, are anticipated in the fourth quarter of 2023. The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in people living with HAE is ongoing, with initial proof-of-concept results from single and multiple dose cohorts expected in mid-2024. About Astria Therapeutics: Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Learn more about our company on our website, , or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn. Forward Looking Statements: This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: expectations regarding the timing and nature of additional results from the ongoing STAR-0215 Phase 1a clinical trial; the timing and nature of the anticipated proof of concept results from the ALPHA-STAR Phase 1b/2 clinical trial; the potential attributes and differentiated pro STAR-0215 as a treatment for HAE, and our vision for STAR-0215 as a treatment for HAE; the need for effective treatments for HAE; the potential for three and six-month administration of STAR-0215; and our goal to meet the unmet needs of patients with rare and niche allergic and immunological diseases. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goals,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Company’s product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors, including the COVID-19 pandemic; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of pre-clinical studies may not be replicated in clinical studies, that the preliminary results from the Phase 1a trial may not be indicative of the final results, that the results of early stage clinical studies, such as the preliminary and initial unblinded results from the Phase 1a trial, may not be replicated in later stage clinical studies, including the ALPHA-STAR trial, the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the FDA and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to STAR-0215 and any other future development candidates; the risk that we do not realize some or all of the potential benefits of STAR-0215's Fast Track designation; our ability to manufacture sufficient quantities of drug substance and drug product for STAR-0215 and any other future product candidates on a cost-effective and timely basis, and to develop dosages and formulation for STAR-0215 and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefore; our ability to obtain, maintain and enforce intellectual property rights for STAR-0215 and any other future product candidates; our potential dependence on collaboration partners; competition with respect to STAR-0215 or any of our other future product candidates; the risk that the clinical results to date, survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of STAR-0215 to compete in HAE and the anticipated position and attributes of STAR-0215 in HAE based on its clinical data to date, pre-clinical profile, mechanistic and other modeling, market research, patient feedback and other data; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the “Risk Factors” section of our Annual Report on Form 10-K for the period ended December 31, 2022 and in other filings that we make with the Securities and Exchange Commission (“SEC”). New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. The Company may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on the Company’s forward-looking statements. Neither the Company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.