A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis

Start Date28 May 2020

Sponsor / Collaborator-

NCT04195906 / CompletedPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SNF472 When Added to Background Care for the Treatment of Calciphylaxis

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

Start Date12 Feb 2020

Sponsor / Collaborator

Sanifit Therapeutics SA

EUCTR2016-002834-59-ES / Not yet recruitingPhase 2

A double-blind, randomised, placebo-controlled study to assess the effect of SNF472 on progression of cardiovascular calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on haemodialysis (HD)

Start Date16 Nov 2016

Sponsor / Collaborator-

100 Clinical Results associated with Hexasodium phytate

100 Translational Medicine associated with Hexasodium phytate

100 Patents (Medical) associated with Hexasodium phytate

137

Literatures (Medical) associated with Hexasodium phytate

01 Oct 2024·Journal of Colloid and Interface Science

Effect of cross-linking density on the rheological behavior of ultra-soft chitosan microgels at the oil–water interface

Article

Author: Zhen, Shiyu ; Kong, Songmei ; Yang, Nan ; Li, Zhenzhen ; Sun, Fusheng ; Ma, Xuxi

In this paper, microgels with uniform particle size were prepared by physically cross-linking the hydrophobically modified chitosan (h-CS) with sodium phytate (SP). The effects of cross-linking density on the interfacial adsorption kinetics, viscoelasticity, stress relaxation, and micorheological properties of the hydrophobically modified chitosan microgels (h-CSMs) at the oil-water interface were extensively investigated by the dilatational rheology, compressional rheology, and particle tracing microrheology. The results were correlated with the particle size, morphology, and elasticity of the microgels characterized by dynamic light scattering and atomic force microscopy. It was found that with the increase of cross-linking density, the h-CSMs changed from a polymer-like state to ultra-soft fussy spheres with higher elastic modulus. The compression isotherms demonstrated multi-stage increase caused by the interaction between the shells and that between the cores of the microgels successively. As the increase of cross-linking density, the h-CSMs diffused slower to the oil-water interface, but demonstrating faster permeation adsorption and rearrangement at the oil-water interface, finally forming interfacial layers of higher viscoelastic modulus due to the core-core interaction. Both the initial tension relaxation and the microgel rearrangement after interface expansion became faster as the microgel elasticity increased. The interfacial microrheology demonstrated dynamic caging effect caused by neighboring microgels. This article provides a more comprehensive understanding of the behaviors of polysaccharide microgels at the oil-water interface.

01 Oct 2024·International Journal of Toxicology

Safety Assessment of Polyol Phosphates as Used in Cosmetics

Review

Author: Klaassen, Curtis D. ; Fiume, Monice ; Shank, Ronald C. ; Slaga, Thomas J. ; Bergfeld, Wilma F. ; Johnson, Wilbur ; Heldreth, Bart ; Marks, James G. ; Liebler, Daniel C. ; Snyder, Paul W. ; Belsito, Donald V. ; Hill, Ronald A.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 polyol phosphates. Some of the possible functions in cosmetics that are reported for this ingredient group are chelating agents, oral care agents, and skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that Sodium Phytate, Phytic Acid, Phytin, and Trisodium Inositol Triphosphate are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the data are insufficient to determine the safety of the following 6 ingredients as used in cosmetics: Disodium Glucose Phosphate, Manganese Fructose Diphosphate, Sodium Mannose Phosphate, Trisodium Fructose Diphosphate, Xylityl Phosphate, and Zinc Fructose Diphosphate.

01 Sep 2024·eClinicalMedicine

Hexasodium fytate for the treatment of calciphylaxis: a randomised, double-blind, phase 3, placebo-controlled trial with an open-label extension

Article

Author: Nigwekar, Sagar U. ; Brandenburg, Vincent ; Aronoff, George R ; Serena, Thomas E. ; Moe, Sharon M ; Perelló, Joan ; Aronoff, George R. ; Serena, Thomas E ; Carroll, Kevin J ; Chatoth, Dinesh K. ; Chatoth, Dinesh K ; Gold, Alex ; Keller, Laurence H. ; Keller, Laurence H ; Nigwekar, Sagar U ; Alperovich, Gabriela ; Hymes, Jeffrey L. ; Sinha, Smeeta ; Carroll, Kevin J. ; Hymes, Jeffrey L ; Chertow, Glenn M. ; Moe, Sharon M. ; Chertow, Glenn M ; Gould, Lisa J. ; Gould, Lisa J

BackgroundIn the CALCIPHYX trial, we investigated hexasodium fytate, an inhibitor of vascular calcification, for the treatment of calcific uraemic arteriolopathy (calciphylaxis), a rare condition characterised by painful, non-healing skin lesions.MethodsIn this international, phase 3, randomised, double-blind, placebo-controlled trial, adults with an ulcerated calciphylaxis lesion and pain visual analogue scale (VAS) score ≥50/100 were randomised 1:1 to hexasodium fytate 7 mg/kg or placebo intravenously during maintenance haemodialysis. Primary efficacy outcomes were an 8-item modification of the Bates-Jensen Wound Assessment Tool (BWAT-CUA) and Pain VAS in the intention-to-treat population. ClinicalTrials.gov number: NCT04195906.FindingsOverall, 34/37 patients randomised to hexasodium fytate and 26/34 patients randomised to placebo completed the 12-week randomised treatment period. At Week 12, both groups (hexasodium fytate versus placebo) showed similar improvements in BWAT-CUA (mean [standard deviation (SD)], -5.3 [5.2] versus -6.0 [6.2]; least squares mean difference, 0.3 [96% confidence interval (CI): -2.5, 3.0]; p = 0.88) and Pain VAS (mean [SD], -19.5 [26.9] versus -32.2 [38.5]; least squares mean difference, 11.5 [96% CI: -4.8, 27.8]; p = 0.15). One patient randomised to placebo briefly received hexasodium fytate in error. Serious adverse events through Week 12 included: calciphylaxis-related events leading to hospitalisation (2/38 [5%] versus 11/33 [33%]) and death (1/38 [3%] versus 5/33 [15%]). During the subsequent 12 weeks of open-label hexasodium fytate and 4 weeks of follow-up, there were no additional calciphylaxis-related events leading to hospitalisation. Over the course of the entire trial, deaths were 2/38 [5%] for the hexasodium fytate group and 7/33 [21%] for the placebo group.InterpretationIn patients with calciphylaxis, BWAT-CUA and Pain VAS improved similarly in hexasodium fytate- and placebo-treated patients; over the course of the entire trial, there were fewer deaths and calciphylaxis-related events leading to hospitalisation in the hexasodium fytate group.FundingFunded by Sanifit, a CSL Vifor company.

News (Medical) associated with Hexasodium phytate

29 Mar 2023

·endpts.com

Q&A: Newly-minted CSL chief executive Paul McKenzie and chief medical officer Bill Mezzanotte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault. With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript. Endpoints: You took over this month as CEO from long-time CSL veteran Paul Perreault — in what ways are you going to move the company into new areas, and what have you learned from what Mr. Perreault as he led CSL over the last decade? McKenzie : It’s a real privilege to be able to be given this opportunity to work with this fantastic management team. That dedication and promise we have to patients and from my first interaction with CSL, that was critically important. From Paul, that passion, he knows some of the patients in hemophilia by first name, and that’s something that won’t change. What I also learned was that as the organization grows larger, is to really focus. It’s easy to do lots of things, and harder to do a few things very well. As a management team we spent a lot of time, as we came and dealt with Covid, on focus and making sure everyone in the organization understands where we need to be and where we need to put our efforts. That doesn’t mean ideas aren’t welcome, but not every idea can be prosecuted on a given day. Right now we’re focused on our journey to sustainable and profitable growth and that requires us to reestablish firmly our leadership in the plasma market, requires us to continue to drive our R&D portfolio and interest and desire in differentiating. It’s not like we have a big change in strategy. As a management team we have great continuity; we’re firmly rooted in our CSL 2030 strategy, and a year or two out, we’ll start working on our 2035 and 2040. Endpoints : You recently won approval for the world’s first gene therapy for hemophilia B — Hemgenix. How competitive is this space going to be in the near term? And when you look at the data Pfizer released in December, is there a concern that this market isn’t big enough for two $3 million-plus gene therapies? McKenzie : What we know is our data and our data look fantastic. We’re an AAV5 platform out of the partnership with uniQure, and continue to see good durability. We set a high bar. AAV5 is unique in our ability to dose even though people may have antibodies prior to AAV5, which is very differentiated from the AAV8 or AAV9 historic platforms. We’re very bullish in our ability to make a real difference for patients that want to have a solution other than the standard of care, [CSL’s] Idelvion. Mezzanotte : Every area we’re in has healthy competition and Pfizer has great scientists, but we’re quite happy with the molecule we have, the data we’ve generated and of course the commercial experience we have. Endpoints : Can you say anything about the uptake or interest in Hemgenix since its approval? Mezzanotte : There’s substantial interest and we’ve already had physicians in the US write prescriptions. However, this is gene therapy, not a pill, so there’s work with the payers to ensure reimbursement and that the sites are going through the process right so the dose is administered correctly. Obviously you don’t want to mess up the dosage of an expensive therapy. We expect very soon to be able to report that patients have been dosed. But I can tell you around the world there’s a lot of interest. I was just in Japan, and I was interviewed there about Hemgenix. Endpoints : How have payers reacted to the list price of $3.5 million, and has it been a barrier to access? McKenzie : In the US, the ICER report really looked at the overall burden of disease and showed this to be a very effective treatment. In the US, we’ve had good rapport, and good discussions relative to reimbursement. Not a lot of differentiation of the model. More of, “Hey, is it the right patient, can they be successful?” And in the other parts of the world, there’ll be different business models that likely will have to be implemented to ensure this is a durable product for patients. We’ll listen and be attentive to what the different countries we need, but I think in the US, the discussions have been in the right direction and firmly based on the ICER data. Mezzanotte : I was just at an R&D meeting and the general sentiment was we want to figure out a way to pay for these therapies. These are the future. I think they’re playing with a variety of models on how to do that, but I sat in on some meetings with payers and there really isn’t pushback on the drug, and there are questions on pricing, but we’re having good discussions and because of our history in hemophilia, we have relationships with them. Endpoints : Looking at your Phase III pipeline, what assets are you most excited about and going to be seeing readouts in the nearest future? McKenzie : I shook up my colleagues by saying at our investor day that we had a number in there that I thought could be standard of care in the future if they have the data we hope. Obviously the number one coming out is garadacimab, an anti-FXIIa monoclonal antibody, which showed great Phase III efficacy and tolerability data, and we’ll be filing that this year as a potential treatment of hereditary angioedema (HAE) by subcutaneous administration. We’re still excited about CSL112, our apoA-I product for patients who have suffered a heart attack; those data will be coming out next year. And one we haven’t talked about as much but I remain excited about, and we’ll be seeing data at some point this year or maybe early next, is [CSL964,] an alpha-1 antitrypsin, which is being tested in both prevention and treatment of graft versus host disease. From the Vifor side, very soon, by the first half of this year we should have data on SNF472, which actually came from a little company in Spain. This is a quite impactful drug if it works. Mezzanotte : On flu, aQIVc (Adjuvanted Cell Culture Influenza Vaccine) takes the best of our cell technology, Flucelvax, with our adjuvant [MF59] to bring the next standard of care in flu. That will start in Phase III clinical trials in this Northern Hemisphere campaign and we really think that will be the next bar that people will compare to non-egg-based adjuvanted product offering, which continues our differentiation journey. And then beyond that is the differentiation built around self-amplifying mRNA.

Phase 3Executive ChangeVaccineClinical ResultGene Therapy

02 Nov 2022

·www.prnewswire.com

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa., Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health. CSL revealed progress and plans in advancing assets that have the potential to disrupt current standards of care in its areas of focus (immunology, haematology, respiratory, cardiovascular and metabolic, transplant, nephrology, vaccines) using its strategic scientific platforms (plasma protein technology, recombinant technology, cell and gene therapy, and sa-mRNA, adjuvanted, cell-based and egg-based vaccines). Among the highlights presented were the following: Late-Stage Development Includes Disruptive Innovation and New Additions to the CSL Portfolio Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). If approved, etranacogene dezaparvovec would be the first-ever gene therapy treatment option for the haemophilia B community. The regulatory filings are supported by results from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The multi-year clinical development program for etranacogene dezaparvovec was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials has transitioned to CSL after acquiring global rights to commercialize the investigational treatment. Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. CSL aims to begin filing for approval with global regulatory authorities next calendar year. Garadacimab was discovered and optimised by scientists at CSL's Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. CSL Vifor brings a leading portfolio of therapies in nephrology, dialysis and iron deficiency. New late-stage assets to the pipeline include Sparsentan for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) and SNF472 for calciphylaxis and calcific uremic arteriolopathy (CUA). R&D Portfolio Progress Across Areas of Focus and Scientific Platforms Clazakizumab, an anti-IL6 monoclonal antibody, intended for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients continues to progress in the Phase III IMAGINE trial. This is CSL's leading program for clazakizumab, which will also be investigated in a Phase IIb/III study for improvement of cardiovascular (CV) outcomes in dialysis patients. CSL plans to engage Fresenius Medical Care dialysis centres in the study. AEGIS-II, a Phase III, multicenter, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112, compared to placebo, in reducing the risk of major adverse CV events (MACE) in patients following a heart attack, will enrol the last patient by the end of 2022, with completion of the trial expected towards the end of 2023. CSL is advancing the Phase IIb study for its adjuvanted, cell-based high-dose quadrivalent influenza vaccine (aQIVc). This study will help CSL further build the body of clinical evidence to support the optimal formulation for when the company moves into the Phase III immunogenicity and safety study for aQIVc. Published results from the preclinical studies of CSL's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines, indicate a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). CSL's sa-mRNA candidate is expected to enter clinical trials in 2023. Recently Announced Collaboration and license agreement with Arcturus Therapeutics aims to accelerate next-generation mRNA capabilities in influenza, pandemic preparedness and other selected respiratory viral pathogens -- including a near term COVID-19 vaccine that has recently reported interim results from a large Phase III efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favourable safety profile. A strategic option and license agreement with Translational Sciences to license TS23, a first-in-class anti-α2-antiplasmin monoclonal antibody. TS23 is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS). The treatment candidate is soon to be evaluated in the US in the NAIL-IT Phase II study, which has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with sub-massive (intermediate risk) PE. "CSL is on the leading-edge of innovation in areas we know well and we have strategically and methodically built a pipeline that has never been more robust with diverse sources of innovation, from in-house and external sources, that include the disruptive scientific platforms of gene therapy and sa-mRNA," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, and Chief Medical Officer for CSL. "Our enhanced capabilities across all of our scientific platforms and therapeutic focus areas will help us in our relentless pursuit to deliver on our promise to help patients lead full lives, protect public health and sustainably grow our business in the decades ahead, while providing promising futures for our employees." In fiscal year 2021-2022, CSL invested approximately $1.16 billion in R&D. This includes growing CSL R&D's footprint in Melbourne, Australia; Marburg, Germany; throughout Switzerland and Waltham, Massachusetts – helping to create an integrated global organization that can conveniently collaborate with institutions everywhere -- offering scientists a wide array of opportunities for professional development and enhancing access to external innovation. Advancing External Innovation: The Biotechnology Incubator at CSL's Global Headquarters in Melbourne, Australia Names Its Operator CSL, WEHI and The University of Melbourne have appointed Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL's new global headquarters currently under construction in the Melbourne Biomedical Precinct. The appointment follows the project partners joining forces to create an incubator for biotech start-up companies, with the Victorian Government's landmark Breakthrough Victoria Fund providing funding to support the AU$95 million project. It will be Australia's first and only incubator that is co-located with a leading biopharmaceutical company and will have space for up to 40 start-ups. "Incubator residents will be working in an innovation-driven environment alongside a large and focused CSL R&D team, enabling opportunities for peer-collaboration, learning and sharing of ideas," said Dr. Andrew Nash, CSL's Chief Scientific Officer and Senior Vice President, Research. "The strong collaboration between CSL, the University of Melbourne, WEHI, Breakthrough Victoria and now Cicada Innovations has been critical to bring the incubator to fruition and reflects CSL's values and desire to deliver on our promise to patients worldwide." For more about the incubator, . For more on CSL's R&D Investor Briefing, please visit . About CSL CSL Limited (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs more than 30,000 people. Our unique combination of commercial strength, R&D focus, and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information visit . Media Contacts: Greg Healy Email: [email protected] +1 610 906 4564 In Australia: Jimmy Baker Email: [email protected] +61 450 909 211 Kim O'Donohue Email: [email protected] +61 449 884 603 In Europe: Jasmin Joller Email: [email protected] SOURCE CSL

VaccineCollaborateGene TherapyAntibodyFinancial Statement

02 Nov 2022

·www.biospace.com

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa., Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health. CSL revealed progress and plans in advancing assets that have the potential to disrupt current standards of care in its areas of focus (immunology, haematology, respiratory, cardiovascular and metabolic, transplant, nephrology, vaccines) using its strategic scientific platforms (plasma protein technology, recombinant technology, cell and gene therapy, and sa-mRNA, adjuvanted, cell-based and egg-based vaccines). Among the highlights presented were the following: Late-Stage Development Includes Disruptive Innovation and New Additions to the CSL Portfolio Etranacogene dezaparvovec (also known as CSL222), an investigational gene therapy for the treatment of adults with haemophilia B has been accepted for priority review by the United States (US) Food and Drug Administration (FDA) and standard review by the European Medicines Agency (EMA). If approved, etranacogene dezaparvovec would be the first-ever gene therapy treatment option for the haemophilia B community. The regulatory filings are supported by results from the pivotal HOPE-B trial, the largest gene therapy trial in haemophilia B to date. The multi-year clinical development program for etranacogene dezaparvovec was led by uniQure (Nasdaq: QURE) and sponsorship of the clinical trials has transitioned to CSL after acquiring global rights to commercialize the investigational treatment. Top-line Phase III results for garadacimab (CSL312, anti-FXIIa), an investigational first-in-class monoclonal antibody being developed as a long-term preventive treatment for patients with hereditary angioedema, demonstrated that the study met its primary and secondary efficacy objectives and showed favourable safety and tolerability. CSL aims to begin filing for approval with global regulatory authorities next calendar year. Garadacimab was discovered and optimised by scientists at CSL's Bio21–based Research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. CSL Vifor brings a leading portfolio of therapies in nephrology, dialysis and iron deficiency. New late-stage assets to the pipeline include Sparsentan for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) and SNF472 for calciphylaxis and calcific uremic arteriolopathy (CUA). R&D Portfolio Progress Across Areas of Focus and Scientific Platforms Clazakizumab, an anti-IL6 monoclonal antibody, intended for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients continues to progress in the Phase III IMAGINE trial. This is CSL's leading program for clazakizumab, which will also be investigated in a Phase IIb/III study for improvement of cardiovascular (CV) outcomes in dialysis patients. CSL plans to engage Fresenius Medical Care dialysis centres in the study. AEGIS-II, a Phase III, multicenter, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112, compared to placebo, in reducing the risk of major adverse CV events (MACE) in patients following a heart attack, will enrol the last patient by the end of 2022, with completion of the trial expected towards the end of 2023. CSL is advancing the Phase IIb study for its adjuvanted, cell-based high-dose quadrivalent influenza vaccine (aQIVc). This study will help CSL further build the body of clinical evidence to support the optimal formulation for when the company moves into the Phase III immunogenicity and safety study for aQIVc. Published results from the preclinical studies of CSL's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates, the next generation of mRNA vaccines, indicate a potent, cross-reactive immune response against pandemic and seasonal influenza strains, A(H5N1) and A(H1N1). CSL's sa-mRNA candidate is expected to enter clinical trials in 2023. Recently Announced Collaboration and license agreement with Arcturus Therapeutics aims to accelerate next-generation mRNA capabilities in influenza, pandemic preparedness and other selected respiratory viral pathogens -- including a near term COVID-19 vaccine that has recently reported interim results from a large Phase III efficacy study, meeting its primary and secondary endpoints of prevention of infection and severe disease with a favourable safety profile. A strategic option and license agreement with Translational Sciences to license TS23, a first-in-class anti-α2-antiplasmin monoclonal antibody. TS23 is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS). The treatment candidate is soon to be evaluated in the US in the NAIL-IT Phase II study, which has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with sub-massive (intermediate risk) PE. "CSL is on the leading-edge of innovation in areas we know well and we have strategically and methodically built a pipeline that has never been more robust with diverse sources of innovation, from in-house and external sources, that include the disruptive scientific platforms of gene therapy and sa-mRNA," said Dr. Bill Mezzanotte, Executive Vice President, Head of R&D, and Chief Medical Officer for CSL. "Our enhanced capabilities across all of our scientific platforms and therapeutic focus areas will help us in our relentless pursuit to deliver on our promise to help patients lead full lives, protect public health and sustainably grow our business in the decades ahead, while providing promising futures for our employees." In fiscal year 2021-2022, CSL invested approximately $1.16 billion in R&D. This includes growing CSL R&D's footprint in Melbourne, Australia; Marburg, Germany; throughout Switzerland and Waltham, Massachusetts – helping to create an integrated global organization that can conveniently collaborate with institutions everywhere -- offering scientists a wide array of opportunities for professional development and enhancing access to external innovation. Advancing External Innovation: The Biotechnology Incubator at CSL's Global Headquarters in Melbourne, Australia Names Its Operator CSL, WEHI and The University of Melbourne have appointed Cicada Innovations as the independent operator of the new biotech incubator which will be located in CSL's new global headquarters currently under construction in the Melbourne Biomedical Precinct. The appointment follows the project partners joining forces to create an incubator for biotech start-up companies, with the Victorian Government's landmark Breakthrough Victoria Fund providing funding to support the AU$95 million project. It will be Australia's first and only incubator that is co-located with a leading biopharmaceutical company and will have space for up to 40 start-ups. "Incubator residents will be working in an innovation-driven environment alongside a large and focused CSL R&D team, enabling opportunities for peer-collaboration, learning and sharing of ideas," said Dr. Andrew Nash, CSL's Chief Scientific Officer and Senior Vice President, Research. "The strong collaboration between CSL, the University of Melbourne, WEHI, Breakthrough Victoria and now Cicada Innovations has been critical to bring the incubator to fruition and reflects CSL's values and desire to deliver on our promise to patients worldwide." For more about the incubator, . For more on CSL's R&D Investor Briefing, please visit . About CSL CSL Limited (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs more than 30,000 people. Our unique combination of commercial strength, R&D focus, and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information visit . In Europe: Jasmin Joller Email: jasmin.joller@cslbehring.com Company Codes: Australia:CSL, OTC-PINK:CSLLY, OTC-BB:CSLLY

VaccineCollaborateGene TherapyAntibodyFinancial Statement

100 Deals associated with Hexasodium phytate

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Arterial Disease	Phase 3	CH	Vifor Fresenius Medical Care Renal Pharma France S.A.S.	10 Aug 2022
Calcific arteriolopathy due to uremia	Phase 3	CH	Vifor (International) AG	30 Jan 2022
Peripheral arterial occlusive disease	Phase 3	CH	Vifor (International) AG	30 Jan 2022
Calciphylaxis	Preclinical	PL	Sanifit Therapeutics SA	12 Feb 2020
Calciphylaxis	Preclinical	DE	Sanifit Therapeutics SA	12 Feb 2020
Calciphylaxis	Preclinical	US	Sanifit Therapeutics SA	12 Feb 2020
Calciphylaxis	Preclinical	ES	Sanifit Therapeutics SA	12 Feb 2020
Calciphylaxis	Preclinical	BE	Sanifit Therapeutics SA	12 Feb 2020
Calciphylaxis	Preclinical	GB	Sanifit Therapeutics SA	12 Feb 2020
Cardiovascular Abnormalities	Preclinical	US	Sanifit Therapeutics SA	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04195906 (Calciphyx, CTgov)	Phase 3	Calciphylaxis	71	SNF472 (SNF472)	gsjofzroqb(dcoaphjgcj) = osjkchesvj kishezocpu (swdbfjvjgz, aztesiivml - iilsnzjvlu) View more	-	20 Feb 2024
				placebo (Placebo)	gsjofzroqb(dcoaphjgcj) = cyntuucoxf kishezocpu (swdbfjvjgz, gggpcupxjk - fbmatbofhp) View more
NCT02966028 (CaLIPSO, Pubmed \| Clin J Am Soc Nephrol)	Phase 2	-	274	Placebo	wxirjgxmma(pbdnwjskzt) = wpieeypwem wnqjrltkce (ytyomnfjcz, -2.7% - -0.3%)	-	07 Apr 2021
				SNF472 300 mg	wxirjgxmma(pbdnwjskzt) = hwsujnatsm wnqjrltkce (ytyomnfjcz, -2.7% - -0.4%)
NCT02966028 (CaLIPSO, CTgov)	Phase 2	Vascular Calcification \| Kidney Failure, Chronic \| Calcification of coronary artery \| Cardiovascular Abnormalities	274	Placebo (Matching Placebo)	cjteosaioa(difahxdqbj) = nijvvugzar qxwgierzjc (snyiuhzzyf, deovokfwor - sjuydyykpc) View more	-	16 Mar 2021
				SNF472 (SNF472 300 mg)	iersirosfg(slrzyqzwmw) = bojveacbpm lswgmrwgsu (ifpmqbiqad, nlwfebuqyt - yvhaqehjdc) View more
CaLIPSO (ASN2020)	Phase 2	Calcinosis	56	SNF472	(iyebvlaciq) = iisxmcjvut ybrvhwaipu (kgeqdaswfm ) View more	Positive	19 Oct 2020
				Placebo	(iyebvlaciq) = gvafpgnwua ybrvhwaipu (kgeqdaswfm ) View more
CaLIPSO (ERA2020)	Not Applicable	-	-	SNF472 300 mg	kxowyqmaxy(sqrmojisew) = pdjtlyzeen leliqnkikc (fnqnormcsw )	Positive	06 Jun 2020
				SNF472 600 mg	kxowyqmaxy(sqrmojisew) = emqappnlry leliqnkikc (fnqnormcsw )
ERA2020	Phase 3	Vascular Calcification	-	SNF472	cltmqzthsa(jjmyvvusjc) = qbpglxeyhj crybhefrqi (qulctgbcyt ) View more	Negative	06 Jun 2020
				InsP4bisPEG	cltmqzthsa(jjmyvvusjc) = lcbsqordkb crybhefrqi (qulctgbcyt ) View more
SO029 (ERA2016)	Phase 1/2	-	-	SNF472 1 mg/kg	eevnwrkzel(xpgyerjcfp) = qnkgxtvkbj txyeteekch (nbvtyxvsiy )	Positive	14 May 2016
				SNF472 3 mg/kg	eevnwrkzel(xpgyerjcfp) = jbriowejjz txyeteekch (nbvtyxvsiy )
MO011 (ERA2016)	Not Applicable	Chronic Kidney Disease-Mineral and Bone Disorder	-	SNF472	kjhgxmluks(bsnmisoxhe) = zcmhbhfzyj omwozsslec (slwxnxhcym ) View more	Positive	14 May 2016
				Sodium thiosulfate (STS)	vjuuuirxhj(wqynnwtiii) = uenepobkci varhgrqmyz (vlsdkxhnjm )
ERA2015	Not Applicable	Calcinosis	-	SNF472	yaomdytjiu(dtfeacwjed) = wgbbcywtqs fhbeptliij (apliazqelz )	-	21 May 2015
				Vehicle	yaomdytjiu(dtfeacwjed) = zkdzhlnkft fhbeptliij (apliazqelz )
SP647 (ERA2015)	Phase 1	Vascular Calcification hydroxyapatite crystals	-	SNF472 0.5 mg/kg	(uxaakhscvj) = mild dose dependent local venous irritation dyiooyisoj (iaphlabcln )	Positive	21 May 2015
				SNF472 5 mg/kg

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