Connect with us
European Gaming Congress 2024

Artificial Intelligence

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Published

on

calliditas-therapeutics-to-present-seven-abstracts-at-the-american-society-of-nephrology-(asn)-kidney-week-2023

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ — Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) (“Calliditas”), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Investigators will be presenting additional analyses of the Phase 3 NefIgArd study’s 2-year data with Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) for the treatment of Primary IgA nephropathy (IgAN). Presentations will highlight the statistically significant and clinically meaningful treatment benefit of Nefecon, including an oral presentation on the preservation of eGFR in patients with IgAN treated with Nefecon, as well as the Company’s late-breaking poster presentation that will showcase the long-term renal benefit with Nefecon in Chinese patients with primary IgAN. Additionally, pre-clinical data on the treatment of Alport syndrome with setanaxib will be presented following the Company’s recent orphan drug designations granted in the US and receiving a favourable opinion regarding orphan drug classification in Europe.
“We take great pride in the robust clinical evidence we have gathered and look forward to presenting additional findings at ASN from our Phase 3 NefIgArd trial that further establish the beneficial effect of Nefecon on eGFR,” said Richard Philipson, Chief Medical Officer at Calliditas. “These analyses, in addition to a presentation highlighting our new clinical program in the renal space targeting Alport syndrome, reinforce our dedication to expanding treatment options and establishing novel standards of care in rare kidney diseases.”
Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas’ corporate website following the meeting. 
Oral Presentation Details:
Title: eGFR decline in patients with IgAN treated with Nefecon or placebo: Results from the 2-year NefIgArd Phase 3 trialPresenter: Richard Lafayette, M.D., F.A.C.P., Stanford HealthcareDate and Time: Thursday, November 2, 5:15 p.m. – 5:24 p.m. ETSession: Glomerular Diseases: Clinical and Translational Studies [OR1402]Presentation No.: TH-OR26 (Abstract 3938831)Presentation Venue: Room 103 (Pennsylvania Convention Center)
Late-Breaking Poster Presentation Details:
Title: Long-term renal benefit with Nefecon in Chinese patients with primary immunoglobulin A nephropathy: 2-year NefIgArd trial resultsPresenter: Hong ZhangDate and Time: Thursday, November 2, 10:00 a.m. – 12:00 p.m. ETSession: Late-Breaking Posters [LB-PO] Presentation No.: TH-PO1123 (Abstract 3969868)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Poster Presentation Details:
Title: The NOX inhibitor setanaxib combined with ramipril reduces glomerular function decline and fibrosis in a mouse model of Alport syndromePresenter: Thierry ChristopheDate and Time: Thursday, November 2, 10:00 a.m. – 12:00 p.m. ETSession: Genetic Diseases: Glomerulopathies – I [PO1202-1]Presentation No.: TH-PO481 (Abstract 3940209)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Analysis of the NefIgArd Part A study confirms Nefecon modulated proteins involved in the intestinal immune network for IgA productionPresenter: Roisin ThomasDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO893 (Abstract 3941804)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Analysis of the NefIgArd Part A study population confirms Nefecon reduces levels of dietary antigen-specific IgA in patients with IgA nephropathyPresenter: Victoria CottonDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO892 (Abstract 3941892)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Modeling based on NefIgArd 2-year eGFR total slope predicts long-term clinical benefit of Nefecon in a real-world IgAN populationPresenter: Jonathan Barratt, M.B.Ch.B., Ph.D., University of LeicesterDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO886 (Abstract 3943328)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: TRF-budesonide (Nefecon) reduces serum biomarkers of lymphocyte activation in IgA nephropathy, which correlate with changes in serum BAFF levelsPresenter: Nadia Nawaz, University of LeicesterDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO890 (Abstract 3941858)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
For more information, visit the American Society of Nephrology (ASN) website here.
Indication
TARPEYO® (budesonide) delayed release capsules is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.
Important Safety Information
Contraindications: TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.
Warnings and Precautions
Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy [see Dosing and Administration] or switching between corticosteroids, monitor for signs of adrenal axis suppression.
Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).
Risks of immunosuppression: Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections; or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (eg., chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.
Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, a family history of diabetes or glaucoma, or with any other condition in which corticosteroids may have unwanted effects.
Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO patients and ≥2% higher than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase (7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).
Drug interactions: Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.
Use in specific populations
Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.
Please see Full Prescribing Information.
About TARPEYO1
Calliditas has introduced TARPEYO, the first FDA-approved therapy for the treatment of the autoimmune renal disease primary IgA Nephropathy, or IgAN, to reduce proteinuria in adults with primary IgAN who are at risk of rapid disease progression, generally a UPCR≥1.5g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
TARPEYO is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. TARPEYO is as a 4 mg delayed release capsule and is enteric coated and designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. It is unclear to what extent TARPEYO’s efficacy is mediated via local effects in the ileum vs systemic effects.
About the NeflgArd Study
The global clinical trial NefIgArd is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN (N=364), as an addition to optimized RAS inhibitor therapy. Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B included a 12-month observational period off drug and assessed eGFR over the entire 2-year period for patients who were treated with the TARPEYO or placebo regimen in Part A. The full NefIgArd trial met its primary endpoint. Topline data from the full NefIgArd study were reported on March 12, 2023.
About Primary Immunoglobulin A Nephropathy
Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney.2,3 This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s.3,4
Footnotes:
1 TARPEYO® (budesonide) [prescribing information]. Stockholm, SE: Calliditas Therapeutics AB; 20212 Barratt, J., & Feehally, J. (2005). IgA nephropathy. J Am Soc Nephrol, 16(7), 2088-2097. https://doi.org/10.1681/ASN.20050201343 Barratt, J., Rovin, B. H., Cattran, D., et al. (2020). Why Target the Gut to Treat IgA Nephropathy? Kidney Int Rep, 5(10), 1620-1624. https://doi.org/10.1016/j.ekir.2020.08.0094 Jarrick, S., Lundberg, S., Welander, A., et al. (2019). Mortality in IgA Nephropathy: A Nationwide Population-Based Cohort Study. J Am Soc Nephrol, 30(5), 866-876. https://doi.org/10.1681/ASN.2018101017 
For further information, please contact:
Åsa Hillsten, Head of IR, CalliditasTel.: +46 76 403 35 43, E-Mail: [email protected]
The information was sent for publication, through the agency of the contact persons set out above, on October 19 at 8.00 a.m. CET.
The following files are available for download:
https://mb.cision.com/Main/16574/3856502/2369380.pdf
Calliditas ASN ENG
 

View original content:https://www.prnewswire.co.uk/news-releases/calliditas-therapeutics-to-present-seven-abstracts-at-the-american-society-of-nephrology-asn-kidney-week-2023-301961767.html

Continue Reading
Advertisement
Stake.com

Artificial Intelligence

ZA Tech Rebrands as Peak3, Raises US$35M Series A led by EQT

Published

on

za-tech-rebrands-as-peak3,-raises-us$35m-series-a-led-by-eqt

SINGAPORE, June 19, 2024 /PRNewswire/ — ZA Tech, the next-generation insurance core system SaaS provider, has rebranded as Peak3. With the successful completion of its US$35 million Series A fundraising from EQT (lead investor) and Alpha JWC Ventures, Peak3 now accelerates its expansion in the EMEA region and investments in complementary data and AI solutions.

In a market dominated by fragmented legacy technology, Peak3 has pioneered a cloud-native, modular insurance core and distribution system that combines comprehensive capabilities for life, health, and property and casualty (P&C) insurance. Since its founding in 2018, Peak3 has become a trusted technology partner to global insurers such as AIA, Generali, Prudential, and Zurich for their digital and traditional business. It has also partnered with leading digital platforms such as Carro, Grab, Klook, and PayPay to build and scale their embedded insurance businesses.
Besides the successful fundraising, Peak3 has recently achieved key milestones underpinning the rebranding. These transformative achievements include launching its first multi-country, multi-tenant core modernisation in Europe, rolling out an integrated customer data and big data platform for scaling analytics and AI capabilities, and establishing its first technology centre in Europe. The rebranding coincides with another major milestone: Issuing over a billion insurance policies on Peak3’s systems – including the first policies issued to North American customers and the first ones to be issued in Africa.
“We have evolved from an embedded insurance pioneer in Asia to a global end-to-end technology partner for the insurance industry,” said Bill Song, Peak3 Group CEO and Co-Founder. “Our new name represents three pinnacles: scaling the heights of innovation, surpassing performance limits, and delivering superior reliability – as we help insurers reach the highest summits of their cloud, data, and AI transformation.”
Bill Song also emphasised the growth opportunity: “There is an incredible tech investment backlog in the US$7-trillion global insurance industry. Continued digitalisation and the proliferation of AI will require structural investments by insurers over the next decade to modernise their core systems. We are uniquely positioned to capture this opportunity by providing the tech core foundations and innovation use cases.” 
To accelerate its growth journey, Peak3 completed its Series A fundraising and welcomed two new investors on its cap table: EQT, a major global technology investor with a deep heritage in Europe, and Alpha JWC Ventures, a leading venture firm in Southeast Asia. With the funding, Peak3 will advance its analytics and AI capabilities toward an intelligent core insurance solution, grow its EMEA operations and establish new system integrator partnerships. Peak3 targets double-digit ARR growth this year and is on the path to reach cashflow breakeven over the coming quarters.
“Peak3 has also proven its capability to deliver greenfield digital insurance initiatives and complex multi-country core modernisation projects in APAC and EMEA. As the lead investor, EQT is committed to empowering Peak3 in its go-to-market acceleration by leveraging our global network,” stated Clara Ho, Partner at EQT.
J.P. Morgan acted as exclusive financial advisor to Peak3 for this Series A fundraising.
For media inquiries and interview requests, please contact Carling Sia, Global Head of Branding and Marketing, at [email protected].
For more information on Peak3, please visit www.peak3.com. For more information on EQT, please visit www.eqtgroup.com.For more information on Alpha JWC Ventures, please visit www.alphajwc.com.
Photo – https://mma.prnewswire.com/media/2439599/Peak3_PR_Announcement_Photo__002.jpg

View original content:https://www.prnewswire.co.uk/news-releases/za-tech-rebrands-as-peak3-raises-us35m-series-a-led-by-eqt-302175431.html

Continue Reading

Artificial Intelligence

Lucinity Recognized as One of the Top 100 AI Fintech Companies Globally

Published

on

lucinity-recognized-as-one-of-the-top-100-ai-fintech-companies-globally

REYKJAVIK, Iceland, June 18, 2024 /PRNewswire/ — Lucinity has been featured in the AIFinTech100 list for 2024, marking its recognition as one of the top AI companies in the financial services industry. The AIFinTech100 list, curated by industry experts, highlights the most innovative fintech companies globally. Lucinity was selected from over 2,000 fintech firms for its problem-solving, market potential, innovation, and customer engagement. Earlier this year, Lucinity was also highlighted as a RegTech100 company.

 
 
This recognition comes amid rapid AI adoption in fintech. According to Fintech Global, research predicts the AI market in fintech will grow from $42.83 billion to $44.08 billion by 2024, reaching $50.87 billion by 2029. Banks alone are expected to spend $4.9 billion on AI platforms by 2024, with a 21.8% annual growth rate since 2019.
Lucinity’s inclusion in the AIFinTech100 list reflects its success in developing AI solutions that enhance efficiencies and cost savings for financial crime operations teams. Notably, Luci, the world’s first Generative AI copilot for financial crime investigations, launched in 2023, leverages Microsoft OpenAI technologies to augment human analysts’ capabilities, reducing investigation times from 3 hours to just 30 minutes. 
Lucinity also recently launched Luci as a copilot plugin at Money20/20. Financial institutions are now able to integrate Luci with any web-based enterprise application including CRM systems, Case Manager systems, and Excel, delivering immediate ROI with zero upfront integration. 
Security remains a significant challenge in AI adoption. Lucinity addresses this by partnering with Microsoft Azure develop a secure infrastructure. With a strong emphasis on compliance, Luci offers comprehensive auditability through its detailed Audit Log functionality.
Guðmundur Kristjánsson (GK), CEO of Lucinity, comments, “Being named in the AIFinTech100 showcases our impact amongst banks and fintech through advanced AI. It underscores our platform’s ability to empower compliance teams, deliver ROI, and reduce operational costs.”
Richard Sachar, Director of FinTech Global, added, “AI is revolutionizing financial services, increasing efficiencies and offering personalized products. This year’s AIFinTech100 list includes top innovators transforming the industry with AI applications.”
Lucinity’s inclusion in the AIFinTech100 list for 2024 follows several achievements, including winning the Microsoft Partner of the Year Awards for Sustainability and Social Impact and Partner of the Year – Iceland. Lucinity was also included in Chartis Research’s FinCrime and Compliance 50 Ranking for 2024 and was recognized as the best tool for Workflow Automation.
Name: Celina PabloEmail: [email protected] +354 792 4321
Logo – https://mma.prnewswire.com/media/2208676/4770157/Lucinity_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/lucinity-recognized-as-one-of-the-top-100-ai-fintech-companies-globally-302176061.html

Continue Reading

Artificial Intelligence

CRISIL wins Model Validation Tools and Accelerators category award, other recognitions from Chartis

Published

on

crisil-wins-model-validation-tools-and-accelerators-category-award,-other-recognitions-from-chartis

Recognized among top 50 financial services firms for analytics and risk tech
MUMBAI, India, June 18, 2024 /PRNewswire/ — CRISIL, a global provider of advanced analytics and risk management solutions, has won the Solution Category award for Model Validation Tools and Accelerators as part of the latest Chartis STORM 2024 report.

Published by Chartis Research, the leading provider of research and analysis on the global market for risk technology, STORM 2024 is an annual report on quantitative technologies and the computational infrastructure supporting it.
Following an extensive evaluation process, which included a risk technology survey, product demo, customer reference checks, and third-party sources of information, CRISIL won the following recognitions:
Solution category award for Model Validation Tools and AcceleratorsRanked Top 25 (#24) in QuantTech50 2024 rankingsRanked Top 25 (#24) in BuySideRisk50 2024 rankingsRanked Top 50 (#38) in RetailFinanceAnalytics50 2024 rankingsThe recognitions reflect the unparalleled value CRISIL brings to its clients through deep domain expertise, specialized analytical and technical knowledge and our global perspective.
Says Jan Larsen, President and Head, CRISIL Global Research & Risk Solutions, “CRISIL is honored by the recognition across multiple STORM50 award categories this year, including being named first place for Model Validation Tools and Accelerators. This is a great testament to the contributions of our team in giving clients and their regulators confidence in the models they use for making critical decisions.”
The core tenets of CRISIL’s value proposition include expertise across asset classes and risk stripes, analytical excellence and regulatory experience, tailored solutions focused on client delight, continuous improvement and technological innovation. 
Says Ashish Vora, President, CRISIL Market Intelligence and Analytics, “This prestigious recognition underscores the global acceptance of our risk management solutions and highlights our unwavering commitment to excellence in the risk technology space. Our Credit+ technology solutions have been instrumental in offering AI-enabled advanced analytics and driving efficiency, and we are particularly proud of the exceptional client feedback we have received for these solutions. We are constantly exploring new ways to enhance customer value and are investing in cutting-edge technology and domain expertise to maintain our position at the forefront of the industry.”
Notable examples of CRISIL’s platforms that help demonstrate this value proposition include: 
Model Infinity: A leading platform for model inventory management and model risk management. This innovative platform empowers our client to centralize all model activities, eliminates manual processes and operational risk, and provides a full audit trail of approvals for modeling assumptions and updates. Scenario Expansion Manager (SEM): A platform for clients to expand, analyze and track all regulatory and internal scenarios used for stress testing. As a centralized repository of scenarios, SEM allows institutions to eliminate redundant internal work and even provide clients the ability to share internal scenarios with one another. Credit+ ICON: The platform enables credit decision-making through its extensive financial spreading and front-end based credit risk scorecard hosting capabilities. Powered by deep domain expertise, AI-driven analytics and extensive configurability, it serves 40+ global clients across 15 countries.Credit+ Early Warning Signals: The AI-powered solution provides banks with actionable insights to monitor their credit quality, lower loan-loss contingencies and track corrective action plan.About CRISIL Market Intelligence & Analytics
About Global Research & Risk Solutions
About CRISIL Limited
Connect with us: LINKEDIN | TWITTER | YOUTUBE | FACEBOOK 
CRISIL PRIVACY
Disclaimer
This press release is transmitted to you for the sole purpose of dissemination through your newspaper/ magazine/ agency. The press release may be used by you in full or in part without changing the meaning or context thereof but with due credit to CRISIL. However, CRISIL alone has the sole right of distribution of its press releases for consideration or otherwise through any media including websites, portals, etc.
CRISIL has taken due care and caution in preparing this press release. Information has been obtained by CRISIL from sources which it considers reliable. However, CRISIL does not guarantee the accuracy, adequacy or completeness of information on which this press release is based and is not responsible for any errors or omissions or for the results obtained from the use of this press release. CRISIL, especially states that it has no financial liability whatsoever to the subscribers/ users/ transmitters/ distributors of this press release.
Logo – https://mma.prnewswire.com/media/2211784/4276223/CRISIL_logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/crisil-wins-model-validation-tools-and-accelerators-category-award-other-recognitions-from-chartis-302175882.html

Continue Reading

Trending