Connect with us
Prague Gaming & TECH Summit 2025 (25-26 March)

Fintech PR

Imlifidase met primary endpoint in 16-HMedIdes-12 phase 2 trial in patients with AMR following kidney transplantation

Published

on

imlifidase-met-primary-endpoint-in-16-hmedides-12-phase-2-trial-in-patients-with-amr-following-kidney-transplantation

Statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to standard of care

LUND, Sweden, Dec. 14, 2023 /PRNewswire/ — Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment.

In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment. Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value: <0.001) reduction in patients who received standard of care (plasma exchange, or PE). DSA levels subsequently returned to approximately 70% of the initial level in both treatment arms.

The secondary endpoint investigated overall kidney function following treatment. The imlifidase arm demonstrated a 74% six-month graft survival and eGFR of 30mL/min/1.73m2. A 100% six-month graft survival and eGFR of 33mL/min/1.73m2 was observed in the PE arm. Given the heterogeneity of the patient population, the trial was not designed nor sufficiently powered to be able show a statistically significant difference in the secondary outcome measures. Imlifidase demonstrated a safety profile consistent with previous clinical trials.

Dr. Achim Kaufhold, Chief Medical Officer, Hansa Biopharma said, “This is the first clinical trial with a head-to-head comparison of imlifidase and a frequently used standard of care treatment (plasmapheresis, or plasma exchange). Plasmapheresis can be challenging for both the patient and the physician, often requiring multiple treatment sessions over several weeks with slow reduction in donor specific antibody (DSA) levels. We are very encouraged by these results which underscore imlifidase’s ability to rapidly reduce DSA levels, which is good news for patients who require safe and efficient reduction of DSA levels.”

Prof. Stanley Jordan MD, Principal Investigator, Director of Division of Pediatric and Adult Nephrology at Cedars Sinai Medical Center, Los Angeles said, “AMR is a heterogeneous and complex disease that remains difficult to diagnose and treat. As clinicians we focus on reduction of DSAs levels quickly and effectively to limit the irreversible damage to the organ that can occur. This is an important step in understanding how imlifidase may benefit patients with AMR. The findings of this trial may inform a path forward to potentially address the issues of chronic inflammation and antibody rebound which will allow clinically meaningful results for this very difficult to treat patient population.”

The AMR patient population is heterogeneous, consisting of both chronic patients – those who experience slow rejection after a transplant, and which often results in irreversible damage to the organ – and acute patients who experience AMR early post-transplant. Additionally, AMR can be driven by a combination of antibodies and T-cells-mediated action (CMR – cell mediated rejection), creating additional complexity when it comes to treatment strategy. Treatment guidelines indicate reduction of DSA levels as one of the main goals of any AMR treatment.1 To date, there are no approved therapies for the treatment of AMR, and all current treatments including standard of care are used off-label.1

More information about the trial is available at ClinicalTrials.gov: NCT03897205.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 20:00 CET on 14 December 2023.

Contacts for more information:

Advertisement

Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709 298 269
E: [email protected]

Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802
E: [email protected]

Notes to editors

About imlifidase

Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.2 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

About 16-HMedIdes-12

16-HMedIdes-12 is randomized, open-label, multi-center, controlled phase 2 trial designed to evaluate safety, tolerability, and efficacy of imlifidase compared to plasma exchange (PE) in removal of DSAs in patients experiencing active and chronic active AMR episodes. The trial included 30 patients with AMR randomized to receive either imlifidase or PE in a 2:1 ratio.

About imlifidase and autoimmune diseases

Autoimmune diseases occur when the immune system mistakenly recognizes the body’s own proteins, as foreign and mounts an immune response, creating antibodies against the body’s own cells and tissues. Many autoimmune diseases are driven by pathological IgGs.

Hansa is exploring how imlifidase may be able to prevent or slow disease progression including debilitating, life-threatening symptoms. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease, Guillain-Barré Syndrome, and ANCA-associated vasculitis.

Advertisement

About Hansa Biopharma

Hansa Biopharma is a commercial-stage biopharmaceutical company and pioneer in immunoglobulin G (IgG)-cleaving enzyme technology on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class IgG antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com.

References

1.        Schinstock CA, et al. Transplantation. 2020 May;104(5):911-922.

2.        EDQM. (2020). International figures on donation and Transplantation 2019

The following files are available for download:

https://mb.cision.com/Main/1219/3894073/2496348.pdf     20231214 – HNSA 16-12 AMR trial full data read out – En

View original content:https://www.prnewswire.co.uk/news-releases/imlifidase-met-primary-endpoint-in-16-hmedides-12-phase-2-trial-in-patients-with-amr-following-kidney-transplantation-302016091.html

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Fintech PR

President Emmerson Mnangagwa met this week with Zambia’s former Vice President and Special Envoy Enoch Kavindele to discuss SADC’s candidate for the AfDB

Published

on

president-emmerson-mnangagwa-met-this-week-with-zambia’s-former-vice-president-and-special-envoy-enoch-kavindele-to-discuss-sadc’s-candidate-for-the-afdb

President Mnangagwa, who is SADC Chairperson, reaffirmed his own country’s and SADC’s enthusiastic support for Zambian candidate Sam Maimbo

LUSAKA, Zambia, Dec. 20, 2024 /PRNewswire/ — Special Envoy Kavindele released the following statement following the meeting:

“I am elated to witness the growing success and momentum of Sam Maimbo’s candidacy to become the next President of the African Development Bank. I am filled with gratitude to our friends across both SADC and COMESA for their continued support and good wishes.

Sam has garnered such wide consensus due to his being uniquely qualified to deliver the transformative change and empowerment our continent needs. Sam’s 30 years in development work is defined by driving outcomes, improving processes, and investing in people. The AfDB needs a hands-on leader who is laser focused on delivering results and who is unafraid of making tough decisions in order to best serve our continent. Sam is that leader. Sam has the track record and experience to drastically enhance the pace, scale, and impact of the Bank’s work in service of the people and governments of Africa.

Our region has a proud history of supporting fellow Southern Africans. For example, we all recall Lusaka’s role in hosting the African National Congress’ headquarters during the dark days of Apartheid oppression.

It therefore gives me no pleasure to observe my South African brothers, who have themselves leant on Zambia’s steadfast friendship over many decades, fail to rally behind both SADC and COMESA’s chosen candidate for the AfDB. Africa’s urgent economic development challenges demand transformational leadership at the AfDB, it is all of our responsibility to put forward the best candidate for the job. This is not the time or place for a government to act with narrow self-interest, we all must act in the continent’s and AfDB’s best interest.

I thank Sam Maimbo for his lifelong service to our entire continent, and I am eager to witness his enormous impact as President of the AfDB.”

View original content:https://www.prnewswire.co.uk/news-releases/president-emmerson-mnangagwa-met-this-week-with-zambias-former-vice-president-and-special-envoy-enoch-kavindele-to-discuss-sadcs-candidate-for-the-afdb-302337613.html

Continue Reading

Fintech PR

Stay Cyber Safe This Holiday Season: Heimdal’s Checklist for Business Security

Published

on

stay-cyber-safe-this-holiday-season:-heimdal’s-checklist-for-business-security

LONDON, Dec. 20, 2024 /PRNewswire/ — Heimdal Security shares a practical holiday cybersecurity checklist, offering expert insights to help businesses safeguard against cyber threats this festive season.

With reduced staffing, remote work setups, and a surge in online shopping creating heightened vulnerabilities, this guide offers actionable tips to enhance business security.

Going beyond basic advice, the checklist also highlights the most common holiday scams and features videos showcasing real-life examples of Christmas-themed cyber scams and effective prevention strategies.

Key Tips to Protect Businesses This Holiday Season:

  1. Strengthen endpoints: Ensure devices are updated with antivirus and endpoint protection software; consider Endpoint Detection and Response (EDR) and application whitelisting.
  2. Prepare for phishing spikes: Train staff to identify suspicious emails, enforce robust email filters, and establish protocols for reporting unusual activity.
  3. Secure remote access: Mandate VPN usage, monitor unusual logins, and deactivate inactive accounts temporarily.
  4. Segment and shield networks: Isolate sensitive areas, deploy DNS security and advanced firewalls, and maintain full visibility over network traffic.
  5. Apply timely patches: Regularly update all systems and test patches in a controlled environment to minimize disruptions.
  6. Mitigate supply chain risks: Assess vendors thoroughly and limit their access to essential systems.
  7. Have a response plan ready: Tailor incident protocols for the holidays, create an on-call rotation for the IT team, and enable rapid action against suspicious activity.

Cybercriminals thrive on holiday distractions, but with proactive measures like phishing training, secure endpoints, and network segmentation, businesses can stay ahead of potential threats,” said Alex Panait, System Administrator at Heimdal Security.

Common Holiday Scams That Businesses Should Watch For:

Cybercriminals often tailor their tactics to exploit the festive season. The most common scams include:

  • Spear phishing: Emails disguised as holiday bonuses or event invitations that steal credentials or spread malware.
  • Malicious holiday E-Cards: Festive greetings that contain links deploying ransomware or spyware.
  • Fake E-Commerce sites: Fraudulent websites offering discounts to steal payment information.
  • Insider threats: Distracted or disgruntled employees mishandling or exploiting sensitive data.
  • Corporate travel scams: Fake booking platforms targeting business travelers.
  • Business email compromise (BEC): Fraudulent requests for urgent wire transfers during year-end financial rushes.

For more, read the full article here or watch the video on YouTube to see how these threats unfold and learn actionable prevention strategies.

About Heimdal:
Established in Copenhagen in 2014, Heimdal® empowers CISOs, security teams, and IT administrators to improve their security operations, reduce alert fatigue, and implement proactive measures through a unified command and control platform.

Heimdal’s award-winning cybersecurity solutions span the entire IT estate, addressing challenges from endpoint to network levels, including vulnerability management, privileged access, Zero Trust implementation, and ransomware prevention.

For further press information:

Madalina Popovici
Media Relations Manager
[email protected] 

Advertisement

 

View original content:https://www.prnewswire.co.uk/news-releases/stay-cyber-safe-this-holiday-season-heimdals-checklist-for-business-security-302337465.html

Continue Reading

Fintech PR

According to Tickmill survey, 3 in 10 Britons in economic difficulty: Purchasing power down 41% since 2004

Published

on

according-to-tickmill-survey,-3-in-10-britons-in-economic-difficulty:-purchasing-power-down-41%-since-2004

The people who have the most problems are women (30%) and are between 35 and 49 years old (39%)

ROME, Dec. 20, 2024 /PRNewswire/ — The purchasing power in the UK has dropped by 41% over the last 20 years. Today, £100,000 left in a bank account since 2004 without being invested would now be worth £59,021.

This figure is one of the findings from a study conducted by Tickmill, an international online trading broker that compared the economic situation in the UK and the European Union through the infographic “Purchasing Power and Cost of Living: UK vs EU”.

The analysis reveals a slight decline of 0.4% in the UK’s purchasing power, which currently stands at £41,573. In contrast, the European Union has seen a modest rise of 0.1%, reaching £40,874.

Why is purchasing power declining in the UK? One key factor is the cost of living. If the UK were still part of the European Union, it would rank as the fifth most expensive country, behind Ireland, Luxembourg, Denmark, and the Netherlands.

Unsurprisingly, 3 in 10 Britons are struggling with the cost of living. Women (3 in 10, compared to 25% of men), those aged between 35 and 49 (4 in 10), households earning less than £15,000 (6 in 10), and single parents (1 in 2) are among the most affected groups.

Among UK nations, Northern Ireland is the hardest hit, with 34% of its population facing financial difficulties, followed by Wales (31%), England (28%), and Scotland (22%). In England, the North East has the highest percentage of people struggling, with 4 in 10 residents affected. Even in London, the high costs impact 1 in 4 adults.

Advertisement

In response to these challenges, Britons are making significant adjustments:

  • 53% have cut back or delayed spending on smaller items like eating out, entertainment, subscriptions, clothing, toys, books, etc.;
  • 52% have reduced household energy consumption;
  • 48% have decreased their grocery spending;
  • 41% have scaled back or postponed major expenditures, such as holidays, cars, and weddings;
  • 26% are working longer hours, taking on overtime, or pursuing additional jobs to earn extra income.

The British also made changes on the financial side. One in four adults has been forced to dip into their savings or investments to cover daily expenses. Moreover, 44% have stopped saving or investing entirely or have reduced their savings and investments—a 4% increase compared to 2023.

The lack of investment is another critical factor contributing to the decline in purchasing power. It is estimated that 13 million UK residents hold £430 billion in cash deposits but do not invest. The reasons? Seventy-four percent say they cannot compare investment products effectively, and 43% are afraid of losing their money.

A lack of knowledge and fear are preventing many savers from taking advantage of an important opportunity: preserving or increasing their purchasing power in the long term.

Photo: https://mma.prnewswire.com/media/2586123/Tickmill.jpg
Logo: https://mma.prnewswire.com/media/2586129/Tickmill_Logo.jpg

Cision View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/according-to-tickmill-survey-3-in-10-britons-in-economic-difficulty-purchasing-power-down-41-since-2004-302337354.html

Continue Reading

Trending