TNF

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

ACTG Presents Study at CROI Elucidating Mechanism of CMV on Aging-Related Pathways in HIV

Retrieved on: 
Monday, March 4, 2024

CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.

Key Points: 
  • CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV.
  • Prior to the availability of effective antiretroviral therapy (ART) for HIV, CMV caused life-threatening infections in the eyes, brain, and gut in people with compromised immune systems due to advanced HIV.
  • “Investigators have found associations between CMV and heart disease, cancer, and other aging-related complications among people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles.
  • ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair).

Charting New Paths: Non-TNF's Evolving in Rheumatoid Arthritis Market

Retrieved on: 
Friday, February 23, 2024

As demand for improved outcomes rises, it is vital for manufacturers to understand the top drivers catalyzing switching decisions in the well-established, yet continually evolving, RA landscape.

Key Points: 
  • As demand for improved outcomes rises, it is vital for manufacturers to understand the top drivers catalyzing switching decisions in the well-established, yet continually evolving, RA landscape.
  • Ongoing research from Spherix Global Insight’s Patient Chart Dynamix™: Rheumatoid Arthritis (US) service, marking its eighth year of tracking the US RA switch market, sheds light on these key treatment trends and leading opportunities for drug manufacturers.
  • While “TNF cycling” remains common, accounting for about one-third of all switches, this trend has been declining since 2017.
  • Brands that excel in these areas are well-positioned to capture market share and reshape treatment approaches.

United States HUMIRA Market Analysis, Size, Forecast, and Insights Report, 2019-2023 and 2024-2032 - ResearchAndMarkets.com

Retrieved on: 
Friday, March 1, 2024

The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US HUMIRA Market Size, Forecast, and Market Insight - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about HUMIRA for autoimmune uveitis in the US.
  • Further, it also consists of future market assessments inclusive of the HUMIRA market forecast analysis for autoimmune uveitis in the US, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in autoimmune uveitis.
  • What are the other emerging products available and how are these giving competition to HUMIRA for autoimmune uveitis?

Organon Announces HADLIMA™ (adalimumab-bwwd) Has Been Exclusively Selected by the US Department of Veterans Affairs (VA), Replacing HUMIRA on Its National Formulary

Retrieved on: 
Tuesday, February 20, 2024

Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a dedicated commitment to biosimilars, announced that the US Department of Veterans Affairs (VA) has exclusively selected HADLIMA in replacement of HUMIRA (adalimumab) for the VA National Formulary.
  • "America’s veterans deserve access to quality medicines at a lower cost.
  • “We applaud the VA for its leadership in championing biosimilars and including all three of Organon’s biosimilars available in the US on its formulary."
  • HADLIMA was launched in the US to offer patients a more affordable option without compromising on safety and efficacy.

Teva Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

Retrieved on: 
Tuesday, February 20, 2024

“These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.

Key Points: 
  • “These results from the first-in-human trials of anti-TL1A (TEV-’574) are exciting because they show that it effectively engages with the TL1A target, supports its safety profile and is well-tolerated.
  • “We are currently investigating the efficacy and safety of anti-TL1A (TEV-’574) in IBD through the RELIEVE UCCD Phase 2 trial, which features an innovative and efficient basket study design allowing the inclusion of patients with either type of IBD (ulcerative colitis and Crohn’s disease).
  • Each company will equally share the development costs globally and net profits and losses in major markets, with other markets subject to a royalty arrangement, and Sanofi will lead the development of the Phase 3 program.
  • Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world.

EnLiSense CCM Advances Validation of Real-Time IBD Inflammatory Biomarker Monitoring with Two Recent Peer-Reviewed Longitudinal Studies

Retrieved on: 
Thursday, February 15, 2024

Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.

Key Points: 
  • Our innovative IBD Aware device offers the first solution for continuous, non-invasive monitoring of IBD through the power of sweat-sensing technology.
  • EnLiSense's journey reaches a significant milestone with over half a million human biomarker readings, underscoring the extensive validation of our technology.
  • These readings provide crucial data points, enhancing the precision and trustworthiness of inflammatory biomarker monitoring.
  • The studies involved measuring inflammation markers CRP, TNF-α, and IL-6 in subjects' blood and sweat continuously in subjects with and without IBD.

INmune Bio to Participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference

Retrieved on: 
Monday, February 12, 2024

Boca Raton, Florida, Feb. 12, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announced today that RJ Tesi, M.D., Chief Executive Officer, and David Moss, Chief Financial Officer, will present a corporate update at the Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually from February 13-14, 2024.

Key Points: 
  • Boca Raton, Florida, Feb. 12, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announced today that RJ Tesi, M.D., Chief Executive Officer, and David Moss, Chief Financial Officer, will present a corporate update at the Oppenheimer 34th Annual Healthcare Life Sciences Conference being held virtually from February 13-14, 2024.
  • Dr. Tesi and Mr. Moss will be available for one-on-one meetings throughout the conference.
  • Please contact your Oppenheimer salesperson to schedule one-on-one meetings with the management team.

INmune Bio to Participate in Baird’s Biotech Discovery Series Webcast on February 13, 2024

Retrieved on: 
Tuesday, February 6, 2024

Boca Raton, Florida, Feb. 06, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announces its management will be participating in Baird’s Biotech Discovery Series webcast on Tuesday, February 13, 2024 at 10:30AM EST.

Key Points: 
  • Boca Raton, Florida, Feb. 06, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, announces its management will be participating in Baird’s Biotech Discovery Series webcast on Tuesday, February 13, 2024 at 10:30AM EST.
  • The speakers will cover two key topics – first, they will provide an update on the unique features of the Company’s  ongoing blinded, randomized, placebo-controlled Phase II trial for Early Alzheimer's disease (MCI/Mild AD).
  • Baird’s Biotech Discovery Series, which launched in early 2022, is an opportunity for investors to hear directly from interesting and innovative public and private biotech companies in a fireside chat format.
  • We invite key members of management and frequently ask related third parties to join the discussion to learn why they are excited about the science and opportunity for these emerging biotech leaders.

INmune Bio Announces FDA Removal of Clinical Hold for Alzheimer’s Disease Program

Retrieved on: 
Tuesday, January 30, 2024

BOCA RATON, Florida, Jan. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB)  (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted. The Phase II trial is on track to enroll the last patient mid-2024. Top line data is expected approximately six months after the last patient is enrolled.

Key Points: 
  • The Phase II clinical trial in patients with Alzheimer’s disease with neuroinflammation is on track to complete enrollment mid-2024 with top line data expected approximately six months after the final patient is enrolled.
  • BOCA RATON, Florida, Jan. 30, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB)  (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) with XProTM (XPro1595; pegipanermin), a dominant-negative inhibitor of soluble TNF, received correspondence from the FDA confirming that the full clinical hold on the Company’s AD clinical trial program has been lifted.
  • The Phase II trial is on track to enroll the last patient mid-2024.
  • “We are pleased with the FDA’s response and will continue to work closely with the agency in anticipation of our Phase III AD program,” said RJ Tesi, CEO of INmune Bio.