EASL

The Hunt for Virus Treatments Continues Post Covid-19

Retrieved on: 
Freitag, Juni 7, 2024
Patient, AD8, Immunotherapy, Infection, Virology, NIAID, Safety, Monkeypox virus, MERS-related coronavirus, Harvard Medical School, Light, Viral, News, Congress, File, EASL, Disease, MASH, WHO, Zika virus, CHB, Dengue virus, Virus, Cancer, Drug development, Bangladesh Technical Education Board, Poultry, Research, Therapy, Cytomegalovirus, World Health Organization, COVID-19, Government, Animal, Hepatitis B, SHIV, Exosome, Lassa mammarenavirus, West Nile virus, Hook effect, Viremia, Immune system, Human, Eye, HBV, FDA, Chikungunya, HIV, H5N2, ART, Vaccine

Continued: "Scientists are on alert for changes in the virus that could signal that bird flu is adapting to spread more easily among humans.

Key Points: 
  • Continued: "Scientists are on alert for changes in the virus that could signal that bird flu is adapting to spread more easily among humans.
  • With global populations and economies still feeling the impact of Covid-19, any virus threat is going to make headlines.
  • "Additionally, in vitro, the Hemopurifier has been demonstrated to capture Zika virus, Lassa virus, MERS-CoV, cytomegalovirus, Epstein-Barr virus, Herpes simplex virus, Chikungunya virus, Dengue virus, West Nile virus, smallpox-related viruses, H1N1 swine flu virus, H5N1 bird flu virus, Monkeypox virus and the reconstructed Spanish flu virus of 1918.
  • Both these workers experienced symptoms in the eye after coming into contact with dairy cows infected with the H5N1 virus."

HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate...

Retrieved on: 
Montag, Juni 17, 2024
Congress, Abstract, Therapy, Efficacy, EASL, Poster, MASH, DSM-IV codes, T2DM, HKEX, Safety, HighTide, Pharmaceutical industry

HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate...

Key Points: 
  • HighTide Therapeutics Presents Analyses of Phase 2a MASH Study at the 2024 International Liver Congress, Reinforcing and Further Characterizing the Efficacy and Safety of Berberine Ursodeoxcyholate...
  • The presentations include post-hoc analyses of the Phase 2a clinical study of berberine ursodeoxcyholate (HTD1801), a gut-liver anti-inflammatory metabolic modulator, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and comorbid type 2 diabetes mellitus (T2DM) (NCT03656744).
  • The ongoing multi-regional Phase 2b study (CENTRICITY, NCT05623189), now fully enrolled, evaluates the histologic benefit of HTD1801 in this same patient population.
  • “Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM” (Abstract SAT-227, Poster Presented June 8)

Barinthus Bio Announces Strategic Pipeline Prioritization Following Positive Interim Data from VTP-300 in Chronic Hepatitis B Virus Infections

Retrieved on: 
Mittwoch, Juni 12, 2024
Congress, HBsAg, Patient, Prostate cancer, Hepatitis B, EMA, Workforce, EASL, Disease, Coeliac disease, HBV, Probability, FDA, CHB, Barinthus, Vaccine

The development of VTP-300 in chronic Hepatitis B (CHB) and VTP-1000 in celiac disease will be prioritized.

Key Points: 
  • The development of VTP-300 in chronic Hepatitis B (CHB) and VTP-1000 in celiac disease will be prioritized.
  • The pipeline prioritization is expected to result in a reduction in workforce of approximately 25% and an estimated extension to the cash runway into the second quarter of 2026.
  • The decision follows the positive interim data from the two ongoing Phase 2 clinical trials presented at the European Association for the Study of the Liver (EASL) Congress on June 6, 2024.
  • In line with our pipeline prioritization, we have made the difficult decision to reduce our workforce.

Global Multiple Sclerosis Drugs Market Size Projected to Reach $38 Billion By 2032 as Demand on R&D for Developing Innovative Drugs Rises

Retrieved on: 
Dienstag, Juni 11, 2024
European, Patient, Prevalence, ALS, Multiple sclerosis, Sclerosis, Civil service commission, Cure, MND, Pharming, Fast Track, Biogen, News, Congress, Ventilation, Roche, CMSC, Mutation, EASL, Disease, Fibrosis, DMTS, MASH, OTCQX, Food, Partnership, Eli Lilly and Company, MFIS, SMA, NEJM, Central nervous system, TLSA, Therapy, Foralumab, Biomarker, BIIB, Disability, PALM, Government, Diagnosis, Human, Multiple, EDSS, DSM-IV codes, USD, RMS, Liver injury, LLY, European Commission, Brain, Physician, Failure, Multiple Sclerosis International Federation, Inflammation, FDA, Publication, Treatment, Pharmaceutical industry

Tiziana Life Sciences, Ltd. (NASDAQ: TLSA) Requests Fast Track Designation Approval From FDA for Treatment of Multiple Sclerosis -- Tiziana Life Sciences, Ltd. (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted a request for intranasal foralumab to receive Fast Track Designation for the treatment of non- active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • In 2000, it was estimated by the National Multiple Sclerosis Society that around 400,000 Americans had the disease.
  • The number of individuals with multiple sclerosis is rapidly increasing, and with no known cure, the demand for effective treatment has increased immensely.
  • A report from Fortune Business Insights projected that the global multiple sclerosis drugs market size was valued at USD 21.33 billion in 2023 and is projected to grow from USD 21.16 billion in 2024 to USD 38.94 billion by 2032, exhibiting a CAGR of 7.9% during the forecast period (2024-2032).
  • The number of people with multiple sclerosis across the globe increased from 2.3 million in 2013 to 2.8 million in 2020, according to the Multiple Sclerosis International Federation.

Sagimet Biosciences to Host Conference Call and Webcast to Discuss Recently Presented Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat 

Retrieved on: 
Montag, Juni 10, 2024
Congress, Webcast, Patient, Hepatology, FASN, SAN, EASL, Q&A, Principal investigator, MASH, ID, Pharmaceutical industry

Dr. Loomba will discuss positive data from Sagimet’s FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients which he recently presented at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy.

Key Points: 
  • Dr. Loomba will discuss positive data from Sagimet’s FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients which he recently presented at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy.
  • Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH.
  • The live webcast and replay may be accessed by visiting the Sagimet website here .
  • The Call me™ link will be made active 15 minutes prior to scheduled start time.

Helio Genomics’ HelioLiver Dx Test Meets Coprimary and Secondary Study Endpoints in the CLiMB Trial, Presented at the EASL Congress 2024

Retrieved on: 
Montag, Juni 10, 2024
Congress, Division, Climbing, Patient, Hepatology, Cirrhosis, MRI, EASL, Clinical trial, DNA, Methylation, Biomarker, HCC, Nucleic acid thermodynamics, University, AI, Disease, NCI, Hepatocellular carcinoma, Liver cancer, AASLD, Medical imaging

46 participants (3.6%) had HCC, confirmed by MRI:

Key Points: 
  • 46 participants (3.6%) had HCC, confirmed by MRI:
    The HelioLiver Dx test met the prespecified coprimary endpoints – Overall superior sensitivity (> 5%) and non-inferior specificity (> -10%) compared to ultrasound for detecting HCC lesions.
  • The HelioLiver Dx test met the prespecified secondary endpoint – Superior sensitivity compared to ultrasound for detecting HCC lesions ≤ 4 cm in diameter.
  • HelioLiver Dx outperformed ultrasound for sensitivity to detect HCC lesions in cirrhotic patients:
    All HCC lesions: 47.8% for HelioLiver Dx vs. 28.3% for ultrasound
    HCC lesions ≤ 4 cm: 37.8% for HelioLiver Dx vs. 13.5% for ultrasound
    HCC lesions
  • T1 HCC lesions: 44.4% for HelioLiver Dx vs. 11.1% for ultrasound

Surrozen Presents Preliminary Results from Phase 1a Study of SZN-043 in Healthy Volunteers and Patients with a History of Liver Cirrhosis at the 2024 European Association for the Study of the Liver (EASL) in Milan

Retrieved on: 
Montag, Juni 10, 2024
Patient, Hepatocyte, Alkaline phosphatase, Cirrhosis, SAN, EASL, CYP1A2, LINK, Liver disease, Regeneration, Therapy, History, HFR, ALP, Crosstalk (biology), Dicarboxylic acid, Vaccine

SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, presented a poster on the preliminary results of a Phase 1a study of SZN-043, a novel R-Spondin mimetic, in healthy volunteers and subjects with liver cirrhosis on June 8, 2024 at the 2024 European Association for the Study of the Liver (EASL) in Milan (LINK: HERE).  

Key Points: 
  • Safe and well-tolerated doses of SZN-043 were established in the randomized, placebo-controlled, first-in-human, Phase 1a trial in 40 healthy volunteers (HVs) and 8 patients with a history of liver cirrhosis.
  • Single or multiple intravenous infusion doses were administered in a range from 0.5 mg/kg to 3 mg/kg.
  • In some treated subjects, there were mild-to-moderate, transient, and dose-related serum transaminase elevations that resolved without intervention.
  • The study provided evidence of Wnt-mediated pharmacodynamic activity in the liver after treatment with SZN-043.

Akero Therapeutics Presents Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024

Retrieved on: 
Samstag, Juni 8, 2024
Congress, Patient, SAN, Therapy, EASL, Fibrosis, Safety, MASH, EFX, DSM-IV codes, Pharmaceutical industry

At Week 96, response rates for this endpoint increased to 75% (p

Key Points: 
  • At Week 96, response rates for this endpoint increased to 75% (p
  • A poster presentation will present results from a post-hoc analysis of key biomarkers associated with collagen synthesis and degradation.
  • These data improve our understanding of EFX pharmacology and its effects on extracellular matrix (ECM) remodeling in the liver and fibrosis improvement.
  • “We are highly encouraged by these results, which are the first reports of histological improvement after more than 48 weeks.

Zealand Pharma announces that Boehringer Ingelheim’s survodutide demonstrates breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis

Retrieved on: 
Freitag, Juni 7, 2024
Boehringer Ingelheim, EASL, Fibrosis, Risk, MASH, Obesity, F1, F2, Medical imaging

New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH.

Key Points: 
  • New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH.
  • Additional sub-analysis shows up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH.
  • “We are very excited by the impressive Phase 2 trial results announced today by Boehringer Ingelheim for survodutide in MASH”, said David Kendall, MD, Chief Medical Officer of Zealand Pharma.
  • “These Phase 2 data provide evidence of clear differentiation that positions survodutide as a potential incretin-based treatment for both obesity and MASH.

Boehringer Ingelheim’s survodutide shows breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 and F3 fibrosis

Retrieved on: 
Freitag, Juni 7, 2024
Boehringer Ingelheim, EASL, Fibrosis, Risk, MASH, F1, F2, Medical imaging

News builds on previously announced primary endpoint, which showed up to 83.0% of adults achieved statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%).

Key Points: 
  • News builds on previously announced primary endpoint, which showed up to 83.0% of adults achieved statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%).
  • New data on the secondary endpoint shows up to 52.3% of adults with fibrosis stages F1, F2 and F3 had improvement in fibrosis due to MASH.1
    Survodutide to advance into Phase III MASH study; results reinforce its potential as a best-in-class MASH treatment and, with ongoing trials in obesity,2 could lead to clinically meaningful benefits across the cardiovascular, renal, and metabolic spectrum.
  • We will advance quickly into Phase III trials,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim.
  • Zealand has a co-promotion right in the Nordic countries.