Alcoholic hepatitis

PRODIGY BIOTECH ENTERS INTO A PARTNERSHIP AGREEMENT WITH LEADING CANCER CENTER TO ADVANCE PRODUCTS TO IMPROVE OUTCOMES IN PATIENTS UNDERGOING ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Retrieved on: 
Tuesday, February 6, 2024
MSK, Partnership, Mortality, Alcoholic hepatitis, Research, MD, Therapy, Disease, Patient, IND, Graft-versus-host disease, Alcoholic liver disease, Immunoglobulin Y, Assistant, Drug development, Doctor of Philosophy, SAB, Dysbiosis, Gastrointestinal tract, Bloodstream infections, Cancer, Pharmaceutical industry

The accelerator program launch was announced at the MSK Life Sciences Innovation Summit in New York City on January 26, 2024.

Key Points: 
  • The accelerator program launch was announced at the MSK Life Sciences Innovation Summit in New York City on January 26, 2024.
  • Prodigy and Memorial Sloan Kettering Cancer Center (MSK) will co-develop a product targeting Enterococcus sp.
  • to treat microbial dysbiosis in patients undergoing allogenic hematopoietic stem cell transplantation.
  • February 6, 2024 – Prodigy and MSK have entered into a sponsored research agreement through the MSK Therapeutics Accelerator program to evaluate Prodigy’s product candidate for the improvement of outcomes in patients undergoing allogenic hematopoietic stem cell transplantation (allo-HCT).

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

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Monday, January 22, 2024
Hypoxia, Patient, Alcoholic hepatitis, Cirrhosis, ACLF, Respiratory failure, Society, Risk, Critical care, Mallinckrodt, Oxygen saturation (medicine), Congress, Boxed warning, Critical Care Medicine (journal), Clinical trial, Volume overload, HRS, SCCM, Use, SCR, Dietary supplement

DUBLIN, Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases

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Thursday, January 4, 2024
FDA, Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Alcoholism, Atopic dermatitis, Cholesterol, Metabolism, Multimedia, IND, Alcoholic hepatitis, Disease, Mortality, AMD, Body surface area, Therapy, MELD, Clinical trial, Hospital, Telecanthus, DSM-IV codes, Spasticity, Protocol, Cirrhosis, Biomarker, Triglyceride, Syndrome, Ethanol, Patient, Safety, RASP, Retina, Pharmaceutical industry

ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.

Key Points: 
  • ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.
  • Highlighting the advancement of the RASP platform and the selection of key clinical indications for future development, Aldeyra released a focused pipeline.
  • “With the success achieved in our ADX-629 program, which includes a number of positive, signal-finding clinical results, we are excited to advance our RASP modulator pipeline to systemic and retinal immune-mediated diseases, as well as metabolic diseases, exacerbated by RASP,” stated Dr. Brady.
  • “We anticipate 2024 to provide a variety of clinical-stage catalysts, as Aldeyra continues to progress its novel RASP platform.”

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Retrieved on: 
Wednesday, November 1, 2023
Patient, Comorbidity, Incidence, Respiratory failure, Alcoholic hepatitis, Oxygen saturation (medicine), Boxed warning, Use, Renal replacement therapy, Blood, Health, Kidney, ACLF, Society, American Society of Nephrology, Hepatorenal syndrome, Phase, ASN, Risk, Volume overload, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Mallinckrodt, MD

DUBLIN, Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023.

Key Points: 
  • "1
    These studies are sponsored by Mallinckrodt Pharmaceuticals and include:
    TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

GRI Bio Announces Publication of Comprehensive Invariant NKT (iNKT) Cell Review in Frontiers in Immunology Demonstrating a Key Role of Type 1 iNKT Cells in Modulating Various Fibrotic Conditions

Retrieved on: 
Thursday, October 5, 2023
Consultant, Injury, HIV disease progression rates, Frontiers, Biomarker, NKT, Doctor of Philosophy, Osteopontin, Natural killer T cell, School, Inflammation, Manuscript, IPF, Alcoholic hepatitis, Saint Vincent, Disease, NASH, GRI, Fibroblast, Teaching hospital, IL-6, Idiopathic pulmonary fibrosis, Rheumatoid arthritis, Movement, Liver function tests, St. Vincent's University Hospital, Oxygen, LA, Lupus nephritis, Lupus, Medical school, Associate, Multiple sclerosis, University College Dublin, Fibrosis, Tissue, NK, Macrophage, Human, Cytokine, Chemokine, Patient, Neutrophil, Vaccine, Pharmaceutical industry, Medicine

LA JOLLA, CA, Oct. 05, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the publication of an article that reviews data in both experimental models and in humans that suggest a key role of type 1 invariant NKT (iNKT) cell activation in the progression of inflammatory cascades leading to recruitment of neutrophils and activation of the inflammasome, macrophages, fibroblasts, and, ultimately, fibrosis. The manuscript titled, “Type 1 invariant natural killer T cells in chronic inflammation and tissue fibrosis,” has been published in Frontiers in Immunology.1

Key Points: 
  • iNKT are pro-inflammatory effector T cells that accumulate in many models of chronic fibrotic diseases such as idiopathic pulmonary fibrosis (IPF), lupus nephritis and NASH.
  • I am encouraged by the emerging experimental evidence that iNKT cells play an important role in chronic inflammation and fibrosis.
  • iNKT cells are involved in the regulation of all three, type 1, type 2 and type 3 cytokine associated fibrotic pathways.
  • GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human type 1, iNKT cells.

Incorporating the Patient's Voice in NASH Clinical Trials, Upcoming Webinar Hosted by Xtalks

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Tuesday, October 3, 2023
PPD, KOL, Obesity, NASH, Baylor College of Medicine, Head, Baylor University, Human, Thermo Fisher Scientific, DSM-IV codes, Hepatology, Patient, Surgery, Fatty liver disease, Alcoholic hepatitis, Disease, Pharmaceutical industry, Medicine

TORONTO, Oct. 3, 2023 /PRNewswire-PRWeb/ -- There is immense interest in finding new therapies for non-alcoholic steatohepatitis (NASH), which is increasingly being known as metabolic-associated steatohepatitis (MASH), due to the unmet need and race to the market to get the first treatment approved. In parallel, the rates of MASH are increasing, and it is linked to the global obesity epidemic and related metabolic disorders. MASH is now expected to be the leading indication for liver transplant in the next few years, surpassing hepatitis C and Alcoholic Hepatitis. Despite the high rates of MASH, recruitment to clinical trials remains challenging in NASH clinical trials.

Key Points: 
  • Attendees will learn how to partner across the industry to improve the patient experience by using patient-centric trial strategies in NASH clinical trials.
  • The featured speakers will discuss the strategies to include the patient voice to aid in NASH patient recruitment and retention for clinical trials.
  • Despite the high rates of MASH, recruitment to clinical trials remains challenging in NASH clinical trials.
  • The panel will also discuss the way forward for building on the voice of patients to define strategies to improve patient recruitment and retention in NASH clinical trials.

ZyVersa Therapeutics Reports Second Quarter 2023 Corporate and Financial Results

Retrieved on: 
Monday, August 21, 2023
University of Massachusetts, Marketing, Clinical trial, Neil, Research, Moyamoya disease, CNS, Inflammasome, Government, Juvenile idiopathic arthritis, Professor, Alcoholic hepatitis, Investigational New Drug, Patient, Division, Lupus nephritis, Immunology, DKD, Diabetic nephropathy, Therapy, Infection, Inflammation, Pharmaceutical industry, Vaccine, Cryptocurrency

WESTON, Fla., Aug. 21, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq-GM: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, today provides a corporate update and reports financial results for the second quarter of 2023 ending June 30, 2023.

Key Points: 
  • “The second quarter of 2023 was a period of continued progress at ZyVersa as we completed key corporate, developmental, regulatory and financial initiatives designed to position the company to achieve value-building milestones involving our Cholesterol Efflux Mediator™ VAR 200 and Inflammasome ASC Inhibitor IC 100,” said Stephen C. Glover, Co-founder, Chairman, Chief Executive Officer, and President of ZyVersa.
  • “We are pleased to report our VAR 200 program is progressing as planned, and we anticipate initiation of a Phase 2a clinical trial in diabetic kidney disease (DKD) in the first quarter of 2024.
  • The increase is primarily attributable to an increase of $0.5 million in the costs of manufacturing of IC 100.
  • The impairment is a result of the decline in ZyVersa’s market capitalization as of June 30, 2023.

ZyVersa Therapeutics Reports First Quarter 2023 Corporate and Financial Results

Retrieved on: 
Friday, May 12, 2023
Inflammation, ASC, Hepatitis, University, University of Massachusetts, Marketing, Drug discovery, PIPE, Neil, Infection, CNS, Kidney, Inflammasome, Government, Professor, Alcoholic hepatitis, VAR, HIV disease progression rates, Patient, University of Toronto, Division, Traumatic brain injury, Growth, Immunology, Research, UCLA, Therapy, Cholesterol, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, David Geffen School of Medicine at UCLA, Vaccine, Pharmaceutical industry, Cryptocurrency, Medicine

WESTON, Fla., May 12, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, provides a corporate update and reports financial results for the first quarter of 2023 ending March 31, 2023.

Key Points: 
  • “To that end, we welcomed three new members to our Renal Disease Scientific Advisory Board.
  • ZyVersa will need additional financing to support its continuing operations.
  • ZyVersa will seek to fund its operations through public or private equity or debt financings or other sources, which may include government grants and collaborations with third parties.
  • Net losses for the three months ended March 31, 2023 benefited from a $1.0 Million deferred tax benefit compared to none for the year earlier period.

Mallinckrodt Presents Clinical Data for TERLIVAZ® (terlipressin) for Injection in Adults with Hepatorenal Syndrome (HRS) at Digestive Disease Week (DDW) 2023

Retrieved on: 
Monday, May 8, 2023
Gastrointestinal disease, Bradycardia, Use, HRS, Aes, Cardiovascular disease, MNK, Arrhythmia, DDW, Incidence, SS-N-22, Alcoholic hepatitis, Hepatorenal syndrome, Patient, Boxed warning, Virginia Commonwealth University, Internal medicine, School, Kidney, Terlipressin, NYSE, Pharmaceutical industry, Mallinckrodt

DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9. Mallinckrodt's pooled analysis of three North American Phase III studies on the incidence of adverse events (AEs) related to bradycardia and arrhythmias in adults with HRS treated with terlipressin was awarded Poster of Distinction status from DDW, and was presented on Sunday, May 7, 2023, 12:30 – 1:30 p.m. CDT.2 Additionally, Mallinckrodt's subgroup analysis of the CONFIRM Phase III study to assess terlipressin treatment outcomes in adults with HRS compounded by alcoholic hepatitis (AH) will be presented in an oral lecture session today, May 8, 2023, 10:30 – 10:45 a.m. CDT.3

Key Points: 
  • DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9.
  • The incidence of episodes of bradycardia was higher in terlipressin-treated patients (6.3%; n=22) compared with placebo-treated patients (0.8%; n=2; P
  • In CONFIRM (n=300), 41% (81/199) of patients in the terlipressin group and 39% (39/101) of the patients in the placebo group had AH at baseline.
  • In the subgroup of patients with AH (n=120), the median Maddrey discriminant function score was similar across treatment groups (terlipressin: 96.9 vs. placebo: 97.7; P=0.681).

ZyVersa Therapeutics Announces a Publication in Hepatology Revealing That Alcohol-induced Extracellular ASC Specks Perpetuate Liver Inflammation and Damage in Alcoholic Hepatitis

Retrieved on: 
Thursday, May 4, 2023
ASC, NLRP3, Inflammation, Super Meat Boy, AH, Alcoholic hepatitis, Mouse, Liver, Therapy, Hepatitis, Phosphorus, Liquor

Reported data demonstrate a central role of NLRP3 and ASC in alcohol-induced liver inflammation, and highlight the critical role of extracellular ASC specks in the propagation of systemic and liver inflammation in AH

Key Points: 
  • Reported data demonstrate a central role of NLRP3 and ASC in alcohol-induced liver inflammation, and highlight the critical role of extracellular ASC specks in the propagation of systemic and liver inflammation in AH
    WESTON, Fla., May 04, 2023 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces publication of an article in the peer-reviewed journal, Hepatology, supporting the critical role of extracellular ASC specks in propagating damaging liver inflammation in AH.
  • In the paper titled, “Alcohol-induced extracellular asc specks perpetuate liver inflammation and damage in alcoholic hepatitis even after alcohol cessation,” the authors reported that alcohol consumption induces NLRP3 inflammasome activation in the liver, and alcohol binges additionally increase circulating extracellular ASC specks and hepatic ASC aggregates leading to perpetuation of damaging inflammation.
  • Given the lack of specific treatment for AH, our data support NLRP3 as a therapeutic target in AH.” To read the article, Click Here .
  • “The research published in Hepatology demonstrating that alcohol-induced extracellular ASC specks perpetuate liver inflammation and damage provides support for targeting inflammasome ASC with IC 100, which has been shown to disrupt the structure and function of both intra- and extracellular ASC specks,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President.