Fibrosis

AKRO Investor Notice: Abraham, Fruchter & Twersky, LLP Investigating Claims on Behalf of Investors of Akero Therapeutics (NASDAQ:AKRO)

Retrieved on: 
Wednesday, March 20, 2024
Notice, Patient, Fibrosis, News, LLP, Åkerö, Learning, Investor's Business Daily

The result wasn’t statistically significant.” On this news, Akero stock fell sharply.

Key Points: 
  • The result wasn’t statistically significant.” On this news, Akero stock fell sharply.
  • Abraham, Fruchter & Twersky, LLP (www.aftlaw.com) is a law firm based in New York and maintaining an office in California.
  • Abraham, Fruchter & Twersky, LLP has extensive experience in litigating on behalf of investors.
  • If you have any questions about this Notice, the investigation, your rights or your interests, please contact:

ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

Retrieved on: 
Monday, March 18, 2024
Alport syndrome, Diabetic nephropathy, VAR, Institutional review board, Lipid, Patient, Focal segmental glomerulosclerosis, Kidney disease, Fibrosis, Clinical trial, Kidney, Therapy, Chronic kidney disease, Safety, Dialysis, Cholesterol, IRB, Pharmaceutical industry

Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.

Key Points: 
  • Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
  • WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, announces Institutional Review Board (IRB) approval of the Phase 2a clinical trial protocol to evaluate the efficacy and safety of Cholesterol Efflux Mediator VAR 200 in patients with diabetic kidney disease.
  • It is the first in human trial for VAR 200 intended to substantiate that the promising preclinical results demonstrated in three different animal models of kidney disease (diabetic kidney disease, focal segmental glomerulosclerosis, and Alport syndrome) translate to patients with kidney disease.
  • We are excited about the potential of Cholesterol Efflux MediatorTM VAR 200 to protect against kidney injury and reduce kidney disease progression.”

Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D

Retrieved on: 
Monday, March 18, 2024
Diagnosis, Glucose, Histology, Adipose tissue, Arm, Glycated hemoglobin, Type 2 diabetes, Disease, Connective tissue, Steatosis, Insulin, Weight gain, Diabetes, CT1, Patient, Inflammation, SGLT2, Adiponectin, Table, MASH, MD, Liver injury, Insulin resistance, LEGEND, Fibrosis, HDL, Fatty liver disease, Empagliflozin, Safety, Euronext Paris, Phase, NASH, Hepatitis, Lipid metabolism, Prediabetes, Liver disease

Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.

Key Points: 
  • Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.
  • The treatment with lanifibranor 800mg/once daily alone or in combination with empagliflozin for 24 weeks was well tolerated, with no safety concerns reported.
  • The trial is double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm.
  • More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Fatty liver disease, Cirrhosis, Exercise, Entrepreneurship, Liver disease, Physician, F2, Patient, Research, Diet, Fibrosis, Drug development, NASH, Therapy, NAFLD, FDA, THR, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
  • Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.

Aileron Therapeutics Announces CEO Transition

Retrieved on: 
Tuesday, March 12, 2024
Science, Acquisition, ALRN, University, Doctor of Philosophy, Fibrosis, Therapy, Management

WALTHAM, Mass., March 12, 2024 (GLOBE NEWSWIRE) -- Aileron Therapeutics, Inc. (“Aileron”) (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that current President and Chief Operating Officer, Brian Windsor, Ph.D., has been appointed President and Chief Executive Officer (CEO) and will join the Board of Directors, effective March 11, 2024. Dr. Windsor succeeds Manuel Aivado, M.D., Ph.D., who has stepped down as CEO and will continue to serve on the Company’s Board of Directors. The transition follows the Company’s acquisition of Lung Therapeutics, Inc. (“Lung”) in October of last year.

Key Points: 
  • Dr. Windsor succeeds Manuel Aivado, M.D., Ph.D., who has stepped down as CEO and will continue to serve on the Company’s Board of Directors.
  • The transition follows the Company’s acquisition of Lung Therapeutics, Inc. (“Lung”) in October of last year.
  • Prior to Aileron, he served as President, CEO and director of Lung.
  • “I am honored to assume the role of CEO of Aileron, and am encouraged for its promising future,” said Dr. Windsor.

89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis

Retrieved on: 
Tuesday, March 12, 2024
Fatty liver disease, FGF21, Cirrhosis, Patient, SAN, Hepatology, University, MASH, Fibrosis, Safety, Division, NASH, Liver, Pharmaceutical industry

SAN FRANCISCO, March 12, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of its Phase 3 ENLIGHTEN Program evaluating the efficacy and safety of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). ENLIGHTEN-Fibrosis, the first of two Phase 3 trials in the program, has initiated and is evaluating non-cirrhotic MASH patients with fibrosis stage F2-F3.

Key Points: 
  • ENLIGHTEN-Fibrosis, the first of two Phase 3 trials in the program, has initiated and is evaluating non-cirrhotic MASH patients with fibrosis stage F2-F3.
  • “ENLIGHTEN-Fibrosis aims to enroll MASH patients, including those on background GLP-1-based therapies, where pegozafermin has demonstrated additional anti-fibrotic and metabolic effects.
  • The trial is designed to employ a three-panel consensus biopsy reading methodology, which was successfully utilized in the ENLIVEN trial.
  • Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.

Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

Retrieved on: 
Wednesday, April 3, 2024
Research, FDA, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Human, Obesity, Cirrhosis, CANF, Inflammation, Patient, MASH, Fibrosis, Fatty liver disease, Phase, NASH, Liver disease, Food, Pharmaceutical industry

Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.

Key Points: 
  • Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.
  • The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH.
  • The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint.
  • "We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite.

D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH

Retrieved on: 
Tuesday, April 2, 2024
FDA, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Overweight, D&D, Obesity, Patient, Fatty liver disease, Fast Track, Weight loss, MASH, Fibrosis, Type 2 diabetes, T2D, Safety, MAFLD, NASH, Liver disease, Food, Dietary supplement

FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.

Key Points: 
  • FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.
  • In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH.
  • “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D.
  • DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”

Liver-Assessment Tool Hepatoscope® Cleared for Use in U.S. and Europe Just as First Medication for MASH* Gains FDA Approval

Retrieved on: 
Tuesday, March 26, 2024
Software, Research, General Health, Medical Devices, Technology, Healthcare Reform, Science, Other Technology, FDA, Other Science, Health, Public Policy, Government, Diagnosis, Scripps Center, School corporal punishment, CE, Liver disease, Disease, Associate, Physician, F2, Risk, Cirrhosis, Patient, Syndrome, F3, Triage, Tool, Death, MASH, Fibrosis, LSM, Use, Multimedia, Hepatocellular carcinoma, Liver, Food, Medical imaging

This is a timely and exciting development in the fight against metabolism-related liver disease, which is on the rise globally.

Key Points: 
  • This is a timely and exciting development in the fight against metabolism-related liver disease, which is on the rise globally.
  • The economic burden attributed to effects of MASLD in the U.S. exceeds $100 billion annually.
  • “Medication that can reverse some of the worst impacts of MASH will be a huge help to our patients.
  • Questions of access matter more than ever,” he concluded, “as patients stand to benefit from these newer, more effective forms of treatment.”

AliveGen Announces Successful Completion of Phase 1b Multiple-Ascending Dose Clinical Trial for ALG-801

Retrieved on: 
Monday, March 18, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Atrophy, Clinical study design, Obesity, PD, DSM-IV codes, Weight, Liver disease, Doctor of Philosophy, MD, Trial of the century, Woman, Pharmacovigilance, Fibrosis, Clinical trial, TGF, Triple test, Chronic kidney disease, Therapy, Family, HQ, Pharmaceutical industry

AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.

Key Points: 
  • AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.
  • Study Design: The Phase 1b MAD study is a randomized double-blind placebo-controlled trial in postmenopausal women.
  • Next Step: Following the successful Phase 1b MAD study, AliveGen plans to advance ALG-801 to Phase 2 clinical development.
  • “We are grateful to the healthy volunteers and healthcare professionals who actively participated in our Phase 1b clinical trial,” said HQ Han, MD, PhD, CEO of AliveGen.