Fibrosis

Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
SAN, Lipoprotein, EFX, Research, Liver injury, Marketing, FDA, Biopsy, Cirrhosis, Safety, MASH, Histology, Therapy, DSM-IV codes, Patient, Fibrosis, Pharmaceutical industry

SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).

Key Points: 
  • SYNCHRONY Histology is evaluating the safety and efficacy of 28 and 50mg doses of efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic MASH (F2-F3).
  • Additional patients will be enrolled and followed for long-term clinical outcomes to support an application for full marketing approval.
  • In the fourth quarter of 2023, Akero reported results for the week 36 analysis of the Phase 2b SYMMETRY study in patients with cirrhosis due to MASH.
  • Akero's cash, cash equivalents, short-term and long-term marketable securities for the year ended December 31, 2023 were $569.3 million.

Madrigal Pharmaceuticals Provides Corporate Updates and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024
CFO, Therapy, Research, Biotechnology, Accounting, FP, AASLD, PDUFA, Cirrhosis, Safety, Portola Pharmaceuticals, Abstract (summary), Liver disease, Health, Patient, Fibrosis, Medicine, Disease, NASH, G&A, Fatty liver disease, Pharmaceutical industry

Announced appointment of Mardi C. Dier as Chief Financial Officer

Key Points: 
  • Announced appointment of Mardi C. Dier as Chief Financial Officer
    Anticipates resmetirom to become the first medicine approved for NASH; PDUFA date March 14, 2024
    CONSHOHOCKEN, Pa., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today provides a summary of corporate updates and reports fourth quarter and full year 2023 financial results.
  • She has held CFO positions at Portola Pharmaceuticals, Ultragenyx, and Acelyrin.
  • Five Madrigal health economic abstracts were presented at the NASH-TAG conference, which took place January 4-6, 2024 in Park City, Utah.
  • Financial Results for the Three and Twelve Months Ended December 31, 2023
    As of December 31, 2023, Madrigal had cash, cash equivalents and marketable securities of $634.1 million, compared to $358.8 million at December 31, 2022.

Tenaya Therapeutics Announces Publication of Preclinical HDAC6 Inhibitor Data for Heart Failure with Preserved Ejection Fraction in Nature Communications

Retrieved on: 
Monday, February 26, 2024
SAN, Metabolism, Inflammation, Food, HDAC6, HDAC, Exercise, Tubulin, Heart failure, Safety, Therapy, Acetylation, Patient, Hypertrophy, Fibrosis, SGLT2, MTAC, Oxidative stress, Nature Communications, Heart, HFD, Plasma, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced the publication of preclinical research related to Tenaya’s small molecule inhibitors of histone deacetylase 6 (HDAC6), including TN-301, in the February 26, 2024, issue of Nature Communications. The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.

Key Points: 
  • The article, titled “Targeting HDAC6 to Treat Heart Failure with Preserved Ejection Fraction in Mice,” details the potential of inhibiting HDAC6 for the treatment of Heart failure with preserved ejection fraction (HFpEF), a form of heart failure that effects more than three million people in the U.S. alone1.
  • Tenaya’s highly selective small molecule inhibitors of the enzyme HDAC6 were discovered using the company’s modality-agnostic target discovery and validation capabilities.
  • For preclinical studies, Tenaya researchers used TYA-018, an HDAC6 inhibitor structurally and functionally similar to the company’s clinical candidate, TN-301.
  • The selective effects of HDAC6 inhibition were reaffirmed through genetic deletion studies, in which treatment of Hdac6 knockout mice did not display any of the beneficial effects that wild-type HFpEF mice did following treatment.

Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis

Retrieved on: 
Monday, February 26, 2024
Fibrosis, Obesity, MASH, Boehringer Ingelheim, Zealand Pharma, Pharma, Liver disease, Fine chemical

The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring).

Key Points: 
  • The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring).
  • Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis.
  • The double-blind, placebo-controlled Phase 2 trial studied three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial.
  • Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0 mg.

aTyr Pharma Announces Expanded Access Program (EAP) for EFZO-FIT™ Clinical Trial Participants

Retrieved on: 
Wednesday, February 21, 2024
SAN, Sarcoidosis, Scar, Small RNA, Pi, ATyr Pharma, FDA, Inflammation, Food, Scleroderma, Risk, Myelocyte, Health, Safety, Principal investigator, Expanded access, Neuropilin, Systemic scleroderma, ILD, OLE, Patient, Fibrosis, Clinical trial, EAP, Pharmaceutical industry

SAN DIEGO, Feb. 21, 2024 (GLOBE NEWSWIRE) --  aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced plans to initiate an Individual Patient Expanded Access Program (EAP) for its lead therapeutic candidate, efzofitimod, for patients with pulmonary sarcoidosis. The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.

Key Points: 
  • Individual Patient EAP allows access to efzofitimod for patients who complete the Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis.
  • Company initiating program based on blinded EFZO-FIT™ study investigator and patient participant feedback.
  • The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.
  • “We are pleased to make efzofitimod available to patients beyond the duration of the EFZO-FIT™ clinical trial through this Individual Patient EAP,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

Certa Therapeutics’ FT011 Granted US FDA Fast Track for the Treatment of Systemic Sclerosis

Retrieved on: 
Monday, February 19, 2024
Fast Track, EMA, Biotechnology, Scleroderma, FDA, Food, Treatment, Marker beacon, Therapy, GPCR, Patient, Acceleration, Fibrosis, Clinical trial, Disease, NDA, Pharmaceutical industry

MELBOURNE, Australia, Feb. 19, 2024 (GLOBE NEWSWIRE) -- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation.

Key Points: 
  • MELBOURNE, Australia, Feb. 19, 2024 (GLOBE NEWSWIRE) -- Certa Therapeutics (Certa), a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational therapy FT011 for the treatment of systemic sclerosis (scleroderma), having previously granted Orphan Drug Designation.
  • [4]
    Professor Darren Kelly, Certa Therapeutics CEO and founder said, “We are thrilled to have received Fast Track Designation which supports further acceleration of the FT011 clinical development program.
  • Certa is progressing preparations toward a pivotal clinical trial of FT011 as a treatment for scleroderma.
  • C Denton, W Stevens, N Kruger, M Papadimitriou, F Khong, M Bradney, D Kelly, R Lafyatis “FT011 for the Treatment of Systemic Sclerosis.

Seek Labs Welcomes Alison O’Mahony, PhD as new Vice President of Pharmaceutical Research

Retrieved on: 
Thursday, February 22, 2024
General Health, Health, Science, Pharmaceutical, Research, Bachelor of Science, Woman, Doctor of Philosophy, Seek, STEM, WITS, Inflammation, Drug discovery, Global health, University College Cork, Patient, Fibrosis, Knowledge, Microbiology, Recursion, Pharmaceutical industry

Seek Labs, a healthcare innovations company developing next-generation molecular diagnostic systems and novel gene therapies, announced today the appointment of Alison O’Mahony, PhD as Vice President of Pharmaceutical Development.

Key Points: 
  • Seek Labs, a healthcare innovations company developing next-generation molecular diagnostic systems and novel gene therapies, announced today the appointment of Alison O’Mahony, PhD as Vice President of Pharmaceutical Development.
  • With nearly 20 years of experience in R&D, phenotypic drug discovery, and assay and scientific operations, O’Mahony brings extensive knowledge and expertise to Seek Labs where she will spearhead the pharmaceutical research division, leading strategic initiatives to advance Seek Labs’ innovation in novel gene therapies.
  • "We are delighted to welcome Alison O’Mahony to Seek Labs as our new Vice President of Pharmaceutical Development," said Jared Bauer, CEO.
  • She also serves on professional boards including Talent Ready Utah, Breakthrough Cancer Research, and the Inflammation Research Association.

New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System

Retrieved on: 
Wednesday, February 21, 2024
FDA, Health, Diabetes, Surgery, Health Insurance, Pharmaceutical, Therapy, CE, American Diabetes Association, NAFLD, Endocrinology, T2D, Research, Medicine, Person, CMS, Non-alcoholic fatty liver disease, Liver disease, NDRA, Prediabetes, Obesity, Cardiovascular disease, Food, ALT, De novo, Global health, Weill Cornell Medicine, Risk, Hepatology, Cirrhosis, European, Prevalence, Ultrasound, World Health Organization, Medicare, Type 2 diabetes, Metabolic syndrome, Patient, Fibrosis, Primary care, Fatty liver disease, NASH, Diagnosis, Knowledge Organization (journal), WHO, International Classification of Diseases, Dietary supplement

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.

Key Points: 
  • The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes.
  • These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary.
  • The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis.
  • "This positive development is testament to the growing awareness of liver health and the intensifying need for effective diagnostic solutions.

NorthSea Therapeutics Initiates Phase 2A Trial of Orziloben (NST-6179) in Intestinal Failure-Associated Liver Disease (IFALD)

Retrieved on: 
Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Liver, Collagen, Myofibroblast, PD, Liver disease, Cirrhosis, Learning, Short bowel syndrome, Conference, Hepatology, Liver failure, Safety, Steatosis, Rigshospitalet, PN, Therapy, Pharmacokinetics, Cholestasis, Fatty liver disease, Patient, ASPEN, Fibrosis, Disease, NASH, Pharmaceutical industry

The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.

Key Points: 
  • The trial is a randomized, double-blind, Phase 2a, placebo-controlled study, which will be conducted at multiple sites across North America.
  • It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Orziloben in adult subjects with IFALD.
  • Commenting on the milestone, Rob de Ree, NST’s CEO, said: "Dosing the first patient in our Phase 2a trial for Orziloben in IFALD is a significant achievement for NorthSea Therapeutics, and is a testament to our commitment to advance innovative treatments for liver diseases.
  • In one pre-clinical model of PN-induced liver injury, Orziloben treatment completely prevented severe cholestasis and the development of fibrosis.

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
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, SNY, SAN, Ulcerative colitis, Crohn's disease, TEVA, Inflammation, European, Teva, Teva Pharmaceuticals, Asthma, Gastrointestinal tract, Safety, UC, Immunoglobulin G, Inflammatory bowel disease, Patient, Fibrosis, TL1A, IBD, Medication, TNF, ECCO, Pharmaceutical industry

“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.