Myofibroblast

FDA Grants Orphan Drug Designation for the Treatment of Scleroderma

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星期四, 四月 11, 2024
Collagen, Pain, FDA, Mortality, University, Patient, RFU, Systemic scleroderma, Risk, Skin, Food, Death, Helix, BLR, Research, Disease, Scleroderma, Rheumatology, Fatigue, Fibrosis, Public, Rheumatism, Multimedia, Myofibroblast, Pharmaceutical industry

NORTH CHICAGO, Ill., April 11, 2024 /PRNewswire/ -- BLR Bio, an emerging biotechnology company in Rosalind Franklin University's Helix 51 biomedical incubator , announced that the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for its investigational therapy BLR-200 for the treatment of systemic sclerosis (SSc), also known as scleroderma.

Key Points: 
  • NORTH CHICAGO, Ill., April 11, 2024 /PRNewswire/ -- BLR Bio, an emerging biotechnology company in Rosalind Franklin University's Helix 51 biomedical incubator , announced that the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for its investigational therapy BLR-200 for the treatment of systemic sclerosis (SSc), also known as scleroderma.
  • Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S.
  • "The FDA's granting of Orphan Drug Designation to BLR-200 highlights the urgent need for new and innovative therapeutic options for patients afflicted with the disease."
  • Dr. Ronald Kaplan, RFU executive vice president for research, said the orphan designation represents an important milestone in the development of BLR Bio's drug candidate.

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

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星期三, 二月 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.

Anima Biotech Announces Preclinical Data of Candidate in Idiopathic Pulmonary Fibrosis

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星期三, 二月 7, 2024
Extracellular matrix, Tech, Cell, Eli Lilly, AI, Phenotype, Biomarker, Patient, Fibroblast, Idiopathic pulmonary fibrosis, Drug discovery, Messenger, Myofibroblast, AbbVie, Disease, IPF, ADMET, Pharmaceutical industry

BERNARDSVILLE, N.J., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Anima Biotech, the Tech.Bio leader bringing AI to mRNA biology, announced today positive preclinical data of its lung fibrosis candidate.

Key Points: 
  • BERNARDSVILLE, N.J., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Anima Biotech, the Tech.Bio leader bringing AI to mRNA biology, announced today positive preclinical data of its lung fibrosis candidate.
  • This drug operates through a novel mRNA biology mechanism of action, opening new avenues for treating Idiopathic Pulmonary Fibrosis (IPF) patients.
  • Utilizing its mRNA Lightning™ Platform, Anima has successfully identified a preclinical candidate operating through a novel mRNA biology mechanism of action, effectively disrupting the transformation of fibroblasts into fully differentiated myofibroblasts.
  • By inhibiting myofibroblasts' deposition of extracellular matrix, this candidate demonstrates substantial potential in mitigating fibrotic diseases.

Chemomab Therapeutics Announces New Publication Reinforcing the Clinical Potential of Its CCL24-Neutralizing Antibody CM-101 in Primary Sclerosing Cholangitis

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星期二, 一月 30, 2024
CCL24, Pathology, Role, Neutrophil, Patient, European, Therapy, Primary sclerosing cholangitis, Fibrosis, CMMB, Proteomics, In vitro, Potential, Orphan drug, CCL11, PSC, Myofibroblast, Health, TEL, Cell, Disease, CCL26, Fast Track, FDA, Protein, Doctor of Philosophy, Inflammation, Monocyte, Pharmaceutical industry

TEL AVIV, Israel, Jan. 30, 2024 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced publication of proteomic analyses that further demonstrate the unique role of the soluble protein CCL24 in driving pathologies associated with the rare fibrotic liver disease primary sclerosing cholangitis (PSC). The new studies reinforce the extensive existing evidence showing that Chemomab's first-in-class CCL24-neutralizing antibody CM-101 can interrupt these destructive processes. The study, "The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data"1 has been published in the current online version of the peer-reviewed journal Cells.

Key Points: 
  • The new studies reinforce the extensive existing evidence showing that Chemomab's first-in-class CCL24-neutralizing antibody CM-101 can interrupt these destructive processes.
  • The study, " The Role of CCL24 in Primary Sclerosing Cholangitis: Bridging Patient Serum Proteomics to Preclinical Data "1 has been published in the current online version of the peer-reviewed journal Cells.
  • CM-101 is a first-in-class CCL24-neutralizing monoclonal antibody whose dual anti-inflammatory and anti-fibrotic activity has demonstrated disease modifying potential in nonclinical studies of PSC and other fibro-inflammatory disorders.
  • CM-101 has Orphan Drug designation for PSC in the U.S. and the European Union and was recently awarded Fast Track designation by the FDA for the treatment of PSC in adults.

Pliant Therapeutics Presentations at The Liver Meeting® 2023 Highlight Bexotegrast, an Inhibitor of αvß6 and αvß1 Integrins, in Primary Sclerosing Cholangitis

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星期一, 十一月 13, 2023
Primary biliary cholangitis, Hepatology, SAN, Myofibroblast, Therapy, PSC, Primary sclerosing cholangitis, PBC, Cirrhosis, AASLD, Toronto Centre, ALK5, Patient, Wound healing, Liver disease, Gene expression, TGF, Liver, Non-alcoholic fatty liver disease, Fibrosis, Trial of the century, ELF, Integrin, Safety, Pharmaceutical industry

These posters were presented at The Liver Meeting® 2023 of the American Association for the Study of Liver Diseases (AASLD).

Key Points: 
  • These posters were presented at The Liver Meeting® 2023 of the American Association for the Study of Liver Diseases (AASLD).
  • “Our presentations at the Liver Meeting feature preclinical and clinical work supportive of bexotegrast’s antifibrotic mechanism of action in liver fibrosis,” said Éric Lefebvre, M.D., Chief Medical Officer of Pliant.
  • An αVβ1-selective integrin inhibitor was evaluated on fibrotic and non-fibrotic human liver tissue to assess the effects on cell populations present in fibrotic human liver tissue.
  • The effects of bexotegrast (PLN-74809), a dual inhibitor of integrins αVβ6 and αVβ1, were assessed on human liver tissue to characterize the response of unique cell populations in fibrotic primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).

Endeavor BioMedicines Completes Enrollment in Phase 2a Clinical Trial of ENV-101 (Taladegib) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

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星期三, 九月 6, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Pathology, FVC, Cell, Myofibroblast, Lung, Fibrosis, Vital capacity, Patient, Disease, Entrepreneurship, Mortality, IPF, Idiopathic pulmonary fibrosis, Safety, Pharmaceutical industry, Hedgehog

Endeavor BioMedicines , a clinical-stage company targeting the drivers of fibrosis and oncology, today announced that the company has completed enrollment in its Phase 2a clinical trial to evaluate the safety and efficacy of ENV-101 (taladegib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Key Points: 
  • Endeavor BioMedicines , a clinical-stage company targeting the drivers of fibrosis and oncology, today announced that the company has completed enrollment in its Phase 2a clinical trial to evaluate the safety and efficacy of ENV-101 (taladegib) for the treatment of idiopathic pulmonary fibrosis (IPF).
  • ENV-101 is a small-molecule inhibitor of the Hedgehog (Hh) signaling pathway, which plays a critical role in IPF disease pathology.
  • “This enrollment milestone is an important achievement, and we look forward to reporting topline results in Q1 of 2024.
  • Selectively inhibiting this pathway in lung tissue induces myofibroblast apoptosis, thereby eliminating the key cellular driver of IPF.

180 Life Sciences Issues Letter to Stockholders

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星期一, 九月 26, 2022
Safety, Hardness, POCD, Patient, Clinical trial, Investment, File, NIHR, Drug development, Celltrion, NASDAQ, Investigational New Drug, Research, PALO, Adalimumab, Inflammation, Disease, National Institute, Fibrosis, Food, Company, Growth, Myofibroblast, Intellectual property, Annual report, Life, Behavior, Health care, SEC, Patent, TNF, Risk, FDA, Finger, IND, Diabetes, Hand, MHRA, Downregulation and upregulation, Security (finance), GLOBE, HIV disease progression rates, Nasdaq, Program, Letter, Regulation of tobacco by the U.S. Food and Drug Administration, List of life sciences, Cell, Compte rendu, Private Securities Litigation Reform Act, Smoking, Infliximab, Recurrence, Pharmaceutical industry, Vaccine, EU

PALO ALTO, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF) (180 Life Sciences or the Company), a clinical-stage biotechnology company today released the following letter to stockholders from its Chief Executive Officer, Dr. James Woody.

Key Points: 
  • PALO ALTO, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF) (180 Life Sciences or the Company), a clinical-stage biotechnology company today released the following letter to stockholders from its Chief Executive Officer, Dr. James Woody.
  • In that letter, I provided an update regarding the Companys clinical development plans, which remained on track then, and continue to remain on track today.
  • As a reminder, 180 Life Sciences was founded on the belief that novel anti-inflammatory biologics that are already approved, such as anti-tumor necrosis factor (TNF), or adalimumab, could have the potential to address large unmet needs for a variety of additional indications.
  • About 180 Life Sciences Corp.
    180 Life Sciences Corp. is a clinical-stage biotechnology company driving ground-breaking studies into clinical programs which are seeking to address major unmet medical needs.

Blade Therapeutics Presents Analyses from Phase 1 and Preclinical Studies of Cudetaxestat at the European Respiratory Society International Congress 2022

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星期日, 九月 4, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Mortality, LPA, COVID-19, HIV disease progression rates, International Congress on Tuberculosis, Liver, Therapy, Autotaxin, Disease, Kidney, PK, ERS, Poster, LPC, European Respiratory Society, Myofibroblast, LinkedIn, Diagnosis, Matrix, Interstitial lung disease, Lung, PDF, Fibrosis, PD, International, FDA, Neurodegeneration, NASH, IPF, Clinical trial, Patient, Idiopathic pulmonary fibrosis, Pharmaceutical industry

The data were featured in a poster (abstract #PA459) presented today at the European Respiratory Society (ERS) International Congress 2022, which is taking place in Barcelona, Spain, from September 4-6, 2022.

Key Points: 
  • The data were featured in a poster (abstract #PA459) presented today at the European Respiratory Society (ERS) International Congress 2022, which is taking place in Barcelona, Spain, from September 4-6, 2022.
  • Data analyses were included from a battery of preclinical studies that assessed the potency and activity of cudetaxestat, and four Phase 1 studies of healthy volunteers (N=216) that evaluated safety/tolerability along with pharmacokinetic (PK) and pharmacodynamic (PD) activity.
  • Results of analyses from preclinical studies showed that cudetaxestat maintained potency against its target in vitro regardless of substrate (lysophosphatidylcholine, or LPC) concentration and demonstrated significant anti-fibrotic activity in multiple in vivo preclinical models.
  • For additional information about the ERS International Congress 2022, please visit the website .

REPEAT - 180 Life Sciences and University of Oxford Announce Publication of Positive Phase 2b Dupuytren’s Disease Study Results in The Lancet Rheumatology

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星期一, 五月 2, 2022
Fibrosis, TNF, Department, Myofibroblast, University, Pain, NASDAQ, GLOBE, Finger, Global Health Innovative Technology Fund, Injection, Patient, Hand, Clinical trial, Adalimumab, List of life sciences, History, Wellcome Trust, Department of Health and Social Care, Hardness, Disease, Inflammation, Social work, Pharmaceutical industry, EU

Roughly 12 million patients in the U.S., 2.5 million in the U.K. and 22 million in the EU have Dupuytrens disease.

Key Points: 
  • Roughly 12 million patients in the U.S., 2.5 million in the U.K. and 22 million in the EU have Dupuytrens disease.
  • We believe that these results herald a dramatic change in treatment options for Dupuytrens disease, said Professor Sir Marc Feldmann, Founder and Co-Chairman of 180 Life Sciences.
  • J. Nanchahal, Anti-Tumour Necrosis Factor Therapy for Early Stage Dupuytrens Disease (RIDD): a phase 2b randomised double blind, placebo-controlled trial.
  • 180 Life Sciences is one of the leaders into solving one of the worlds biggest drivers of disease inflammation.

Blade Therapeutics Announces Feedback from FDA on End-of-Phase 1 Data Package

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星期一, 四月 4, 2022
Research, Mental Health, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, Risk, Therapy, Fibrosis, Biomarker, Cayman Islands, Neurodegeneration, Liver, SEC, Probability, CEO, IPF, Knowledge, Securities Act of 1933, Matrix, Business architecture, BIOT, Autotaxin, Disease, Bristol Myers Squibb, Proxy, Sale, Trial of the century, Kidney, Myofibroblast, Vital capacity, Aggregation, NASH, Combined, NASDAQ, Lung, Form, Investment, Transaction, Forward-looking statement, Mortality, LPA, BAC, Failure, Prospectus, POC, FDA, Interstitial lung disease, Patient, Company, LinkedIn, Institute of Liver and Biliary Sciences, HIV disease progression rates, PIPE, Safety, COVID-19, Acquisition, Pharmaceutical industry, Financial services, Security (finance), Audit, Risk management, Nasdaq, Blade, Target, BLADE THERAPEUTICS, BIOTECH ACQUISITION COMPANY

The FDA response letter outlined requirements for a proposed phase 2 PoC/dose ranging study for use of cudetaxestat in patients with IPF.

Key Points: 
  • The FDA response letter outlined requirements for a proposed phase 2 PoC/dose ranging study for use of cudetaxestat in patients with IPF.
  • We are pleased with the guidance provided by the FDA, said Wendye Robbins, M.D., president and CEO of Blade.
  • Available data from completed phase 1 studies in healthy volunteers showed that cudetaxestat was well tolerated with a demonstrated pharmacokinetic/pharmacodynamic correlation and biomarker activity.
  • Cudetaxestat is an investigational medicine that is not approved for commercial use by the FDA or any other regulatory authority.