FVC

Avalyn Presents Clinical Data on AP01 for Pulmonary Fibrosis, Including Long-Term Efficacy and Imaging Biomarker Data, at ATS 2024

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月曜日, 5月 20, 2024
Lazarus, Rash, Patient, Diarrhea, Theme, Data, Risk, FVC, Nausea, PPF, FCCP, Disease, Safety, Poster, Conference, American Thoracic Society, Efficacy, Idiopathic pulmonary fibrosis, Indigestion, Pulmonary fibrosis, Biomarker, ATLAS, ATS, B48, Fatigue, IPF, WRVS, Vomiting, Pharmaceutical industry

CAMBRIDGE, Mass., May 20, 2024 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Avalyn), a clinical-stage biopharmaceutical company focused on development of inhaled therapies for treatment of life-threatening pulmonary diseases, today presented clinical data for AP01, its novel formulation of inhaled pirfenidone, for the treatment of pulmonary fibrosis, supporting the Company’s planned Phase 2b trial in patients with progressive pulmonary fibrosis (PPF). Analysis from Avalyn’s ongoing ATLAS open-label extension study demonstrated that treatment with AP01 stabilized forced vital capacity (FVC) in patients with both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), with enhanced safety and tolerability compared to oral pirfenidone. Furthermore, findings from post-hoc analyses examining disease progression and Brainomix’s e-Lung biomarker scores support the Company’s selected dosing of 100 mg twice-daily and 50 mg twice-daily in the planned Phase 2b study.

Key Points: 
  • The data were presented in multiple poster presentations and featured events during the 2024 American Thoracic Society (ATS) International Conference held May 17-22, 2024, in San Diego, CA.
  • “Having dedicated decades to treating patients with respiratory diseases, I’ve seen firsthand the pressing need for new treatments.
  • Our excitement stems from the long-term data with AP01 that shows treatment of patients out to nearly four years, surpassing the average survival rates for patients with progressive disease.
  • These data support Avalyn’s selection of AP01 100 mg twice-daily and 50 mg twice-daily for the Company’s planned Phase 2b clinical trial.

Arrowhead Pharmaceuticals Presents New Clinical Data Showing ARO-RAGE Achieves High Level of Gene Knockdown in Patients with Asthma

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月曜日, 5月 20, 2024
Research, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Molecule, Lung, Patient, Arrowhead, Asthma, FVC, Pharmacodynamics, NHV, Safety, RAGE, Conference, Serum, American Thoracic Society, H5N1, TSLP, BALF, Interim, RNA interference, ATS, ARO, Gastric lavage, DLCO, FEV1, Pharmaceutical industry

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that new interim clinical data on ARO-RAGE, an investigational RNAi-based medicine for the treatment of inflammatory lung diseases, such as asthma, were presented at the American Thoracic Society (ATS) 2024 International Conference.

Key Points: 
  • Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that new interim clinical data on ARO-RAGE, an investigational RNAi-based medicine for the treatment of inflammatory lung diseases, such as asthma, were presented at the American Thoracic Society (ATS) 2024 International Conference.
  • “These results underscore the potential of our proprietary TRiMTM platform to enable us to develop impactful new therapies to potentially treat multiple pulmonary diseases with significant unmet needs.
  • Arrowhead also presented preclinical data on two additional lung targeted programs that utilize the company’s proprietary Targeted RNAi Molecule (TRiMTM) platform.
  • ARO-IAV is designed to silence expression of highly conserved influenza A viruses, including the highly pathogenic avian influenza virus (H5N1).

Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

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月曜日, 5月 6, 2024
Idiopathic pulmonary fibrosis, FVC, Investment, Hospital, Safety, Primary sclerosing cholangitis, Research, IPF, Collagen, Trial of the century, PET, Acceleration, DMD, Tumor microenvironment, PSC, European, Novartis, Week, Therapy, Vital capacity, Muscular dystrophy, Patient, TGF, Fibrosis, Cirrhosis, Integrin, Duchenne muscular dystrophy, Biomarker, Ethics committee, Massachusetts General Hospital, ELF, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported first quarter 2024 financial results.

Key Points: 
  • As part of the adaptive Phase 2b/3 implementation, the Phase 2b portion of BEACON-IPF was upsized from 267 patients to 360 patients.
  • Enrollment is progressing and we expect to complete enrollment of the upsized Phase 2b study expected in the first quarter of 2025.
  • The increase was due to higher operating expenses coupled with a decrease in collaboration revenues under the Novartis agreement during the quarter.
  • As of March 31, 2024, the Company had cash, cash equivalents and short-term investments of $483.9 million.

PureTech Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis

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火曜日, 4月 16, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, University of Southern California, FDA, Idiopathic pulmonary fibrosis, University, Vital capacity, FVC, Safety, Survival, IPF, CNS, Incidence, Patient, TID, Pirfenidone, Caregiver, Aes, Central nervous system, PRTC, Biomarker, Pharmacology, Pharmaceutical industry

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary fibrosis (IPF).
  • This PK profile and the resulting favorable tolerability have been demonstrated across multiple clinical trials in more than 400 individuals.
  • PureTech believes the results of the Phase 2b trial, together with an additional Phase 3 trial, could serve as the basis for registration in the U.S. and other geographies.
  • PureTech would like to extend its gratitude to those participating in the ELEVATE IPF trial, especially the people living with IPF and their caregivers, the clinical trial sites, investigators and advocacy groups.

First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis

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金曜日, 3月 22, 2024
PET/CT, Contract research organization, Biotechnology, Sarcoidosis, Disease, Patient safety, Patient, Tablet, Spirometry, Messenger, Quality of life, Biology, Royal, Fibrosis, Clinical trial, European, Arrest, Safety, Pharmacokinetics, MOC, Phase, KITE, FDA, FVC, ECG, Granuloma, Pharmaceutical industry

The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.

Key Points: 
  • The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.
  • As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks.
  • Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry.
  • The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
水曜日, 3月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
水曜日, 3月 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

NS Pharma, Inc. Shares New VILTEPSO® (Viltolarsen) Data at the MDA Clinical & Scientific Conference 2024

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水曜日, 3月 6, 2024
Duchenne, Research, MD, Duchenne muscular dystrophy, Trial of the century, Vital capacity, Conference, Annual general meeting, AAN, Muscular Dystrophy Association, Patient, FVC, Poster, MDA, Episcopal conference, American Academy, Pharmaceutical industry

PARAMUS, N.J., March 6, 2024 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6. The company presented a poster entitled "Pulmonary and motor function in ambulatory and non-ambulatory participants with Duchenne muscular dystrophy (Duchenne) treated with viltolarsen (VILTEPSO®)" which covers data from the Galactic53 trial demonstrating that the majority of participants receiving viltolarsen experienced meaningful benefit in pulmonary function, including percent predicted forced vital capacity (FVC%p).

Key Points: 
  • PARAMUS, N.J., March 6, 2024 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma) is excited to announce participation in the 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida, March 3 – 6.
  • "Galactic53 is the first trial with VILTEPSO to evaluate pulmonary function in participants with Duchenne," explains NS Pharma Vice President Medical Affairs & Pharmacovigilance Leslie Magnus, MD, who also co-authored the poster.
  • "Our team is encouraged by these results and will continue our research into treatments for rare disease."
  • Additional data from this study will also be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting, April 13 – 18 in Denver, Colorado and online.

AnaCredit Validation Checks – Version 1.8

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日曜日, 1月 28, 2024
Sale, Commitment, Logic, Record, Default, Central bank, Date, MFI, AnaCredit, Validation, Probability, Instrument, Inception, Encumbrance, Collection, Part Two, DOES, NCB, Element, Section 4, T-3, NOT, Accounting, Creditor, Language, ECB, Fahd of Saudi Arabia, Classification, LEI, Completeness, Table, NCBS, Definition, FVC, European Central Bank, Protection, Ultimate, Section, Data collection, ID, Data, Data set, Commission, Interest, Communication, Next, Prudential, GAAP, OJ, Head, Boilermaker
Key Points: 

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DRI International Releases 9th Annual Predictions Report, Highlighting Risk and Resilience Trends in 2024

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水曜日, 1月 10, 2024
Eye, International, Radar, Environment, DRI, FVC, Management

NEW YORK, Jan. 10, 2024 /PRNewswire/ -- Disaster Recovery Institute (DRI) International, the leading nonprofit in business continuity and resilience training, has published its Ninth Annual Predictions Report – resilience predictions for the profession, by the profession.

Key Points: 
  • NEW YORK, Jan. 10, 2024 /PRNewswire/ -- Disaster Recovery Institute (DRI) International, the leading nonprofit in business continuity and resilience training, has published its Ninth Annual Predictions Report – resilience predictions for the profession, by the profession.
  • The report provides a look ahead to major global issues that resilience professionals may deal with in the coming year.
  • The report provides an in-depth look ahead to major global issues that resilience professionals may deal with in the coming year.
  • It was developed by the DRI Future Vision Committee (FVC), a group of international thought leaders in the field.