Latest news with #Qureight
Yahoo
20-05-2025
- Health
- Yahoo
Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis
Findings presented at the American Thoracic Society 2025 International Conference corroborate previous findings and provide important new clinical evidence supporting ENV-101 SAN DIEGO, May 20, 2025--(BUSINESS WIRE)--Endeavor BioMedicines ("Endeavor"), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today presented a post hoc analysis from the completed Phase 2a clinical trial of its lead investigational therapy, ENV-101 (taladegib). Results demonstrated a significant reduction in pulmonary vessel volume, a significant increase in lung volume, and a trend towards reduced lung fibrosis for idiopathic pulmonary fibrosis (IPF) patients treated with ENV-101 for 12 weeks vs. placebo. The analysis utilized Qureight's deep learning-based computed tomography (CT) analytics technologies and was presented in a poster presentation at the American Thoracic Society (ATS) 2025 International Conference. Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF. "These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease," said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. "We are grateful to the Qureight team for partnering with us on this important analysis." The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18). Key Results from the Post Hoc Analysis Presented at ATS 2025 Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87). Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64). Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28). "We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8," said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. "Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight's deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine." About the ENV-101 Phase 2a Clinical Trial Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile. About the WHISTLE-PF Trial Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound's safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines' investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X. View source version on Contacts Media: Audra Friis Sam Brown, Inc.917-519-9577audrafriis@ Sign in to access your portfolio
Business Wire
20-05-2025
- Business
- Business Wire
Endeavor BioMedicines Presents New Clinical Findings From Post Hoc Analysis of Phase 2a Clinical Trial Evaluating ENV-101 in Patients with Idiopathic Pulmonary Fibrosis
SAN DIEGO--(BUSINESS WIRE)-- Endeavor BioMedicines ('Endeavor'), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today presented a post hoc analysis from the completed Phase 2a clinical trial of its lead investigational therapy, ENV-101 (taladegib). Results demonstrated a significant reduction in pulmonary vessel volume, a significant increase in lung volume, and a trend towards reduced lung fibrosis for idiopathic pulmonary fibrosis (IPF) patients treated with ENV-101 for 12 weeks vs. placebo. The analysis utilized Qureight's deep learning-based computed tomography (CT) analytics technologies and was presented in a poster presentation at the American Thoracic Society (ATS) 2025 International Conference. Lung volume, fibrotic tissue volume and pulmonary vessel volume are all volumetric lung measures that can change during IPF disease progression or in response to treatment. Each measure has been established as an independent predictor of mortality. Deep learning-based quantification of lung volume and pulmonary vascular changes may offer valuable insights that corroborate physiological improvement in lung function and measure treatment outcomes with a greater effect size than forced vital capacity (FVC), the current registrational endpoint in IPF. A new finding from this post hoc analysis demonstrated a significant reduction in pulmonary vessel volume for patients in the ENV-101 treatment arm versus placebo. A reduction in pulmonary vessel volume has been correlated with improved mortality and decreased disease burden. To date, ENV-101 is the only therapeutic that has demonstrated a reduction in pulmonary vessel volume in patients with IPF, providing further evidence that ENV-101 has the potential to reverse disease across multiple measures of IPF. 'These findings provide additional evidence of clinical utility of ENV-101 in patients with IPF marking another step forward in our mission to restore hope and improve lives for those facing this otherwise devastating disease,' said Lisa Lancaster, M.D., Chief Medical Officer, Endeavor BioMedicines. 'We are grateful to the Qureight team for partnering with us on this important analysis.' The post hoc analysis of the Phase 2a trial was conducted using novel deep learning-based CT analysis technologies developed by Qureight Ltd (Cambridge, UK). Qureight used three deep learning models developed to quantify lung volume (Lung8), pulmonary vessel volume (Vascul8), and fibrosis extent (Fibr8) on the baseline and follow-up CTs of ENV-101 treated and placebo patients (ENV-101 = 16; placebo = 18). Key Results from the Post Hoc Analysis Presented at ATS 2025 Significant increase in lung volume (Lung8) for patients in the ENV-101 treatment arm vs placebo (placebo: −113.07 mL vs ENV-101: 142.28 mL; p=0.014; effect size=0.87). Trend towards reduced fibrosis (Fibr8) for ENV-101 treated patients vs placebo (placebo: 1.32pp vs ENV-101: −1.32pp; p=0.063; effect size=−0.64). Significant reduction in normalized pulmonary vessel volume (Vascul8) for patients in the ENV-101 treatment arm vs placebo (placebo: 0.07pp vs ENV-101: -0.25pp; p=0.0007; effect size=-1.28). 'We are excited to share significant findings from the post hoc analysis of the phase 2a clinical trial of ENV-101, highlighting our pulmonary vessel volume quantification model, Vascul8,' said Simon Walsh, M.D., Ph.D., Chief Scientific Officer, Qureight. 'Using this model, we quantified a significant treatment effect from ENV-101, with a greater effect size than forced vital capacity. Qureight's deep learning-based imaging biomarkers offer distinct advantages by capturing treatment signals from each prognostic compartment of the lung separately, optimizing for precision medicine.' About the ENV-101 Phase 2a Clinical Trial Data from the post hoc analysis independently validates and builds upon the previously reported results from the Phase 2a randomized, double-blind, multi-center, placebo-controlled clinical trial of ENV-101 (NCT04968574). In the trial, ENV-101 demonstrated significant improvements in lung function and total lung volume, while also showing a reduction in key measures of lung fibrosis versus placebo with a manageable safety profile. About the WHISTLE-PF Trial Endeavor continues to study ENV-101 and has initiated the Phase 2b WHISTLE-PF (W ound-remodeling H edgehog-Inhibitor I LD S tudy T esting L ung Function E ndpoints- PF) clinical trial, a global, randomized, placebo-controlled study evaluating the therapeutic potential of ENV-101 in individuals with IPF (NCT06422884). The WHISTLE-PF trial will evaluate the efficacy of a range of ENV-101 doses through 24 weeks of treatment, characterize the investigational compound's safety, assess its effect on patient reported outcomes and its effects on lung capacity and lung fibrosis as measured by chest HRCT. About Idiopathic Pulmonary Fibrosis IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis. About ENV-101 Endeavor BioMedicines' investigational medicine ENV-101 (taladegib) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, ENV-101 stops the abnormal accumulation of the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function. About Endeavor BioMedicines Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor's lead candidate, ENV-101 (taladegib), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company's second candidate, ENV-501, is a HER3 antibody-drug conjugate (ADC) in development for the treatment of HER3-positive solid tumors. More information is available at and on LinkedIn or X.
Yahoo
13-05-2025
- Business
- Yahoo
Rein Therapeutics begins trial for idiopathic pulmonary fibrosis treatment
Rein Therapeutics has initiated the randomised RENEW Phase II trial of its Caveolin-1-related peptide, LTI-03, targeting idiopathic pulmonary fibrosis (IPF), with subject screening and recruitment now underway. The double-blind, placebo-controlled, multi-centre trial is designed to assess the tolerability, efficacy and safety of LTI-03 in IPF patients. Additionally, it will evaluate the inhaled dry powder LTI-03 activity across various biomarkers and measure lung function, and the potential for regeneration of healthy tissue. It aims to enrol nearly 120 subjects who have been diagnosed with this condition within five years of screening. These subjects may also be receiving standard-of-care antifibrotic treatment. The study will span up to 50 sites worldwide, including Germany, the US, Austria, Poland, and the UK. Rein noted that subjects in the trial will be randomised into two blinded placebo-controlled cohorts. In the low dose cohort, subjects will be given 2.5mg of either the therapy or placebo, administered two-times daily for a total daily dose of 5mg. The high-dose cohort will be given 5mg twice a day, totalling 10mg per day. Rein Therapeutics president and CEO Brian Windsor said: "Following productive FDA interactions and positive topline results from the Phase Ib trial, we have designed our RENEW trial to test the promise of our dual mechanism approach to targeting alveolar epithelial cell survival and the inhibition of profibrotic signalling in this patient population.' The incidence of treatment-emergent adverse events from day one through week 24 is the primary endpoint of the trial. The key secondary endpoint is the efficacy of the therapy, which will be measured via percent predicted FVC, forced vital capacity and computer tomography, in partnership with Qureight. Subjects will undergo a screening period for 28 days before randomisation and a 24-week treatment duration, with a follow-up period of four weeks. Previously, the company reported positive top-line outcomes from cohort two of the Phase Ib trial of the therapy in IPF, where a positive trend was identified in seven out of eight biomarkers assessed. Five biomarkers showed dose-dependent effects, and four met statistical significance when combining data from cohorts one and two. "Rein Therapeutics begins trial for idiopathic pulmonary fibrosis treatment" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Business
- Yahoo
CUMBERLAND PHARMACEUTICALS PARTNERS WITH QUREIGHT TO ADVANCE INNOVATIVE IDIOPATHIC PULMONARY FIBROSIS TREATMENT RESEARCH
Cumberland leveraging Qureight's deep-learning AI platform for its Phase II FIGHTING FIBROSIS™ clinical trial NASHVILLE, Tenn. and CAMBRIDGE, England, May 13, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced a partnership with Qureight, a Core Imaging Laboratory developing deep-learning image analytics, to enhance the outcome and output of data from Cumberland's FIGHTING FIBROSIS™ clinical trial. The Phase II study is evaluating Cumberland's ifetroban product candidate in patients with idiopathic pulmonary fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease. This collaboration aims to address a critical unmet need for the estimated 2 million IPF patients worldwide, who currently have limited treatment options that can effectively halt disease progression. The partnership will utilize Qureight's advanced, deep-learning image analytics tools for complex lung disease applications to provide deeper insights into treatment efficacy and disease progression in Cumberland's IPF clinical program. Under this partnership, Qureight's AI-driven analytics technologies will be used to quantify changes in multiple imaging biomarkers, using computed tomography (CT) data from FIGHTING FIBROSIS™ study patients. Qureight's quantitative deep learning-based tools will precisely measure changes in the volume of patients' fibrotic, vascular and airway lung compartments, allowing a more detailed investigation of ifetroban's modulation of both lung structure and function. The collaboration leverages Qureight's expertise in IPF and quantitative imaging biomarkers to support Cumberland's evaluation of crucial primary and secondary study endpoints. "We are excited to partner with Qureight as we work to develop a new treatment for patients with IPF – and address that critical unmet medical need," said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "Given ifetroban's promising data demonstrating prevention of lung fibrosis in multiple preclinical models, we believe Qureight's advanced imaging analysis capabilities will provide crucial insights that could help advance understanding and outputs from our IPF clinical program." Cumberland's FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study investigating the safety and efficacy of once daily oral ifetroban for 52 weeks in patients with IPF. The study includes both patients on existing antifibrotic therapies and those not currently receiving such treatments, with a primary endpoint focusing on change in forced vital capacity. "We are thrilled to partner with Cumberland Pharmaceuticals on this important clinical trial," said Dr. Muhunthan Thillai, Chief Executive Officer at Qureight. "Their innovative approach in treating IPF patients for 12 months at this development stage, allows for a truly meaningful assessment of ifetroban's efficacy and tolerability – the characteristics of treatment that IPF patients so urgently need. When combined with our AI image analytics technologies, the resulting data has the potential to significantly deepen our understanding of how to quantify treatment effects in this complex and devastating disease." "The application of AI-driven quantitative imaging in IPF clinical research marks a significant step forward in how we evaluate treatment response," said Phil Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton Hospital, London. "By enabling precise measurement of changes in fibrotic, vascular and airway compartments of the lung, this approach offers insights beyond what traditional pulmonary function tests can provide—potentially allowing us to accelerate the development of urgently needed therapies for patients with IPF." Both Cumberland and Qureight will be attending the upcoming American Thoracic Society International Conference in San Francisco, where the FIGHTING FIBROSIS™ study will be featured in the Clinical Trial Awareness area. This collaborative presence at one of the world's premier respiratory medicine gatherings underscores the companies' shared commitment to advancing innovative solutions for patients with pulmonary fibrosis. About Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by inflammation and fibrosis of the lungs, resulting in rapidly declining lung function and reduced survival within five years of diagnosis. IPF is the most common form of interstitial lung disease and affects up to 2 million individuals globally. While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies. About The FIGHTING FIBROSIS™ Clinical TrialThe FIGHTING FIBROSIS™ clinical trial is a double-blind, placebo-controlled Phase II study designed to evaluate 12 months of oral ifetroban and enroll 128 patients in over 20 medical centers of excellence across the U.S. The study is currently actively enrolling at 16 centers. The clinical trial is registered on under identifier NCT05571059. For more information about the study, including eligibility criteria and participating sites, please visit or contact Ingrid Anderson, PhD at ianderson@ or 615-556-7188. About IfetrobanIfetroban is a potent and selective thromboxane-prostanoid receptor (TPr) antagonist. Ifetroban exhibits high affinity for TPr on many cell types including platelets, vascular and airway smooth muscle, and fibroblasts, and lacks agonistic activity. Ifetroban also displays anti-platelet, antivasospastic, antifibrotic, and antibronchospastic activities and is effective in certain preclinical models of vasospasm, thrombosis, reperfusion injury, cardiac fibrosis, lung fibrosis and endothelial dysfunction, including models that are insensitive to aspirin. Cumberland acquired the ifetroban program in collaboration with Vanderbilt University and Cumberland Emerging Technologies (CET). Cumberland is also sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, and has a Phase II clinical program for Systemic Sclerosis. About Cumberland PharmaceuticalsCumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website: About QureightFounded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory, a rapidly-scaling techbio company deploying its technology on a global scale. The cloud-based, vendor-agnostic Core Imaging Platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a pulmonologist who trained in lung fibrosis. Forward-Looking StatementsThis press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. View original content to download multimedia: SOURCE Cumberland Pharmaceuticals Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
