PAI-1

Bridge to join as an industry member to advance the science of early detection and speed development of novel treatments SEONGNAM, South Korea and CAMBRIDGE, Mass., July 11, 2023 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotech company developing novel drugs for fibrosis, cancer and inflammation, announced that it has joined PROLIFIC, the Prognostic Lung Fibrosis Consortium, an organization devoted to boosting scientific exploration and drug development in pulmonary fibrosis. PROLIFIC is a non-profit consortium of top-tier research institutions, academic medical centers, and pharmaceutical and biotech companies that are committed to developing treatments for pulmonary fibrosis. Members of PROLIFIC collaborate with each other to share expertise, technology, and data to develop precise and personalized treatments for patients with the fatal and progressive lung diseases. The near-term goal of PROLIFIC is to develop and validate tests for biomarkers indicative of pulmonary fibrosis in patients and to assess the biomarkers in predicting disease worsening or as suitable endpoints for clinical trials. "We are excited to join PROLIFIC and collaborate with other leaders in precision medicine to advance the understanding of pulmonary fibrosis and advance the science of biomarkers to detect this devastating disease," said Sujin Jung, Vice President of Clinical Development and Operations of Bridge Biotherapeutics. "As a member of PROLIFIC, we will be able to tap into a diverse range of expertise, technology, and data that will enable us to accelerate detection of pulmonary fibrosis, and speed the entire industry's development of new treatments." The group of industry members at PROLIFIC has selected 12 biomarkers based on peer-reviewed scientific reports showing their ability to predict the presence of the disease itself, and their potential ability to predict how well a drug candidate may work. The 12 biomarkers being studied include indicators of epithelial damage (CYFRA 21-1, SP-D, CA-19-9, KL-6), fibrosis (MMP-7, Tenascin C, periostin), inflammation (CCL18, CXCL13, slCAM1), and thrombosis (PAI-1). Having a validated panel of biomarkers could enable early detection of treatment response and comparison of drugs across clinical trials, which could speed regulatory approval. PROLIFIC also intends to partner with public health authorities worldwide to achieve the long-term goal of finding biomarkers that can predict which patients would benefit most from a particular treatment, bringing a precision medicine approach to the treatment of this chronic, often fatal condition. The consortium hopes to enable physicians to better tailor therapeutic treatments for patients. By joining PROLIFIC, Bridge Biotherapeutics will be able to collaborate with other pioneering companies in the area of pulmonary fibrosis. In addition to industry-wide advances, Bridge Biotherapeutics hopes to speed development of proprietary idiopathic pulmonary fibrosis pipeline and accelerate development of novel treatments for patients. Bridge Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for areas of high unmet medical needs. The company has three drugs in clinical trials for the treatment of fibrotic diseases such as idiopathic pulmonary fibrosis, as well as inflammatory diseases and cancers, and a robust pipeline of drug candidates in preclinical development. About PROLIFIC PROLIFIC, founded in 2020 by the Pulmonary Fibrosis Foundation and Bristol Myers Squibb, is a consortium of top-tier research institutions, academic medical centers, and biopharmaceutical companies that are committed to advancing precision medicine. The consortium aims to develop well-qualified assays to detect important peripheral blood protein biomarkers in patients with pulmonary fibrosis. Members of PROLIFIC collaborate to share expertise, technology, and data to develop more precise and personalized treatments for patients with devastating and progressive lung diseases. Industry members of PROLIFIC include BMS, Chiesi, Galapagos, Galecto, Genentech, Gilead, Lassen Therapeutics, Lung Therapeutics, NeRRe Therapeutics, Novartis, OptiKira, Pliant Therapeutics, Pulmonary Fibrosis Foundation, Three Lakes Foundation, Tvardi Therapeutics. About Bridge Biotherapeutics, Inc. Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S., is a publicly-traded, clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs, including ulcerative colitis, fibrotic diseases, and cancers. The company is developing BBT-401, a first-in-class Pellino-1 inhibitor for the treatment of ulcerative colitis, BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), BBT-176 and BBT-207, potent targeted cancer therapies for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at . SOURCE Bridge Biotherapeutics, Inc.

Late-breaking oral and poster presentations include clinical and preclinical data related to GULLIVER-2 clinical trialGalecto to host a webinar at 8:00 a.m. ET on Tuesday, November 8, 2022 to discuss expanded topline data and analysis BOSTON, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and a world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced it will present data from its recently completed Phase 1b/2a GULLIVER-2 trial at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2022 being held in Washington, D.C. on November 4-8, 2022. GULLIVER-2 is a clinical trial designed to assess GB1211, an orally available and high-affinity small molecule carbohydrate-based galectin-3 inhibitor, for the treatment of severe liver diseases. Galectin-3 is a pro-fibrotic β-galactoside binding protein highly expressed in fibrotic livers and implicated in severe liver diseases. In a late-breaking oral presentation, which was selected as Best of the Liver Meeting in the NASH/NAFLD category, Galecto will present topline data from Part 2 of its GULLIVER-2 trial (NCT05009680), an innovative, hybrid-design 3-part study investigating the safety, pharmacokinetics (PK), and exploratory efficacy of GB1211 in patients with decompensated cirrhosis. In this study, GB1211 was well-tolerated, had a predictable PK profile and showed encouraging signs of clinical efficacy (liver laboratory tests and FibroScan®). The observed reductions of liver enzyme values and measurements of liver fat indicate a decrease of liver inflammation and underlying steatosis, respectively. Overall, the data suggests a positive therapeutic effect in severe cirrhosis. This trial offers strong support for further development of GB1211 in severe liver diseases. Additional information and further analysis of these data relating to the GULLIVER-2 Part 2 trial findings will also be discussed in a webinar hosted by Galecto on Monday, November 8th at 8 a.m. ET. In a separate poster presentation, Galecto will highlight findings from Parts 1 and 3 of the GULLIVER-2 trial, where preliminary data indicates that liver impairment had moderate effects on the GB1211 PK profile compared to healthy participants. In patients with decompensated cirrhosis, GB1211 was observed to be well-tolerated with no treatment-related adverse events, supporting that it can be orally administered to patients with moderate and severe liver impairment in future trials. In support of the clinical data to be presented at The Liver Meeting 2022, Galecto will also present a late-breaking preclinical poster demonstrating GB1211’s ability to inhibit galectin-3 in severe liver diseases. In this study, the efficacy of GB1211 was investigated in a high fat diet rabbit model of non-alcoholic steatohepatitis (NASH)/fibrosis. GB1211 significantly reduced all measures of inflammation, fibrosis and fat compared to the control group. There were also trends for reduction in fibrotic and galectin-3 mechanistic genes (COL1A1, COL3A1, SNAI2, LGALS3, PAI-1), indicating positive effects of galectin-3 inhibition. “With no approved disease-modifying treatments for decompensated cirrhosis, overall survival rates are poor with a median survival of approximately two years,” said Bertil Lindmark, M.D., Ph.D., Galecto’s Chief Medical Officer. “There is a critical need for new treatment options for severe liver diseases and related complications, including liver cancer. Our presentations at The Liver Meeting demonstrate GB1211’s potential to provide hope to patients living with severe liver diseases.” Presentation Details: Oral Presentation Title: Preliminary safety, pharmacokinetics, and efficacy of GB1211 in cirrhotic patients: initial findings from the GULLIVER-2 trial with focus on the randomized, placebo controlled, 12-week part 2Abstract Number: 5014Publication Number: 39068Date: Tuesday, November 8, 2022Time: 10:30 a.m. ETLocation: Poster Hall Poster Presentation Title: The novel GALECTIN-3 inhibitor GB1211 reduces inflammation & fibrosis in a rabbit high fat diet model of NASH & fibrosisAbstract Number: 38895Poster Number: 5042Date: Monday, November 7, 2022Time: 1:00 – 2:00 p.m. ETLocation: Poster Hall Poster Presentation Title: GULLIVER-2 is an innovative, hybrid, hepatic impairment trial of the oral GALECTIN-3 inhibitor GB1211Abstract Number: 3627Poster Number: 3627 Date: Sunday, November 6, 2022Time: 1:00 p.m. ETLocation: Poster Hall The abstracts for each of these presentations may be accessed here. GULLIVER-2 Topline Data Webcast Information: Galecto will host a live conference call and webcast at 8:00 am ET on Tuesday, November 8, 2022. Below please find updated dial-in and webcast information. U.S. Dial-in Number: 1-877-300-8521Int’l Dial-in Number: 1-412-317-6026Conference ID: 10172584Webcast: Click HERE The presentation and poster materials along with a replay of the call will be available on Galecto’s investor relations website at https://ir.galecto.com. About Liver DiseaseLiver diseases, including liver fibrosis or cirrhosis, are a global health burden. Cirrhosis – primarily caused by non-alcoholic steatohepatitis, alcoholic liver disease and hepatitis – is the end stage of progressive liver fibrosis and the leading cause of liver-related death globally. About the GULLIVER-2 TrialThe GULLIVER-2 trial (NCT05009680) is a Phase 1b/2a trial designed to assess the safety, tolerability, pharmacokinetics and potential activity of GB1211 in up to 54 participants. This study includes patients with decompensated cirrhosis (Child-Pugh Classes B and C). The study consists of three separate parts. Parts 1 and 3 of the GULLIVER-2 trial are open-label, single dose study parts designed to evaluate the safety and pharmacokinetics of GB1211 in patients with moderate to severe hepatic impairment (Child-Pugh B and C, respectively) and compare with matched healthy subjects. Part 2 of the GULLIVER-2 trial is a Phase 2, randomized, double-blind, placebo-controlled trial in 30 patients that is designed to assess the effect of 12-week repeated dosing of oral GB1211 in patients with decompensated cirrhosis (Child-Pugh B). Patients are randomized 1:1 to receive oral GB1211 100mg or placebo twice daily for 12 weeks. About GB1211Galecto is developing GB1211, an orally available and potent small molecule galectin-3 inhibitor. Galecto’s initial target indications for GB1211 are liver cirrhosis, a severe, progressive disease that ultimately leads to liver failure, and non-small cell lung cancer, a cancer indication with a high unmet medical need. GB1211 demonstrated antifibrotic activity and anti-cancer effects in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 had a favorable tolerability profile and exhibited dose-dependent pharmacokinetics. About GalectoGalecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has four ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2 trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a Phase 1b/2a trial in liver cirrhosis; and (iv) an orally active galectin-3 inhibitor (GB1211) in a separate Phase 2 trial for the treatment of non-small cell lung cancer (NSCLC) in combination with atezolizumab (Tecentriq®). Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking StatementsCertain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the tolerability and efficacy of GB1211, that the GULLIVER-2 trial will provide a holistic view of the safety, pharmacokinetics, liver function and liver-related parameters of GB1211, as well as Galecto’s general focus, plans for clinical development, product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto’s Annual Report on Form 10-K, as filed with the SEC on February 17, 2022. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law. For more information, contact: Galecto, Inc.Hans Schambye, CEOJon Freve, CFO+45 70 70 52 10 Investors/USAshley R. Robinsonarr@lifesciadvisors.com +1 617 430 7577 Media/EUSandya von der Weidsvonderweid@lifesciadvisors.com+41 78 680 053

WALTHAM, Mass., Oct. 20, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced three posters will be presented at the American Society of Nephrology (ASN) Kidney Week 2022 to be held November 3-6, 2022, in Orlando, Florida. XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Three poster presentations highlight data from three Phase 3 trials (BLOCK, AMPLIFY and PHREEDOM) in patients with hyperphosphatemia on maintenance dialysis in the U.S. Additionally, the company's collaboration partner for tenapanor in Japan, Kyowa Kirin Co., Ltd. (Kyowa Kirin), will present key results from two Phase 3 studies of tenapanor in a similar patient population in Japan. Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found at . In addition to the poster presentations during ASN, Ardelyx is sponsoring an Exhibitor Spotlight titled: The Phosphorus Management Puzzle and Need for New Pieces: the Patient and Physician Perspective, on Saturday November 5, 2022, from 12:30-1:15pm ET. During this Exhibitor Spotlight, Dr. Geoff Block, MD, associate chief medical director and senior vice president of clinical research and medical affairs at U.S. Renal Care and Dawn P. Edwards, patient ambassador, co-chair, national forum of ESRD networks kidney patient advisory council, will review the consequences of hyperphosphatemia, the current understanding of phosphate absorption, and the importance of managing hyperphosphatemia, including current management practices and inherent challenges. Dr. Block is also a member of Ardelyx's board of directors. About XPHOZAH (tenapanor) for Hyperphosphatemia XPHOZAH (tenapanor), discovered and developed by Ardelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI). With its unique blocking mechanism of action, tenapanor acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30 mg tablet BID dosing regimen. The most common side effect with tenapanor in clinical trials was diarrhea. About Hyperphosphatemia Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect more than 745,000 dialysis patients in major developed countries. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5 mg/dL) About Ardelyx, Inc. Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx's first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories. SOURCE Ardelyx