FibroGen, Inc.

The emerging therapies for the treatment of idiopathic pulmonary fibrosis include a great deal of emerging drugs Tyvaso (treprostinil), BI 1015550, and others. The emerging therapies in the pipeline have the potential to change the IPF market size and manage the disease burden and progression. LAS VEGAS, Sept. 9, 2024 /PRNewswire/ -- Idiopathic pulmonary fibrosis (IPF) is when the lungs become scarred, and breathing becomes increasingly difficult. Damage to the alveolar epithelium and abnormal wound repair are theorized to be key factors in the development of this disease. Although the cause of IPF is unknown, researchers postulate that the disease probably results from genetic and environmental factors. There is a strong possibility that genetic changes increase a person's risk of developing IPF and subsequent exposure to certain environmental factors that further trigger the disease. However, much is still unknown about this emerging field of study. As per DelveInsight analysis, the total diagnosed prevalent cases of IPF in the 7MM was 193K cases in 2023 which are expected to rise, at a significant CAGR during the study period (2020–2034). The therapeutic approach of IPF involves both nonpharmacological and pharmacological strategies. The goal of the treatment is to slow disease progression, reduce symptoms, prevent acute exacerbations, and prolong survival. Currently, two drugs, OFEV (nintedanib) and ESBRIET (pirfenidone), are approved for treating IPF. These drugs are classified as anti-fibrotic agents, which clinical trials have shown to slow down lung fibrosis or scarring. Pirfenidone is a modified pyridine small molecule with anti-fibrotic, anti-inflammatory, and antioxidant properties. Learn more about the FDA-approved IPF drugs @ Drugs for Idiopathic Pulmonary Fibrosis Treatment Pirfenidone reduces the likelihood of respiratory-related hospitalization over a year of treatment. It is generally well-tolerated, with mild side effects such as skin rash, weight loss, nausea, and fatigue. However, there have been instances of abnormal liver function, including elevated serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, necessitating regular liver function monitoring for patients on pirfenidone. Nintedanib is an intracellular tyrosine kinase inhibitor that binds to adenosine triphosphate binding sites, thus inhibiting the signaling pathways associated with vascular endothelial growth factor receptor, fibroblast growth factor receptor 1–3, and platelet-derived growth factor receptor α and β. The main side effects are diarrhea and nausea, which are manageable with medication, but hepatotoxicity can occur in rare cases. Before May 2022, ESBRIET and OFEV were the only approved treatments for IPF available on the market. However, Sandoz Pharmaceutical recently launched a generic version of pirfenidone in the US. This new entry is expected to significantly impact Hoffmann-La Roche's ESBRIET market and disrupt the market for OFEV as well. Over the years, various drugs have been studied for treating IPF. With the ongoing need for more advanced and specific treatment approaches, new therapies beyond conventional methods are being developed for IPF. To know more about IPF treatment options, visit @ New Treatment for Idiopathic Pulmonary Fibrosis Companies across the globe are diligently working toward the development of novel treatment therapies with a considerable amount of success over the years. To date, there are several emerging market players, United Therapeutics, Boehringer Ingelheim, Pliant Therapeutics, Inc., and others that are developing drugs for the treatment of IPF. Discover which therapies are expected to grab major IPF market share @ Idiopathic Pulmonary Fibrosis Market Report Tyvaso (treprostinil), developed by United Therapeutics, is a prostacyclin mimetic approved to treat pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), aiming to enhance exercise capacity. The company is currently conducting a global Phase III clinical trial called TETON 1 to evaluate Tyvaso for the treatment of patients with IPF. BI 1015550, an experimental oral PDE4B inhibitor with both antifibrotic and anti-inflammatory properties, is under development by Boehringer Ingelheim. Recently, the company released encouraging 12-week Phase II data demonstrating a reduction in lung function decline in IPF patients. The drug is now in Phase III of clinical trials. PLN-74809, the leading program from Pliant Therapeutics, is an oral, small-molecule dual selective inhibitor targeting αVβ1 and αVβ6 integrins, under development for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). These integrins are responsible for the upstream activation of TGF-β1 in fibrotic tissues. By inhibiting these integrins, PLN-74809 aims to block TGF-β1 activation, thus preventing the growth of fibrotic tissue in the lungs and bile ducts. The drug is currently in Phase II of clinical development. Fipaxalparant (HZN-825), developed by Horizon Therapeutics/Amgen, is an oral selective lysophosphatidic acid receptor 1 (LPAR-1) antagonist that has demonstrated promising early clinical results in treating systemic sclerosis. The company is now conducting a Phase II pivotal trial to assess HZN-825 for the treatment of IPF. Discover more about drugs for IPF in development @ Idiopathic Pulmonary Fibrosis Clinical Trials The anticipated launch of these emerging therapies for IPF are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IPF market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for IPF is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the increasing prevalent cases over the globe and thus the surge in treatment options. The expected launch of emerging therapies for IPF treatment is expected to boost the market in the forecast period (2023–2034). DelveInsight's latest published market report titled as Idiopathic Pulmonary Fibrosis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the IPF country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The IPF market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Gender-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Age-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis Severity-specific Diagnosed Prevalent Cases of Idiopathic Pulmonary Fibrosis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM IPF market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this IPF market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the IPF market. Also, stay abreast of the mitigating factors to improve your market position in the IPF therapeutic space. Related Reports Idiopathic Pulmonary Fibrosis Pipeline Idiopathic Pulmonary Fibrosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key idiopathic pulmonary fibrosis companies, including FibroGen, United Therapeutics, Bellerophon Therapeutics, MediciNova, Novartis, Endeavor BioMedicines, Pliant Therapeutics, Nitto Denko, Kadmon Pharmaceuticals, Calliditas Therapeutics, Avalyn Pharmaceuticals, PureTech Health, Taiho Pharmaceutical, Bristol-Myers Squibb, Galecto Biotech AB, CSL Behring, Celgene Pharmaceutical, Vicore Pharma, Boehringer Ingelheim, Guangdong Raynovent, Sunshine Lake Pharma co, Suzhou Zelgen Biopharmaceuticals, Algernon Pharmaceuticals, Horizon Therapeutics, Daewoong Pharmaceutical, Metagone Biotech, AstraZeneca, Lung Therapeutics, Bridge Biotherapeutics, AstraZeneca, Kinarus AG, Insmed, Reviva Pharmaceuticals, Annapurna Bio, Guangdong Hengrui Pharmaceutical Co., Ltd, Ark Biosciences, Ocean Biomedical, among others. Cough in Idiopathic Pulmonary Fibrosis Market Cough in Idiopathic Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cough in idiopathic pulmonary fibrosis companies, including NeRRe Therapeutics, Trevi Therapeutics, Algernon Pharmaceuticals, Seyltx Inc., Melius Pharma AB, Cellular Sciences, Emphycorp, among others. Pulmonary Fibrosis Pipeline Pulmonary Fibrosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. Pulmonary Fibrosis Market Pulmonary Fibrosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pulmonary fibrosis companies, including Roche, Boehringer Ingelheim, Galecto Biotech, Cipla, Gilead Sciences, Fibrogen, Bristol-Myers Squibb, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

SAN FRANCISCO, Sept. 03, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Company will be attending and presenting at the H.C. Wainwright 26 th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY. Thane Wettig, Chief Executive Officer of FibroGen, will deliver a company presentation on Tuesday, September 10 at 3:00 PM ET at the Lotte New York Palace Hotel. A live webcast of the presentation will be available here . FibroGen’s management team will be available for one-on-one meetings during the conference. Interested investors should contact their representative at H.C. Wainwright. A replay of the presentation will be posted, when available, to the FibroGen website on the Events & Presentation page of the investors section for 90 days. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit . For Investor Inquiries: David DeLucia, CFA Vice President of Corporate FP&A / Investor Relations ir@fibrogen.com

While the Phase II portion of the study evaluating AN2’s epetraborole met the primary endpoint, it failed in a “key” secondary endpoint prompting trial termination. Image Credit: kora_sun / Shutterstock. AN2 Therapeutics has implemented cost-saving measures after “disappointing” topline results from Phase II part of the Phase II/III trial evaluating its lead antibiotic, epetraborole. The antibiotic’s development suffered a major setback a few months ago after AN2 voluntarily stopped enrolment in the Phase III portion of the trial. The decision followed a blinded aggregate data analysis indicating “potentially lower than expected efficacy”. Following the news, AN2’s stock was down by over 22.7% in premarket trading today (9 August), compared to the market close on 8 August. The company’s stock has been floundering since it took a nosedive in February after AN2 announced plans to pause enrolment in the Phase III portion of the trial. AN2 plans to cut 50% of its workforce by the end of the year. The restructuring is expected to cost approximately $2m – $3m. Furthermore, AN2’s chief medical officer, Dr Paul Eckburg, will leave the company by 30 August as part of the restructuring. The cost savings measures are expected to provide AN2 a cash runway through 2027. With the announcement of job cuts, AN2 joins the likes of FibroGen , Aerovate Therapeutics and Allakos , all of which have reduced their headcounts after trial failures this year. See Also: Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world Epetraborole is a bacterial leucyl-tRNA synthetase inhibitor. AN2 licensed the therapy from Pfizer , who gained it as part of a $5.2bn acquisition of Anacor Pharmaceuticals . AN2 was evaluating epetraborole as a treatment for refractory mycobacterium avium complex (MAC) lung disease. The placebo-controlled Phase II/III trial (NCT05327803) enrolled 80 patients with treatment refractory MAC lung disease. Although the Phase II portion met its primary endpoint of patient-reported response, there was no significant difference between the treatment and placebo arms in a “key” secondary endpoint of sputum culture conversion at six months. Whilst AN2 has shut down the development of epetraborole in MAC lung disease, it plans to start a Phase II trial evaluating the therapy in melioidosis, a bacterial infection. Another therapy in AN2’s pipeline is AN2-502998 for the treatment of Chagas disease , an infectious illness caused by a parasite transmitted by ticks.