Novexatin

Randomized embedded multi-factorial platform trial to provide accelerated, real-world evidence in community acquired pneumonias including COVID-19, influenzas and bacterial pneumonias ABERDEEN, Scotland, June 21, 2021 /PRNewswire/ -- NovaBiotics Ltd, a privately held clinical stage company developing novel immune based therapies for life-threatening and life-limiting-diseases, announces that the Company's proprietary intravenous (IV) cysteamine bitartrate (NM002) therapy candidate is included in a global Phase 3 clinical trial being conducted and funded as part of REMAP-CAP (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community Acquired Pneumonia). REMAP-CAP is a global network of expert clinicians, medical institutions, and research facilities with the objective of evaluating treatments with the potential to reduce mortality, intensive care use, and morbidity in severely ill patients with community acquired pneumonia (CAP). This international, adaptive trial is evaluating multiple treatment options simultaneously at more than 300 clinical sites across more than 20 countries worldwide. The study is funded by a consortium of government funding agencies from participating countries, including the United Kingdom's (UK) National Institute for Health Research (NIHR). NovaBiotics has provided NM002 doses for the initial UK phase of REMAP-CAP and has developed a scalable manufacturing process for NM002 to supply the balance of the trial. NM002 is an immunomodulator-antimicrobial (antiviral and antibacterial) and NovaBiotics' data suggest that its multi-active properties could provide significant benefit in the treatment of CAP. The active pharmaceutical ingredient of NM002, cysteamine, is an endogenous innate immune effector with an underappreciated role in the treatment of the inflammatory consequences of infection. Deborah O'Neil, OBE, PhD, FRSE, Chief Executive Officer of NovaBiotics, commented: "We are delighted that NM002 will be included as part of this important global clinical trial. Inclusion as a Phase 3 intervention is key for NovaBiotics as it gives us a second late-stage clinical product and it brings us one step closer to bringing our potentially life-saving, immunology-based treatment to patients suffering with CAP, including CAP caused by COVID-19 and difficult to treat, even drug resistant bacteria." "This study can provide real-world clinical evidence in a range of CAPs potentially in thousands of patients across several continents. Our ambition is for REMAP-CAP to serve as a registration study for NM002 in a number of key territories in CAP, an important cause of mortality and morbidity worldwide," added Dr. O'Neil. Professor Anthony Gordon, MD, FRCA, FFICM, Chair in Anaesthesia and Critical Care at Imperial College London and the UK Chief Investigator in REMAP-CAP, said: "REMAP-CAP was designed to be an on-going platform to develop effective treatments for severely ill patients with pneumonia. We are, therefore, thrilled to establish collaborations with new partners, such as NovaBiotics, to ensure a growing pipeline of new treatments designed to improve outcomes for some of the sickest patients in hospital." About NIHR The National Institute for Health Research (NIHR) is the United Kingdom's largest funder of health and care research. The NIHR: Funds, supports and delivers high quality research that benefits the NHS, public health and social care; Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research; Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future; Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services; and Partners with other public funders, charities and industry to maximise the value of research to patients and the economy. The NIHR was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK government. About NovaBiotics NovaBiotics Ltd is a privately held, clinical-stage biotechnology company focused on the design and development of novel therapies from two proprietary immunology platforms to address life threatening and life limiting diseases caused by bacteria and fungi and inflammatory-infectious respiratory conditions including cystic fibrosis and community acquired pneumonia (including COVID-19 pneumonia). A leading innovator bringing immunology to the anti-infectives space, the Company's robust technology and business model has been validated through successful development from concept through to the late-stage clinical development of its most advanced product candidates. In addition to the lead NM002 programme and the Company's other late-stage assets (NM001 for cystic fibrosis, NP213/Novexatin® for onychomycosis), NovaBiotics has generated a robust pipeline of earlier stage, high-value drug candidates including NP339 (Department of Health and Social Care funded programme) for life-threatening, drug-resistant invasive and respiratory fungal disease and NP432 for multi-drug resistant bacterial infections. For further information please contact: NovaBiotics: Dr. Deborah O'Neil Chief Executive Officer Telephone: 0044 (0)1224 711377 Email: deborah@novabiotics.co.uk Anne Marie Fields Managing Director Rx Communications Group Email: afields@rxir.com View original content: SOURCE NovaBiotics Ltd

Recently added to the BioPortfolio report store, Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015 is a new report from Global Markets Direct published on 2015-07-30. This 68-page report is available in PDF from $2000. Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015 Summary Global Markets Direct’s, ‘Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015’, provides an overview of the Onychomycosis (Tinea Unguium)’s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Onychomycosis (Tinea Unguium), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Onychomycosis (Tinea Unguium) and special features on late-stage and discontinued projects. Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of Onychomycosis (Tinea Unguium) - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Onychomycosis (Tinea Unguium) and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Onychomycosis (Tinea Unguium) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Onychomycosis (Tinea Unguium) pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage … Table of Contents Table of Contents 2 List of Tables 5 List of Figures 6 Introduction 7 Global Markets Direct Report Coverage 7 Onychomycosis (Tinea Unguium) Overview 8 Therapeutics Development 9 Pipeline Products for Onychomycosis (Tinea Unguium) - Overview 9 Pipeline Products for Onychomycosis (Tinea Unguium) - Comparative Analysis 10 Onychomycosis (Tinea Unguium) - Therapeutics under Development by Companies 11 Onychomycosis (Tinea Unguium) - Pipeline Products Glance 12 Clinical Stage Products 12 Early Stage Products 13 Unknown Stage Products 14 Onychomycosis (Tinea Unguium) - Products under Development by Companies 15 Onychomycosis (Tinea Unguium) - Companies Involved in Therapeutics Development 16 Anacor Pharmaceuticals, Inc. 16 Eisai Co., Ltd. 17 Helix BioMedix, Inc. 18 Hexima Limited 19 Meiji Seika Pharma Co., Ltd. 20 Moberg Pharma AB 21 NAL Pharmaceuticals Ltd. 22 Nihon Nohyaku Co., Ltd. 23 Novabiotics Limited 24 Nuvo Research Inc. 25 Viamet Pharmaceuticals, Inc. 26 Onychomycosis (Tinea Unguium) - Therapeutics Assessment 27 Assessment by Monotherapy Products 27 Assessment by Target 28 Assessment by Mechanism of Action 30 Assessment by Route of Administration 32 Assessment by Molecule Type 34 Drug Profiles 36 AN-2718 - Drug Profile 36 Product Description 36 Mechanism of Action 36 R&D Progress 36 E-1224 - Drug Profile 37 Product Description 37 Mechanism of Action 37 R&D Progress 37 ELS-160 - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 HB-1275 - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 HXP-124 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 luliconazole - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 ME-1111 - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 NAL-3216 - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 NP-213 - Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 terbinafine - Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 terbinafine - Drug Profile 50 Product Description 50 Mechanism of Action 50 R&D Progress 50 VT-1161 - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 Onychomycosis (Tinea Unguium) - Recent Pipeline Updates 53 Onychomycosis (Tinea Unguium) - Dormant Projects 58 Onychomycosis (Tinea Unguium) - Discontinued Products 61 Onychomycosis (Tinea Unguium) - Product Development Milestones 62 Featured News & Press Releases 62 Mar 26, 2015: Moberg Pharma Announces Grant of EU Patent for MOB-015 Related to Topical… For more information open Onychomycosis (Tinea Unguium) - Pipeline Review, H2 2015. 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