4D pharma plc Announces Clinical Update for Blautix Phase II Study
First Patient Enrolment in Blautix IBS Phase II Study
LEEDS, United Kingdom, Nov. 08, 2018 (GLOBE NEWSWIRE) -- 4D pharma plc (AIM: DDDD), (the “Company” or “4D”) a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the randomisation of the first patient in a Phase II clinical trial of Blautix in patients with Irritable Bowel Syndrome (IBS). The study will recruit up to 500 patients at sites across the US and EU and is set to be the largest clinical trial of a Live Biotherapeutic conducted to date.
The double-blind, placebo-controlled multicentre Phase II study will evaluate the efficacy and safety of Blautix in patients with IBS with constipation (IBS-C) and/or IBS with diarrhoea (IBS-D). The Company has consulted with the FDA on the design of the study. Up to 500 patients will receive either Blautix or placebo daily for 8 weeks. The primary endpoint will be the Overall Response rate, defined as the proportion of patients reporting an improvement in their weekly cohort-specific symptoms (abdominal pain and stool frequency or consistency) for at least 4 out of 8 weeks. A range of secondary efficacy endpoints will also be assessed, as well as the effects of Blautix on the gut microbiome.
Dr. Alex Stevenson, 4D’s Chief Scientific Officer, commented: “We are delighted to have enrolled the first patient in this important study, which brings us another step towards making Blautix available for patients. IBS remains an area of significant unmet need, with existing treatments limited to symptom management and many patients struggling to achieve relief. By targeting the gut microbiome, Blautix targets the underlying pathophysiology of IBS and has the potential to fundamentally change the way these patients are treated.”
For further information please contact:
|4D||+44 (0)113 895 0130|
|Duncan Peyton, Chief Executive Officer|
|Zeus Capital Limited - Nomad and Joint Broker||+44 (0) 161 831 1512|
|Dan Bate / Jordan Warburton|
|Bryan Garnier & Co. Limited - Joint Broker||+44 (0)20 7332 2500|
|Dominic Wilson / Phil Walker|
Founded in February 2014, 4D is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacteria, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform that rationally identifies novel bacteria that have a precise and evolved therapeutic effect. All of 4D’s Live Biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. 4D has completed a Phase I study in Irritable Bowel Syndrome and has completed dosing in a Phase I study in Paediatric Crohn’s Disease. It currently has a pipeline of 13 pre-clinical programmes, covering disease areas such as cancer, poorly controlled asthma, autoimmune and CNS disease, and plans to commence four additional clinical studies in 2018.
IBS is a functional bowel disorder characterised by discomfort, pain and changes in bowel habits. Symptoms can be mild, moderate or severe. Mild symptoms, which occur infrequently, can sometimes interfere with normal daily functioning. Moderate symptoms are more intense, occur more frequently, and often interfere with daily functioning. Severe symptoms chronically interfere with daily functioning. It is estimated that 10-15% of the population have IBS, with only 30-35% of subjects seeking medical attention, the majority of which have persistent symptoms. There are currently few approved treatment options, all of which focus on the modulation of symptoms.
Blautix is a single-strain Live Biotherapeutic candidate in development for the treatment of IBS with constipation (IBS-C) and IBS with diarrhoea (IBS-D). The organism was originally isolated from a healthy individual and has a distinctive metabolism which utilises intestinal hydrogen as an energy source, reduces levels of hydrogen sulphide, and increases microbiota diversity and stability. Unlike existing therapies which only seek to address IBS symptoms, by targeting the microbiome Blautix has the potential to act directly on the underlying pathophysiology of disease to treat all IBS patients irrespective of traditional sub-types.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Taconic Biosciences’ Animals Complete Most Recent Mission to the International Space Station17.1.2019 15:29 | Pressemelding
RENSSELAER, N.Y., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces the completion of a recent mission to the International Space Station. This project represents a collaboration between the International Space Station (ISS) National Lab, National Aeronautics and Space Administration (NASA), Bioserve Space Technologies with support from the Leidos Corporation, and Taconic. Taconic has participated in several spaceflight missions with NASA since 1985. Most recently, as part of the science and research investigation payloads supported by the SpaceX Commercial Resupply Services missions, Taconic prepared mice to live aboard the International Space Station for extended periods. Previous spaceflight studies demonstrated that mice undergo rapid loss of muscle and bone mass, resembling accelerated aging. Therefore, mice exposed to microgravity via spaceflight are a valuable model to understand and devel
MPP Global Bridges the Innovation Gap by Centralising Physical and Digital Subscriber Management and Billing in a Single Cloud Platform17.1.2019 12:29 | Pressemelding
WARRINGTON, UK, Jan. 17, 2019 (GLOBE NEWSWIRE) -- MPP Global, the technology company that delivers eSuite, the world’s smartest subscriber management & billing platform, announces the launch of pivotal new functionality which enables media organisations to seamlessly create and manage the sale of physical subscriptions. This positions eSuite as the complete physical and digital subscription management solution. The development of this industry-first functionality was borne out of the common challenge for publishers when managing multiple systems for deploying bundled print and digital subscriptions. This is inflexible for publishers and limits choice for their customers, restricting the ability to seamlessly create and offer digital and print subscription bundles. Despite increased consumer uptake of digital subscriptions, print still accounts for almost 90% of circulation revenues globally. To drive reader revenues successfully, publishers require functionality to execute complementar
Fortuna reports 2018 full year production of 12.8 million silver equivalent ounces and issues 2019 guidance17.1.2019 11:00 | Pressemelding
VANCOUVER, British Columbia, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines, Inc. (NYSE: FSM) (TSX: FVI) is pleased to announce fourth quarter and full year 2018 production figures from its two underground operating mines, the San Jose Mine in Mexico and the Caylloma Mine in Peru. For the full year 2018, the Company produced 8.9 million ounces of silver and 54.2 thousand ounces of gold or 12.8 million Ag Eq1 ounces. 2018 Consolidated Production Highlights Silver and gold production were 7 % and 12 % respectively above 2018 guidance Silver production of 8,890,943 ounces; 5 % increase over 2017 Gold production of 54,210 ounces; 4 % decrease over 2017 Zinc production of 45,484,648 pounds; 3 % increase over 2017 Lead production of 28,254,570 pounds; 5 % decrease over 2017 2018 Consolidated Operating Results Q4 2018 2018 Caylloma, Peru San Jose, Mexico Consolidated Caylloma, Peru San Jose, Mexico Consolidated Processed Ore Tonnes milled 135,034 256,181 534,773 1,040,478 Average tpd
WillScot to Participate at the Barclays Industrial Select Conference16.1.2019 21:00 | Pressemelding
BALTIMORE, Jan. 16, 2019 (GLOBE NEWSWIRE) -- WillScot Corporation (“WillScot”)(NASDAQ: WSC), the specialty rental services market leader providing innovative modular space and portable storage solutions across North America, today announced that Brad Soultz, President and Chief Executive Officer, and Tim Boswell, Chief Financial Officer, will present at the Barclays Industrial Select Conference at the Loews Miami Beach Hotel in Miami, Florida, on Wednesday, Feb. 20, 2019. The presentation will take place at 10:20 a.m. EST. About Williams Scotsman Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the WillScot family of companies in the United States, Canada and Mexico. WillScot Corporation trades on the NASDAQ stock exchange under the ticker symbol “WSC.” WillScot is the specialty rental services market leader providing innovative modular space and portable storage solutions across North America. It is the modular space supplier of choice for t
CCI has been retained by Waterloo Brewing to obtain Cannabis Licence16.1.2019 16:00 | Pressemelding
TORONTO, Jan. 16, 2019 (GLOBE NEWSWIRE) -- Cannabis Compliance Inc., (CCI) of Toronto, Ontario is pleased to announce they have partnered with Waterloo Brewing to help them obtain their Research and standard Processing Licence to develop cannabis-infused beverages. “CCI is working with Waterloo Brewing on the early stages of the application process and we are confident that we will help them achieve their desired licenses in time to be an active player in this growing sector of the cannabis industry”, said Brian Wagner, CEO and Founder, Cannabis Compliance Inc. “We are here to guide our clients through the early stages of the licensing process and for the many Health Canada requirements thereafter.” CCI offers end to end business solutions for cannabis companies large and small. Our team brings with them years of experience in the quality, regulatory, security and cultivation sectors, and supports manufacturers and retailers through regulatory challenges. As the world’s largest and mos
Aryaka Announces Expansion of Senior Leadership Team with New Chief Revenue Officer, Chief Transformation Officer and Chief Marketing Officer16.1.2019 15:00 | Pressemelding
Karen Freitag, Michelle Owczarzak, & Shashi Kiran join Aryaka to address significant growth and assist global enterprises in adopting managed connectivity as-a-service SAN MATEO, Calif., Jan. 16, 2019 (GLOBE NEWSWIRE) -- Aryaka®, announced today the appointment of several new executive hires to the company’s leadership team, including Karen Freitag (Chief Revenue Officer), Michelle Owczarzak (Chief Transformation Officer), and Shashi Kiran (Chief Marketing Officer). “Connectivity is the lifeblood of the global enterprise and Aryaka is the industry benchmark for secure managed connectivity worldwide. We are excited to have experienced industry veterans join our robust executive leadership team and continue to help build upon the immense success and growth that Aryaka has seen in recent years,” said Matt Carter, CEO of Aryaka. “As our customers expand globally, embrace SD-WAN, or move to the cloud, we’re becoming the de facto choice for their needs to make this happen better, faster, che