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.
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Navigators Stockholders Approve Merger with The Hartford16.11.2018 22:01 | Pressemelding
STAMFORD, Conn., Nov. 16, 2018 (GLOBE NEWSWIRE) -- The Navigators Group, Inc. (NASDAQ:NAVG) (“Navigators”) announced that, at a special meeting of stockholders held today, Navigators’ stockholders approved the adoption of the previously announced merger agreement relating to the proposed transaction between Navigators and The Hartford Financial Services Group, Inc. (“The Hartford”), whereby Navigators will become a wholly owned subsidiary of The Hartford. Subject to the terms and conditions of the merger agreement, at the effective time of the merger, each eligible share of Navigators common stock will be cancelled and converted into the right to receive $70.00 in cash. The merger remains subject to various closing conditions, including receipt of various regulatory approvals, and is expected to close during the first half of 2019. About Navigators The Navigators Group, Inc. (NASDAQ: NAVG)(“Navigators” or the “Company”) is a global specialty insurance holding company. We provide custom
This is a test from GlobeNewswire16.11.2018 20:57 | Pressemelding
LONDON, Nov. 16, 2018 (GLOBE NEWSWIRE) -- This is a test from GlobeNewswire. Readers are advised to disregard. TESTING -- TESTING -- TESTING -- TESTING -- TESTING -- TESTING -- TESTING -- TESTING -END- CONTACT: Karen Yu Senior Director, Global Head of GlobeNewswire Media Relations Direct: +1 310 258 6917 Mobile: +1 626 389 7427 or David Didier Lislet Manager, GlobeNewswire Media Relations, EMEA Phone: +33 185 341 347
BlissCo Receives Cannabis Sales License from Health Canada16.11.2018 14:00 | Pressemelding
Not for distribution in the U.S. or to U.S. Newswires VANCOUVER, British Columbia, Nov. 16, 2018 (GLOBE NEWSWIRE) -- via NetworkWire – BlissCo Cannabis Corp. (CSE: BLIS) (OTCQB: HSTRF) (FRA: GQ4B) (“BlissCo” or the “Company”), is pleased to announce that it has received a comprehensive sales license from Health Canada to sell bulk cannabis and pre-packaged, labeled, and tested cannabis products. “We are thrilled to receive our sales license and to be able to start pre-registering clients and supplying both the robust medical and adult-use markets in Canada with our premium cannabis products,” said Damian Kettlewell, CEO of BlissCo. “BlissCo is committed to providing top-tier service to all of our customers.” The Company will soon be launching its e-commerce website and BlissConnect, a telemedicine app for medical cannabis consultations, to service its medical clients. The Company is currently ready to pre-register clients wishing to be first in line when shipping begins. To pre-registe
Gratomic Announces Non-Brokered Private Placement16.11.2018 14:00 | Pressemelding
TORONTO, Nov. 16, 2018 (GLOBE NEWSWIRE) -- Gratomic Inc. (“GRAT” or the “Company”) (TSX-V: GRAT) (FRANKFURT:CB81, WKN:A143MR) is pleased to announce the offering of a non-brokered private placement of up to 10,000,000 working capital units (the “WC Unit”) for up to $1,000,000 (the “Offering”). Each WC Unit is priced at $0.10 and consists of one (1) common share and one (1) common share purchase warrant (“WC Warrant”). Each WC Warrant entitles the holder to purchase one (1) common share (a “WC Warrant Share”) at a price of $0.20 per WC Warrant Share until the earlier of: (i) three (3) years following the Closing of the Offering; and (ii) in the event that the closing price of the Common Shares on the TSX Venture Exchange is at least $0.30 for ten (10) consecutive trading days, and the 10th trading day (the “Final Trading Day”) is at least four (4) months from the Closing Date, the date which is thirty (30) days from the Final Trading Day. Eligible Finders may receive 5% of the value of
Mitratech Listed Among Financial Times’ Inaugural Top 35 Intelligent Business Award Winners and Other Prestigious Categories16.11.2018 10:00 | Pressemelding
Legal Tech Top 10 FTIL Intelligent Business Award for Contracting FTIL Intelligent Business Award for Use of Legal Technology AUSTIN, Texas, Nov. 16, 2018 (GLOBE NEWSWIRE) -- The Financial Times’ inaugural FT Intelligent Business Special Report has recognized Mitratech among the top companies with the greatest impact on the practice and business of law. The report highlights the integration of people, processes, and data to solve a legal business’ operational challenges and how the ramifications of this back-office revolution are felt across organizations everywhere. “The fact that the Financial Times is now tracking the impact of legal technology reinforces that the industry is at a tipping point,” said Jason Parkman, Mitratech CEO. “There’s more transformation that lies ahead. We are honored and humbled to be a part of that movement and in good company with several clients we were recognized with.” The company was presented with the following honors: FT Intelligent Business Top 35: M
GridGain Ranked 77th Fastest Growing Company in North America on Deloitte’s 2018 Technology Fast 500™16.11.2018 09:00 | Pressemelding
1,724 Percent Growth Over the Past Four Years Ranks 19th in the San Francisco Bay Area FOSTER CITY, Calif., Nov. 16, 2018 (GLOBE NEWSWIRE) -- GridGain® Systems, provider of enterprise-grade in-memory computing solutions based on Apache® Ignite™, is ranked No. 77 on the Deloitte 2018 Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America. GridGain, which grew 1,724 percent over the past four years, was the 19th fastest growing company in the San Francisco Bay Area. “GridGain continues to benefit from strong market demand for our market-leading in-memory computing platform that helps customers realize their digital transformation and omnichannel customer experience initiatives,” said Abe Kleinfeld, President and CEO of GridGain Systems. “When you combine the best talent in the industry with great execution and strong customer demand, wonderful things happen.” “Congratulations to the Deloit
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom