Motif is developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Motif has a lead antibiotic candidate, iclaprim, and MTF-001, a preclinical program to design a best-in-class dihydrofolate reductase inhibitor (DHFRi). Discussions and negotiations with academic institutes are under way to build a portfolio of antibiotic candidates through licensing. It is anticipated that Motif’s lead antibiotic candidate could be ready for commercialization as early as 2018.

At Motif, members of our team have already developed blockbuster new drugs at the world’s leading pharmaceutical companies and are the named inventors on over 160 U.S.‐issued patents. With our deep drug discovery and development expertise, we have unique proprietary insights to fix flaws of existing first‐in‐class drugs and to design best‐in‐class compounds. We have partnered with leading drug discovery and development companies. Together with a seasoned management team, Motif is positioned to rapidly identify and commercialize novel antibiotics.

Antibiotic resistance has limited the effectiveness of many existing drugs. The discovery of new antibiotics to address this resistance has not kept pace with the increasing incidence of difficult‐to‐treat bacteria. Without new antibiotics effective against resistant bacteria, the risk is that within five to ten years, routine surgeries such as hip and knee replacements, cardiac catheterization, caesarian section, and coronary artery bypass grafts would be impossible without effective antibiotics. One of the biggest threats is from methicillin‐resistant staphylococcus aureus (“MRSA”), a leading cause of hospital‐acquired infections and a growing cause of infections in healthy people. In 2013, the Centers of Disease Control (“CDC”) reported that at least 2M people became infected with bacteria that are resistant to antibiotics and at least 23,000 Americans died as a direct result of these infections – more than the annual number of deaths of people diagnosed with AIDS.

Given the urgent need to find new antibiotics to address this problem, Motif has a dedicated effort in developing new best‐in‐class antibiotics, each targeting different and unique mechanisms of action to be effective against bacteria that are resistant to most currently available antibiotics.


First Day of Dealings: Clinical stage biopharmaceutical company developing new antibiotics admitted to AIM April 2, 2015



http://www.motifbio.com/

proactiveinvestors,-motifbio-and-summit-therapeutics-on-the-warpath-to-beat-drug-resistant-bacteria

Motif Bio to cash in on super-bug drug market, says broker

By Philip Waller

May 27 2015, 12:54pm
Mycobacterium tuberculosis bacteria, which causes TB. Image: US NIAID
Mycobacterium tuberculosis bacteria, which causes TB. Image: US NIAID


Newly-listed antibiotics specialist Motif Bio (LON:MTFB) is well-placed to cash in on concerns about a global health crisis sparked by super-bugs, a broker says.




Motif is developing novel antibiotics such as Iclaprim, which are designed to fight serious and life-threatening infections caused by bacteria resistant to several drugs.




Northland Capital Partners said the world’s line-up of drugs able to overcome stubborn diseases is inadequate, creating an opportunity for Motif and other specialist drug developers.




“Iclaprim is set to fill a major market void,” Northland said in a note.




The World Health Organisation (WHO) has warned that growing resistance to antibiotics of bacteria, parasites, viruses and fungi is an increasingly serious threat to global public health.




Resistance to HIV drugs has gradually increased, boosting fears that more expensive treatments may be needed soon.




There were about 480 000 new cases of multidrug-resistant tuberculosis (MDR-TB) in 2013, which requires much longer and less effective treatment courses than those for non-resistant TB, the WHO said.




“Patients with infections caused by drug-resistant bacteria are generally at increased risk of worse clinical outcomes and death and consume more health-care resources than patients infected with the same non-resistant bacteria,” the WHO said in a paper last month.




Iclaprim could be ready for commercialisation within three years or so, Northland said.




It exploits a relatively under-used technique that makes it less vulnerable to developing anitibiotic resistance.




“Having already been tested on over a thousand patients, Iclaprim’s safety and efficacy is well supported,” Northland said.




Motif listed on AIM last month in a flotation of new shares at a placing price of 20p that raised £2.84mln, representing 22.1% of the enlarged share capital of the group.




Motif plans to use the cash to complete preparations to enter phase III trials with iclaprim and to provide working capital.




Northland has initiated coverage on Motif with a “buy” rating and an 89p price target.




“We believe Motif is grossly undervalued,” the broker said. Shares in Motif rose 2p to 33p in midday trading in London.

Big market here could do well.

FDA Meeting Minutes Confirming Iclaprim Phase III
RNS
RNS Number : 4282O
Motif Bio PLC
28 May 2015

28 May 2015

Motif Bio plc.

("Motif" or the "Company")

Motif Receives FDA Meeting Minutes Confirming Iclaprim Phase III Clinical Development Programme

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received the official meeting minutes from the U.S. Food and Drug Administration (FDA) guidance meeting which was held on 14 April 2015. The minutes confirm the FDA's agreement with Motif's Phase III clinical development programme for iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria.

Iclaprim, a novel selective inhibitor of microbial dihydrofolate reductase (DHFR), is being developed as an intravenous (IV) formulation to treat acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP) caused by Gram positive pathogens, including resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP). The FDA has confirmed that two successful Phase III trials are required for the approval of iclaprim.

Graham Lumsden, CEO of Motif Bio plc, commented:

"This FDA confirmation supports Motif moving forward to begin the iclaprim Phase III clinical programme. The trials will investigate the safety and efficacy of iclaprim in patients with ABSSSI and HABP, two serious and life threatening infections caused by multi‐drug resistant bacteria. We believe that iclaprim may be an important addition in the fight against life threatening infections, a battle that is currently being lost to increasing antimicrobial resistance."

28 May 2015 sp 36p
Can't say I like Bios that think they have the answer to something that's been baffling the World for decades . . . unless they have a "novel" approach which I've not read, writ large.
Also, not keen on small caps with overseas Execs such that they maybe should be listed there . . . . why here?
Good luck for all who . . . .

28 May Northland... 89.00 Buy

Closed up 12%

29 May Beaufort... N/A Speculative Buy
28 May Northland... 89.00 Buy
27 May Northland... 89.00 Buy

RNS out.

Motif partners with Leading Global CRO
RNS
RNS Number : 7104O
Motif Bio PLC
01 June 2015

1 June 2015

Motif Bio Plc

("Motif" or the "Company")

Motif partners with Leading Global CRO for Phase III Clinical Trials with Iclaprim

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that its wholly-owned subsidiary, Motif BioSciences Inc., has signed Letters of Intent (LOIs) and interim agreements with a leading global Clinical Research Organisation (CRO). Under the terms of these interim agreements, the CRO will undertake preparations for two Phase III, randomised, double-blind, multicenter clinical trials to evaluate the efficacy and safety of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections ("ABSSSIs") suspected or confirmed to be due to Gram-positive pathogens.

Iclaprim is a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria. Motif is investing over US$950,000 under the terms of the interim agreements, to be paid by 31 July 2015. Pursuant to the LOIs, the parties will negotiate the terms and conditions of a mutually acceptable formal agreement for the conduct of the two studies.



The selected CRO is one of the world's top five providers of Phase I-IV clinical trial management services and to date, has contributed to the development of all of the top 50 prescription medicines on the market. The CRO has unique insights into infectious disease clinical trials with over 17,000 patients in more than 150 studies.



Graham Lumsden, CEO of Motif Bio plc, commented:

"Retaining this leading global CRO is the first major step for Motif in achieving our goal of successfully completing Phase III clinical trials with iclaprim. The safety and efficacy of this broad spectrum antibiotic has already been proven in many patients, and we believe that iclaprim may be an important treatment option for ABSSSIs. Combining the knowledge and experience of Motif's management and directors with the infectious diseases expertise of our selected CRO is expected to add tremendous value for our investors."

1 Jun Northland... 89.00 Buy

Up 15% today.

A further 22% today

RNS
RNS Number : 5772P
Motif Bio PLC
09 June 2015

9 June 2015

Motif Bio plc



Motif BioSciences, Inc.

Audited non-statutory financial statements for the

year ended 31 December 2014



Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, reports to the market today the non-statutory financial statements of its wholly-owned subsidiary, Motif BioSciences, Inc. for the year ended 31 December 2014 - a period prior to the completion of the Company's merger, acquisition, and admission to AIM.



Since the end of the period covered by these financial statements, Motif Bio plc has completed the Group re-organisation, a necessity of becoming the holding company of the Group. Motif has also converted and restructured its liabilities, acquired the iclaprim assets, and raised new funds of approximately US $4.3 million, before issue costs of approximately US $1.0 million, through a placing and subscription of new shares and seen its shares admitted to trading on AIM.

These financial statements have been published to enable Motif Bio plc to comply with its financial reporting obligations under the AIM Rules and are presented and prepared in a form consistent with the financial information, and on the basis of the accounting policies of Motif BioSciences, Inc. set out in Part IV of the AIM admission document published by Motif Bio plc on 27 March 2015.

POST BALANCE SHEET HIGHLIGHTS:



· A transformational period including completion of the Group's re-organisation, acquisition of iclaprim's assets, US $4.3 million raised in new funds and successful listing on AIM.



· On 15 April 2015, the U.S. Food and Drug Administration (FDA) agreed to the proposed Phase III clinical development programme for iclaprim.



· On 1 June 2015, Motif BioSciences, Inc. signed Letters of Intent and interim agreements with a leading global Clinical Research Organisation - one of the world's top five providers of Phase I-IV clinical trial management services and to date, has contributed to the development of all of the top 50 prescription medicines on the market.



· Motif Bio plc selected to present at the 2015 BIO Equity Conference and at the 2015 BIO International Convention, two leading global partnering and investor events for the Biotechnology sector.



· One of the few opportunities for AIM investors to gain exposure to a late stage clinical asset that already has a wealth of safety and efficacy data from previously completed Phase III trials.



Richard Morgan, Chairman of Motif Bio plc, commented:



"Motif Bio plc has made excellent progress in a short period of time towards the goal of completing the clinical development of iclaprim and bringing this novel antibiotic to market. It is unusual to have a late stage clinical asset that already has a wealth of safety and efficacy data from previously completed Phase III trials, and that now has agreement from the FDA to initiate a new Phase III programme. The scientists at Motif Bio plc have been able to identify a number of ways to improve this new Phase III programme, based on careful analysis of the existing data, the evolving knowledge of infectious diseases, and the improved regulatory environment.



"With new incentives from governments, including the GAIN Act in the US, broad recognition by politicians and regulators of the need to help speed the development of novel antibiotics, and the unique properties of iclaprim, Motif Bio plc is well placed to make an important contribution in response to the challenges of anti-microbial resistance and the need for novel antibiotics."

9 Jun Northland... 89.00 Buy

10 Jun Beaufort... 110.00 Speculative Buy

On Wednesday, Motif Bio PLC (MTFB:LSE) closed at 70.00, 8.9 % below its 52-week high of 76.83, set on Jun 04, 2015.

24 Jun Beaufort... 110.00 Speculative Buy

New Addition to Scientific Advisory Board
RNS
RNS Number : 0497T
Motif Bio PLC
15 July 2015

15 July 2015

Motif Bio plc

("Motif" or the "Company")



Motif Bio Appoints Dr. Thomas M. File to its Scientific Advisory Board

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced the appointment of Dr. Thomas M. File to its Scientific Advisory Board. Currently, Dr. File, a renowned expert in infectious diseases, Chairs the Division of Infectious Diseases at Summa Health System, Akron, Ohio, is Professor of Internal Medicine and Master Teacher, and the Chair of the Infectious Disease Section of Northeast Ohio Medical University (NEOMED).

Dr. File is a highly respected and internationally recognized expert on infectious diseases including skin and skin structure infections (SSSIs) and pneumonia. Previously, Dr. File served as Past-President and as a member of the Board of Directors for the National Foundation for Infectious Diseases and on the Board of Directors for the Infectious Disease Society of America. In 2010, he was elected as a Faculty Member to the Alpha Omega Alpha Honorary Society and in 2013, was recipient of the Watanakunakorn Clinician Award of the Infectious Diseases Society of America.

Over the last 38 years, Dr. File has published over 275 original papers and numerous review articles and delivered some 145 presentations on various aspects of infectious diseases at scientific meetings throughout the USA and internationally. He currently, serves on the Editorial Boards of Infectious Diseases in Clinical Practice, where he is Editor-in-Chief; Infectious Disease News; plus the Journal of Microbiology and Immunology and Infection.

Dr. David Huang, Chief Medical Officer at Motif Bio plc, commented: "We are very pleased to welcome Dr. Tom File to our team of scientific experts. Dr. File's extensive clinical and research knowledge in infectious diseases, especially in the management and treatment of SSSIs and pneumonia, will provide critical expert input into the clinical development of our anti-bacterial programmes for serious and life threatening conditions."

15 Jul Northland... 89.00 Buy