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/

Leading CRO to Conduct Iclaprim Phase III Trials
RNS
RNS Number : 4594C
Motif Bio PLC
16 October 2015

16 October 2015



Motif Bio plc

("Motif" or the "Company")

Contract Signed With Leading CRO to Conduct Iclaprim Phase III Clinical Trials



Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced the signing of a clinical trials agreement with Covance, a leading global Contract Research Organisation (CRO), and a wholly owned subsidiary of Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH). The trials under the agreement are for iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA.

Covance will run two Phase III randomised, double blind, multicentre clinical trials with iclaprim. The trials will evaluate the efficacy and safety of intravenous iclaprim versus intravenous vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSI). In addition to Covance's considerable experience running antibiotic trials, a key consideration for Motif in selecting Covance as its development partner, was the ability to leverage LabCorp's powerful patient data for these trials.

David Huang, Chief Medical Officer at Motif, said: "The signing of this agreement with Covance is a great step forward for Motif and its development strategy for iclaprim, and ensures a timely start of the Phase III programme. We are now progressing with the selection of countries and investigator sites; programme study drug logistics; and submission of regulatory documents to health authorities, institutional review boards, and independent ethics committees worldwide. Motif remains firmly on track to meet its goal of marketing iclaprim in 2018."

Who Should Attend?Date:

Wednesday 4th November 2015

Venue:

Novotel Tower Bridge, London EC3N, 10 Pepys Street, London, EC3N 2NR

Event Timings:Sponsored by:

European Agreement for Iclaprim Development
RNS
RNS Number : 2712F
Motif Bio PLC
11 November 2015

11 November 2015



Motif Bio plc

("Motif" or the "Company")



European Agreement for Iclaprim Phase III Clinical Development Programme



Motif Bio plc (AIM:MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received written advice from a Scientific Advice Meeting with the Medicines Evaluation Board (MEB) in Utrecht, The Netherlands, held on 16 September 2015, in relation to the Phase III Clinical Development Programme for iclaprim.

The MEB's advice confirms that two Phase III clinical trials plus microbiological data derived from the planned surveillance studies, are acceptable as pivotal registration studies for approval in the European Union through the "centralized" regulatory procedure of intravenous iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA.



Dr. David Huang, Chief Medical Officer at Motif, said: "With MEB acceptance of our proposal for two Phase III clinical trials for iclaprim, Motif remains firmly on track to meet its goal of completing the two ABSSSI trials in 2017, and submitting a Marketing Authorisation Approval in Europe

Proactive investors -

Broker upgrade for Motif Bio with NASDAQ listing ahead


15:35 27 Jul 2016

Analysts at Northlands Capital said there was a “chronic under-investment” in antibiotic resistance.

Resistant bacterium

Anti-biotic resistance is a major health concern for medical bodies across the world.


Anti-biotic resistance is a major health concern for medical bodies across the world and one that needs to be addressed fast.

The world could face 10mln lives lost every year and up to US$100trn in lost productivity by 2050, according to experts.

An estimated 50,000 deaths already occur annually across Europe and the US due to antibiotic resistance.

Currently listed on London’s junior market AIM, the biotech group Motif Bio Plc (LON:MTFB) is developing new types of anti-biotics to combat resistance.

The development of novel antibiotics is an important part of the solution to this looming crisis.

In preparation for its up-coming US drug launch, earlier this month Motif Bio said it planned to list on NASDAQ.

Analysts at Northlands Capital said there was a “chronic under-investment” in the area by the pharmaceutical industry, but that means big potential for Motif.

The broker said that a US listing could help bridge the significant valuation gap between Motif and its US peers.

Other companies operating in the same field in the US include Cempra (NASDAQ:CEMP) and Paratek (NASDAQ:PRTK), both listed on NASDAQ, are valued significantly more than Motif.

“We believe that the discrepancy in pricing between the group and its US-peers would be thrown into sharp relief,” said the analysts.

Motif already has all-important FDA consent to conduct Phase 3 clinical trials for iclaprim in two requested indications, Acute Bacterial Skin and Skin Structure Infections and Hospital Acquired Bacterial Pneumonia.

Northland estimates sales of the treatments could easily reach billions of dollars a year once it reaches the commercial market.

Through the listing, Motif expects to raise up to US$60mln selling around 100mln shares.

With the potential of the drug in the US and the up-coming listing, Northlands Capital has raised its target price from 114p to 140p, indicating a significant potential upside of 200% on the current price of 48p per share.

Can Motif Bio really surge 400%? - By David Brenchley | Wed, 5th April 2017 - 13:14

When was the last time you were told there was an investment that could make five times your money? Well, broker finnCap thinks Motif Bio (MTFB), the company behind a late-stage antibiotic called iclaprim, could do the job.

Initiating coverage of the AIM-listed shares, analyst Alex Pye thinks they could be worth 125p. After funding concerns last autumn dumped the shares from 53p to 21p – just a penny above the 2015 IPO price of 20p - that bullish target implies potential upside of a colossal 400%.

However, don't put that deposit down on the new Ferrari just yet! Pye's objective is the product of a 13-year view, reflecting a net present value of £245 million using a risk-adjusted discounted cash flow model.

So, it could be a long road, and there's a bucketload of risk here, but there are also plenty of potential catalyst events to get the shares shifting in the right direction. And finnCap believes a re-rating, at least, could begin soon.



Watch for a positive phase III REVIVE data readout in the second quarter of 2017, says Pye. This is the clinical trial investigating the safety and efficacy of iclaprim to treat patients with Acquired Bacterial Skin and Skin Structures Infection (ABSSSI).

He points out that shares in Nasdaq–listed Achaogen more than tripled overnight last December following positive phase III results for its gram-negative candidate plazomicin, another drug which attacks super bugs.

But Motif Bio is short of cash and needs another $10 million to complete its second phase III trial, REVIVE-2. FinnCap believes that a positive REVIVE-1 readout should attract potential backers and make an equity fundraising much easier.

"Motif worked closely with the US Food and Drug Administration (FDA) in designing these pivotal trials and if primary endpoints are reached successfully, we expect the shares to be re-rated," writes Pye.

There could also be upside if Motif Bio agrees a partnering licence agreement with a "notable and respected pharmaceutical company for upfront payments and reduced development costs", Pye says. Grant funding from numerous possible sources would be a further catalyst.

Comparable antimicrobials have already gained approval, he explains: "Daptomycin [achieved] more than $1 billion global sales, all with similar clinical trial designs."

Motif Bio shares are already inching higher as finnCap's argument is very persuasive, but small biotechs like this are incredibly high risk.

Confidence took a huge hit late last year funding issues arose and, although money was forthcoming, the company needs more, potentially up to $42 million to complete Phase III trials in Hospital-Acquired Bacterial Pneumonia (HABP) for iclaprim. Thankfully, REVIVE-1 results are expected before net cash falls below zero.

There's also a chance that these results will be disappointing. But here, too, Pye thinks risk is mitigated by the "overwhelmingly positive" historical Phase II and III data that support the safety and efficacy of iclaprim.

As we wrote in June 2015, one to watch.

Is this massive fall ( 40p to abt 7p, mid-Feb 2019 ), only due to repaying a large loan? Surely Motif knew it would become due.... and where will the money come from... is this asking Shareholders for cash likely - about that 7p point?
How is the Bio-part going? I see no mention of any "Failure" but wonder why the sp rose from 25p last Dec.up to 40p - this is usually in anticipation of Trial-Success. Must presume "Fall" is the likelyhood of a cash-call. . . . . Anyone?