Motif Bio reports half-year 2017 financial results and operational progress

NEW YORK, Sept. 29, 2017 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical stage biopharmaceutical company specializing in developing novel antibiotics, today announced financial results for the half-year ended June 30, 2017.

 Business Update

• In April 2017, Motif Bio announced positive top-line results from REVIVE-1, a global Phase 3 clinical trial of its investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections (“ABSSSI”). Iclaprim achieved the primary endpoint of non-inferiority (10% margin) compared to vancomycin at the early time point, 48 to 72 hours after start of study drug administration in the intent-to-treat patient population. Given its differentiated mechanism, potency, spectrum, safety and efficacy, iclaprim, if approved, could provide a valuable new antibiotic treatment option. Iclaprim was well tolerated in the study, with most adverse events categorized as mild.
   
• The operational team and Board of Directors of Motif Bio were strengthened by the appointments of Robert Dickey IV as Chief Financial Officer in January 2017 and Dr. Craig T. Albanese, Chief Operating Officer of the Morgan Stanley Children's Hospital, as a non-executive director in May 2017.
   
• Motif Bio made three appointments to its Clinical Advisory Board: Dr. Thomas Lodise, Dr. Thomas Holland and Dr. William O'Riordan. These experts participated in Motif Bio’s recent Investor and Analyst Event, providing insight on ABSSSI, current treatments and iclaprim’s potential role in treating this serious skin infection.

After the period end, Motif Bio continued to make strong operational and strategic progress:

• In August 2017, Motif Bio announced that the last patient had completed the treatment phase in REVIVE-2, the second Phase 3 clinical trial investigating the safety and efficacy of iclaprim in patients with ABSSSI. 
   
• In September 2017, Motif Bio announced that the US Food and Drug Administration (“FDA”) granted Orphan Drug Designation to iclaprim for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis. This designation grants special status to a drug or biologic under development to treat a rare disease or condition and qualifies the sponsor of the product for various development incentives, including tax credits for qualified clinical testing, waiver of user fees and potentially up to seven years of market exclusivity for the given indication, if approved.

Top-line results from REVIVE-2, which uses an identical protocol to REVIVE-1 but has different trial centers, are expected in the fourth quarter of 2017. Motif Bio believes that the successful completion of the REVIVE-1 and REVIVE-2 Phase 3 trials satisfy both FDA and European Medicines Agency (“EMA”) requirements for regulatory submission for an IV formulation of iclaprim in the treatment of ABSSSI.  Motif Bio continues to anticipate submission of a New Drug Application (“NDA”) for iclaprim for the treatment of ABSSSI in the United States in the first quarter of 2018 and a Marketing Authorization Application (“MAA”) for iclaprim for the treatment of ABSSSI in Europe in the first half of 2018.

Financial Highlights

• In June 2017, Motif Bio raised US$23.7 million of net proceeds, after deducting US$1.7 million of issuance costs, from a placement in the United Kingdom of 66,666,667 new ordinary shares at 30 pence per share.        
• At June 30, 2017 and December 31, 2016, Motif Bio’s cash and cash equivalents were US$29.5 million and US$21.8 million, respectively. At September 22, 2017, Motif Bio’s cash and cash equivalents were $18.1 million.
• Net loss for the six months ended June 30, 2017 and 2016 was US$29.7 million and US$14.2 million, respectively.

Motif Bio’s interim financial results for the six months ended June 30, 2017 are available on its website (www.motifbio.com) in the Investors section.

Motif Bio’s strategy is focused on gaining approval for and commercializing iclaprim for ABSSSI and the continued development of iclaprim for additional indications to potentially broaden its use as a safe and effective antibiotic. In this regard, Motif Bio has completed the necessary steps to initiate a Phase 3 clinical trial of iclaprim for the treatment of hospital-acquired bacterial pneumonia (“HABP”), including ventilator-associated bacterial pneumonia (“VABP”). However, Motif Bio will be required to raise additional capital within the next year to commercialize and further develop iclaprim and to continue to fund operations.

Graham Lumsden, Chief Executive Officer of Motif Bio, said: “We have continued to deliver on time or ahead of expectations on key milestones this year, including the release of positive top-line data from the REVIVE-1 Phase 3 trial with iclaprim in April and the completion of the treatment phase for the REVIVE-2 trial in August.  We remain on track to announce the top-line results from REVIVE-2 in the fourth quarter of this year and to submit a New Drug Application to the FDA by the end of the first quarter of next year. If the NDA is accepted by the FDA, we expect that iclaprim will qualify for a priority review and a decision on approval to market is anticipated to come by the end of 2018.”

 “The team has accomplished a tremendous amount in a little over two years since our AIM IPO. We are now focused on the pre-commercialisation activities to prepare for a potential launch in 2019. The recent announcement of an orphan designation for iclaprim in the treatment of Staphylococcus aureus pneumonia in cystic fibrosis patients adds another potential indication where we may be able to help patients in need of safe and effective antibiotics in a life-threatening situation.”  

Note to Editors

About Motif Bio

Motif Bio plc (AIM/NASDAQ:MTFB) is a clinical-stage biopharmaceutical company engaged in the research and development of novel antibiotics designed to be effective against serious and life-threatening infections in hospitalised patients caused by multi-drug resistant bacteria, including MRSA. Motif Bio’s lead product candidate, iclaprim, is being developed for high-risk MRSA patient populations. The first proposed indication, and near-term commercial opportunity, is for the treatment of acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the US. Motif Bio believes that iclaprim may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike current standard of care antibiotics, in clinical trials to date, nephrotoxicity has not been observed with iclaprim and dosage adjustment has not been required in patients with renal impairment.

Iclaprim has an underutilised mechanism of action compared to other antibiotics.  Clinical and microbiology data indicate iclaprim has a targeted Gram-positive spectrum of activity, low propensity for resistance development, fixed dose administration and favourable tolerability profile. Additionally, data support that the inactive metabolites of iclaprim clear through the kidneys. Motif Bio also plans to develop iclaprim for hospital acquired bacterial pneumonia (HABP), including ventilator associated bacterial pneumonia (VABP), as there is a high unmet need for new therapies in this indication.  A Phase 2 trial was conducted to study iclaprim in patients with HABP. Iclaprim has been studied in an animal model of chronic pulmonary MRSA infection which mimics the pathophysiology observed in patients with cystic fibrosis. Results from this study will be presented at IDWeek on October 6, 2017 in San Diego, CA. Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status. Upon acceptance by the FDA of a New Drug Application (NDA), iclaprim will receive Priority Review status and, if approved as a New Chemical Entity, will be eligible for 10 years of market exclusivity in the US from the date of first approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe, 10 years of data exclusivity is anticipated.

Forward-Looking Statements

This press release contains forward-looking statements that reflect Motif Bio's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of Motif Bio’s product candidates, and the clinical benefits, safety profile, and commercial potential of iclaprim. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of Motif Bio’s clinical development strategies, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of iclaprim and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in Motif Bio can be found in Motif Bio’s UK published Annual Report & Accounts and on Form 20-F, filed with the U.S. Securities and Exchange Commission on May 1, 2017. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Motif Bio undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.