NEW YORK, June 06, 2019 (GLOBE NEWSWIRE) — Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the Company has received the official minutes of the Type A meeting the Company held with the U.S. Food & Drug Administration (FDA or Agency) on May 3, 2019, to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for iclaprim, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The minutes indicate that an additional clinical trial will be required prior to granting marketing approval to address the Agency’s continued concerns about potential liver toxicity. The Company has been encouraged by the FDA to put forth a proposal for a future study and to submit it for review. The Company plans to request a meeting with the Agency to discuss the design of the study, including the appropriate patient population to be evaluated.
Dr. Graham Lumsden, Chief Executive Officer, said: “We now have confirmation of what will be required for a path forward for iclaprim. We intend to meet with the Agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements. In parallel, we expect to continue our discussions with potential commercial partners and will determine the best options for funding the trial once we have clarity from the FDA.”
“We continue to believe that iclaprim has the potential to be an important new treatment option for hospitalised patients with ABSSSI and potentially also in patients with hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia. In addition, we are exploring the use of iclaprim in other disease areas, including orphan indications such as Staphylococcus aureus lung infections in patients with cystic fibrosis and in ophthalmology, as evidenced by recently announced collaborative agreements. Completing the steps necessary to provide the additional trial data to respond to the Complete Response Letter is our top priority. We are also continuing our business development activities to position Motif Bio for long-term growth by building a robust development pipeline. In parallel with our focus on iclaprim, we continue to pursue a variety of attractive opportunities in the anti-infectives space, as well as in other key therapeutic areas.”
As of May 31, 2019, the Company had a cash balance of $2.3 million and $7.1 million of outstanding debt drawn from the Hercules Loan Facility. The Company believes the current cash position can support continued operations into September 2019 with diligent cash management. The Company will need to raise additional capital, which may be through equity financing and/or from non-dilutive sources. The Company is evaluating options to determine the funding strategy that will be most favourable for shareholders and will provide an update to the market in due course.