Motif Bio plc, a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announces that at the Company’s AGM held earlier the Company provided the following review of key aspects of its business and growth strategy.
Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announces that at the Company’s AGM held earlier today the Company provided the following review of key aspects of its business and growth strategy.
Iclaprim for treating ABSSSI (acute bacterial skin and skin structure infections)
- Type A meeting held with the U.S. FDA on 3rd May to discuss the path forward
- Additional data likely will be required to address the Agency’s concern about a risk of liver toxicity, the size and scope of which will determine the specific next steps
- Motif Bio to provide an update once the minutes of the meeting are received
- Intention remains to partner Iclaprim upon marketing approval for commercialisation in the U.S. and other global markets
- Strengthen IP portfolio and partnering position in ex-U.S. markets by filing method-of-use patents covering fixed dose of Iclaprim
Near-term expansion opportunities for Iclaprim
- Cystic fibrosis (Agreement with Lamellar Biomedical Limited)
-To conductin vivopreclinical studies evaluating Iclaprim in combination with LBL’s LMS-611
-Complementary mechanisms of action: LMS-611 breaks down mucus in the lungs of CF patients, enabling greater penetration and enhanced activity of antibiotics; Iclaprim accumulates in the lung alveolar macrophages and has activity against CF-relevant bacteria, includingStaphylococcus aureus
-Iclaprim was granted U.S. orphan drug designation forS. aureuspneumonia in patients with CF and LMS-611 has European orphan drug designation for CF
-Lamellar also has a disease-modifying gene therapy product candidate
- Toxoplasma chorioretinits (Agreement with Otto-von-Guericke University, Magdeburg)
-To evaluate Iclaprim in anin vitromodel for ocular toxoplasmosis, a parasitic disease that may result in severe life-threatening infections and/or blindness
-Iclaprim has shown promising activity against toxoplasmain vitro
-Study is planned to focus on toxoplasma chorioretinitis, a progressive and recurring necrotizing retinitis
-To be led by Prof. Dr. Ildiko Rita Dunay, a toxoplasmosis expert and Director of the Institute of Inflammation and Neurodegeneration at Otto-von-Guericke University
Additional business development initiatives
- A concerted business development effort has been ongoing
- Proactively sought and will continue to seek to license or acquire assets that could enhance and/or broaden the Company’s development pipeline
- Continue to be approached and presented with opportunities based on Motif Bio’s demonstrated ability to execute successful late-stage clinical studies
- Currently evaluating a number of licensing and partnering opportunities
- Look forward to discussing additional pipeline developments at the appropriate time
Additional updates
- Sufficiently funded to reach a decision point regarding Iclaprim based on the outcome of interactions with the FDA
-As in the past, Motif Bio will continue to evaluate options to determine the funding strategy that is most favorable for shareholders and provides flexibility to execute on our clinical and business development activities
- Enhanced Board of Directors with the appointment of Andrew Powell, J.D. as Non-executive Director
-Extensive experience in the life sciences industry and strong expertise in commercialization strategy, corporate expansion, governance and M&A
- Continued to establish Motif Bio within the anti-infectives industry
-April 2019: Presented new Iclaprim data at ECCMID 2019
-Announced yesterday three poster presentations at upcoming ASM Microbe 2019
Summarising Dr. Graham Lumsden, Chief Executive Officer of Motif Bio, said: “We are very confident in our lead compound Iclaprim’s broad potential as a differentiated and targeted anti-infective agent, based on the strong clinical safety and efficacy data we have generated and the important unmet medical and health-economic needs we believe Iclaprim may fulfill within the hospital-based antibiotic landscape and other indications. In addition to pursuing our first potential approval and commercial partnership for Iclaprim, we are committed to maximizing opportunities to further expand the value of this asset. We recently announced two collaborative agreements to evaluate Iclaprim’s ability to address high-need orphan diseases within lung disease and ophthalmology.
