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 conduct in vivo preclinical 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, including Staphylococcus aureus
– Iclaprim was granted U.S. orphan drug designation for S. aureus pneumonia 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 an in vitro model for ocular toxoplasmosis, a parasitic disease that may result in severe life-threatening infections and/or blindness
– Iclaprim has shown promising activity against toxoplasma in 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 theInstitute of Inflammation and Neurodegeneration atOtto-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.
“In parallel, we’re continuing our broader business development efforts to in-license or acquire additional assets. Multiple opportunities are currently under evaluation based on our proactive efforts as well opportunities that have been presented to us based on our demonstrated ability to execute successful late-stage clinical studies. Our goal is to position
No new material information was disclosed during the meeting.
The AGM was then adjourned until
For further information please contact:
Motif Bio plc | ir@motifbio.com |
Graham Lumsden (Chief Executive Officer) | |
Walbrook PR Ltd. (UK FINANCIAL PR & IR) | +44 (0)20 7933 8780 |
Paul McManus/Lianne Cawthorne/Helen Cresswell | motifbio@walbrookpr.com |
Peel Hunt LLP (NOMAD & JOINT BROKER) | + 44 (0)20 7418 8900 |
Dr Christopher Golden | |
Oliver Jackson | |
SP ANGEL CORPORATE FINANCE LLP (JOINT BROKER) | +44 (0)20 3470 0470 |
David Hignell/ Vadim Alexandre /Rob Rees | |
MC Services AG (EUROPEAN IR) | +49 (0)89 210 2280 |
Raimund Gabriel | raimund.gabriel@mc-services.eu |
LifeSci Advisors (U.S. IR) | +1 (646) 597 6989 |
Bob Yedid | bob@lifesciadvisors.com |
Russo Partners (U.S. PR) | +1 (858) 717 2310 or +1 (212) 845 4272 |
David Schull | david.schull@russopartnersllc.com |
Note to Editors:
About
The Company also has 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 in patients with HABP has been successfully completed and a Phase 3 trial is being planned. Additionally, iclaprim has been granted orphan drug designation by the
Iclaprim received Qualified Infectious Disease Product (QIDP) designation from the
Forward-Looking Statements
This press release contains forward-looking statements. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Motif Bio’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.