Big Picture – A Deep Dive Examination of Motif Bio PLC
Motif Bio PLC Snapshot
Motif Bio is focused on developing novel antibiotics to treat hospitalized patients with serious and life-threatening infections caused by multi-drug resistant bacteria. Our initial focus is on iclaprim, a targeted antibiotic with activity against MRSA (methicillin-resistant Staphylococcus aureus).
Iclaprim: Iclaprim is a novel investigational antibiotic that is being developed for high-risk MRSA patient populations. Following positive results from two Phase 3 trials (REVIVE-1 and REVIVE-2), a rolling submission of a New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) has been initiated and is expected to be completed in the second quarter of 2018.
Iclaprim has a different and underutilised mechanism of action compared to other antibiotics and exhibits potent in vitro activity against Gram-positive clinical isolates of many genera of staphylococci, including MRSA. Iclaprim is rapidly bactericidal, achieving 99.9% in vitro kill against MRSA within 4 to 6 hours of drug exposure versus 8 to 10 hours for vancomycin. To date, iclaprim has been studied in over 1,400 patients and healthy volunteers. In clinical studies iclaprim has been administered intravenously at a fixed dose with no dosage adjustment required in patients with renal impairment or in obese patients. The iclaprim fixed dose may, if approved, help reduce the resources required in hospitals since dosage adjustment by health care professionals is avoided and overall hospital treatment costs may be lower, especially in patients with renal impairment.
ABSSSI, the lead indication for iclaprim, is one of the most common bacterial infections, with 3.6 million patients hospitalised annually in the U.S. The Company believes that iclaprim may be suitable for first-line empiric therapy in ABSSSI patients, especially those with renal impairment, with or without diabetes. Unlike many standard of care antibiotics, iclaprim is only minimally cleared via the kidneys (<2% of the administered dose was recovered unchanged in the urine). No nephrotoxicity was observed with iclaprim in the REVIVE Phase 3 trials and dosage adjustment has not been required in patients with renal impairment.
Motif 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 granted orphan drug designation by the U.S. FDA for the treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis and is currently in preclinical testing for this indication.
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 U.S. from the date of first approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act). In Europe, 10 years of market exclusivity is anticipated.
Graham Lumsden, Chief Executive Officer
Graham G. Lumsden, Chief Executive Officer of Motif, is responsible for all aspects of the strategy, management, and operations of the Company. Prior to joining Motif, Mr. Lumsden was a senior executive at Merck & Co., Inc. where he held commercial leadership positions in worldwide businesses including contraceptives and osteoporosis. Mr. Lumsden has a proven record of success leading change and delivering results in subsidiary and global leadership positions, including new product launches, pre-clinical/clinical development, regulatory strategy, cross-functional team leadership, IP strategy/litigation, and domestic/international sales and marketing. Mr. Lumsden is a member of the Royal College of Veterinary Surgeons (MRCVS), holds a postgraduate diploma from the Chartered Institute of Marketing (MCIM), and is a dual citizen of the U.S. and UK.
Jonathan E. Gold, Interim Chief Financial Officer
Mr. Gold has a history of senior financial positions and is currently Managing Director of JEG Capital Partners LLC, a family office and asset manager. He previously was a portfolio manager for the Federated Kaufmann Funds. Prior to that, Mr. Gold was a venture capitalist and was active in financing and building life sciences and technology companies. Mr. Gold received his B.S. and MBA in Finance from New York University’s Stern School of Business.
David Huang, M.D., Ph.D, Chief Medical Officer
Dr. Huang is a senior pharmaceutical research executive, and the former Chief Medical Officer at ContraFect Corporation. Dr. Huang also led a drug development group in anti-infectives at Pfizer. Dr. Huang has over 15 years of clinical, academic and research experience in infectious diseases. He has served as a faculty member at Baylor College of Medicine and currently as an adjunct Assistant Professor at Rutgers New Jersey Medical School. He continues to see patients at the Veterans Affairs Medical Center in Houston. His research interests include bacteriology and virology, especially the epidemiology, pathogenesis, and treatment of multi-drug resistant organisms. He is experienced in designing, executing and closing out Phase I – III clinical trials for both antibacterials and antiviral agents. Dr. Huang completed his medical school at the University of Texas at Houston Medical School, and completed his internship and residency in internal medicine at the University of Texas at Southwestern and fellowship in infectious diseases at Baylor College of Medicine. He is board-certified in both internal medicine and infectious diseases.