Motif Bio (AIM/NASDAQ: MTFB) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics to treat hospitalized patients with serious and life-threatening infections caused by multi-drug resistant bacteria. Motif’s lead product candidate is iclaprim, a targeted Gram-positive1 antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA). Iclaprim works in a different way than most other antibiotics and rapidly kills bacteria in vitro. The first proposed indication for iclaprim is acute bacterial skin and skin structure infections (ABSSSI), one of the most common bacterial infections, with 3.6 million patients hospitalized 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 current standard of care Gram-positive 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. Motif has announced positive results from two Phase 3 clinical trials. The Company has initiated a rolling New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) for marketing approval, which is expected to be completed in the second quarter of 2018. Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA together with Fast Track status. Iclaprim qualifies for Priority Review status and, as a New Chemical Entity, iclaprim is 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 the European Union (EU), iclaprim qualifies for eight years of data exclusivity and an additional two years of market exclusivity. Other potential indications for iclaprim include hospital acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP), and Staphylococcus aureus lung infections in people with cystic fibrosis. The FDA has granted orphan drug designation to iclaprim for treatment of Staphylococcus aureus lung infections in patients with cystic fibrosis.
- Gram-positive and Gram-negative refer to how bacteria react to the Gram stain test based on the outer casing of the bacteria and the bacteria’s cell wall structure. Each type of bacteria may be associated with different diseases