Motif Bio Plc (LON:MTFB) CEO Dr. Graham Lumsden chats to DirectorsTalk about the Phase III Clinical Trials 80mg fixed dose. Graham explains why a fixed dose is important, how this benefits the company, patients and clients and how the 80mg dose was determined.
Iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA, will be tested in randomised, double blind, multicentre clinical trials to evaluate the efficacy and safety of intravenous iclaprim versus intravenous vancomycin in the treatment of ABSSSI. The iclaprim fixed dose regime can help reduce the time required for dosage adjustment or monitoring by healthcare professionals in renally impaired or obese patients, leading to reduced overall hospital treatment costs in these high risk patient populations. Studies have found that hospitalized patients with ABSSSI have a higher occurrence of obesity and renal impairment than in the general adult population. Obesity can affect the pharmacokinetics and pharmacodynamics of many drugs, including antimicrobial therapies, potentially leading to suboptimal drug concentrations in serum or tissue. Obese patients have been found to be at risk for clinical failure following inadequate dosing of antimicrobial therapy.
Motif Bio Plc is a clinical stage biopharmaceutical company which specializes in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings. Motif is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram positive and Gram negative bacteria.
Antibiotic resistance has limited the effectiveness of many existing drugs. The discovery of new antibiotics to address this resistance has not kept pace with the increasing incidence of difficult‐to‐treat bacteria. Without new antibiotics effective against resistant bacteria, the risk is that within five to ten years, routine surgeries such as hip and knee replacements, cardiac catheterization, caesarian section, and coronary artery bypass grafts would be impossible without effective antibiotics. One of the biggest threats is from methicillin‐resistant staphylococcus aureus (“MRSA”), a leading cause of hospital‐acquired infections and a growing cause of infections in healthy people. In 2013, the Centers of Disease Control (“CDC”) reported that at least 2M people became infected with bacteria that are resistant to antibiotics and at least 23,000 Americans died as a direct result of these infections – more than the annual number of deaths of people diagnosed with AIDS.
Given the urgent need to find new antibiotics to address this problem, Motif has a dedicated effort in developing new best‐in‐class antibiotics, each targeting different and unique mechanisms of action to be effective against bacteria that are resistant to most currently available antibiotics.
