MerLion and Dstl Awarded DTRA Grant to Explore the Use of Finafloxacin against Biological Threat Age

MerLion Pharmaceuticals ("MerLion") today announced that a joint project with the Defence Science and Technology Laboratory, UK (Dstl) titled "‘Efficacy of Finafloxacin against Biological Threat Agents" has been awarded a grant from the United States’ Defense Threat Reduction Agency (DTRA) Chemical and Biological Defense Program.

The multi-year, multi-phase project will study the impact of MerLion’s novel fluoroquinolone finafloxacin for the treatment of infections caused by the biological threat agent Burkholderia pseudomallei (B. pseudomallei).  In addition, the broad spectrum efficacy of finafloxacin against other intracellular bio-threat agents such as Francisella tularensis (F. tularensis) and Yersinia pestis (Y. pestis), and other multi-drug resistant (MDR) pathogens of clinical significance will be investigated in further detail.

During the initial period of the project MerLion and Dstl will work towards gaining U.S. Food and Drug Administration (FDA) agreement about the next steps for the development of finafloxacin as an approved antibiotic.

This project will build on data generated both in vitro and in vivo in an existing long-standing collaboration between Dstl and MerLion which has shown that, in addition to activity against MDR pathogens, finafloxacin has significant potential for the treatment of bio-threat agents. Finafloxacin has already demonstrated strong and rapid-onset activity against B. pseudomallei, F. tularensis and other intracellular bio-threat pathogens.

Finafloxacin acts powerfully against two bacterial molecular targets and its rapid bactericidal effect is further enhanced by its activity in the acidic environment found at most sites of bacterial infection.  

In addition, finafloxacin has been shown to be a poor substrate of the major multidrug efflux transporters which affect other fluoroquinolones and is thus able to maintain its efficacy against fluoroquinolone-resistant B. pseudomallei where resistance caused by efflux pumps is predominant.

MerLion has previously reported positive results for finafloxacin from a Phase 2 study in patients hospitalized with complicated urinary tract infections (cUTI) and pyelonephritis which showed that a five day course, starting with IV and switching to oral dosing, was more effective that treatment with the current standard of care (ciprofloxacin).

"We already have compelling pre-clinical results generated in the collaboration with our partners from Dstl for finafloxacin’s activity against various bio-threat pathogens, as well as data from our positive clinical studies treating patients with cUTI infections", said David Dally, CEO of MerLion.

He added that "The new project will enable us to investigate the activity of finafloxacin against a variety of very difficult-to-treat pathogens in more detail and will help to position finafloxacin as an effective therapy against multiple bioterrorism threats, as well as a treatment for other life-threatening infections."