(12th April 2018) Positive Phase II Data of Finafloxacin Antibiotic Published in Three Papers in Antimicrobial Agents and Chemotherapy

Positive Phase II Data of Finafloxacin Antibiotic Published in Three Papers in Antimicrobial Agents and Chemotherapy

 

Singapore, 12 April 2018 - MerLion Pharmaceuticals (MerLion) today announced that three papers summarizing clinical data from its Phase II clinical trial with finafloxacin in complicated urinary tract infections (cUTIs) have been published online in the peer-reviewed journal Antimicrobial Agents and Chemotherapy and in the print version of the April issue. Finafloxacin is a novel antibiotic that, as well as an outstanding safety profile, demonstrates strong antibacterial activity under acidic conditions; differentiating it from other existing antibiotic therapies and offering new, exciting treatment opportunities.

"The publication of these papers re-enforce the great outcomes of our Phase II clinical studies with finafloxacin in cUTIs and is exciting news for MerLion. Urinary tract infections (UTIs) account for approximately 40% of all hospital-acquired infections, with a prevalence of about 10% in hospitalized urological patients. UTIs also result in more than 100,000 hospital admissions every year in the U.S. alone,” said David Dally, CEO of MerLion Pharmaceuticals.

“The clinical data supports our view that finafloxacin offers new, unique and highly efficient treatment options for such infections in a very attractive market."

The titles and summaries of the publications are as follows:

Explorative Randomized Phase II Clinical Study of the Efficacy and Safety of Finafloxacin versus Ciprofloxacin for Treatment of Complicated Urinary Tract Infections
This Phase II clinical study compared the efficacy and safety of finafloxacin and ciprofloxacin in patients with complicated urinary tract infection and/or pyelonephritis. A 5-day regimen with 800 mg of finafloxacin given once a day had results similar to those of a 10-day regimen with 800 mg finafloxacin given once a day. Combined microbiological and clinical responses at the test-of-cure visit for the 193 patients in the microbiological intent-to-treat (mITT) population were: 70% for patients treated with finafloxacin for 5 days, 68% for patients treated with finafloxacin for 10 days and 57% for a 10-day ciprofloxacin regimen. Additionally, the clinical effects on patients with an acidic urine pH (80% of patients) treated with ciprofloxacin were reduced, whereas the effects of finafloxacin were unchanged. Finafloxacin was safe and well tolerated.

Early clinical assessment of the antimicrobial activity of finafloxacin compared to ciprofloxacin in sub-sets of microbiologically characterized isolates
The early response to finafloxacin was evaluated in two Phase II clinical studies with patients with urinary tract infections. Finafloxacin demonstrated early and rapid activity against uropathogens, including fluoroquinolone resistant and/or multi-resistant pathogens or ESBL producers, while ciprofloxacin was less active against this subset of resistant pathogens.

Population pharmacokinetics of finafloxacin in healthy volunteers and patients with complicated urinary tract infections
Data from three clinical trials were evaluated. A population pharmacokinetic model and pharmacokinetic/pharmacodynamic relationships were investigated via simulations and logistic regression. A two-compartment model with first-order elimination described the data best (central volume of distribution and peripheral volume of distribution of 47 liters (20%) and 43 liters (67%), respectively, and elimination clearance and intercompartmental clearance of 21 liters/h (54%) and 2.8 liters/h (57%), respectively.

MerLion is exploring a number of options which could enable Phase III trials in cUTI to begin within 24 months.

 

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Contacts:

MerLion: 

Instinctif Partners (for media enquiries)

 
David Dally, CEO
Tel: +65 6778 5700
E-mail: enquiry@merlionpharma.com

Sue Charles / Gemma Howe
Tel: +20 7866 7860
E-mail: merlion@instinctif.com


About MerLion Pharmaceuticals

MerLion Pharmaceuticals Pte Ltd is a pharmaceutical company, headquartered in Singapore with R&D operations in Berlin, Germany, which is focused on the advanced clinical development of its antibacterial lead program, finafloxacin. MerLion is a privately held company supported by a group of leading global investors including Aravis Venture, Singapore based EDBI and Heidelberg Capital.  For more information please visit 
www.merlionpharma.com

About Finafloxacin

Finafloxacin is a novel fluoroquinolone antibiotic with many “best in class” features. In clinical and pre-clinical settings the compound has shown a substantially improved therapeutic profile as compared to the existing gold standard and a broad utility in treating many severe infections, including those caused by resistant Gram-negative pathogens.

Finafloxacin’s superior profile arises from the compound’s unique mode of action, being equally active at physiological pH conditions and in the acidic environments which occur at the most sites of bacterial infections. Most other antibiotics, including other fluoroquinolones, show decreased activity under acidic tissue conditions, which results in a significant reduction of their overall efficacy.

Results from a double-blind controlled Phase II clinical trial revealed a higher, more rapid and sustained level of microbiological eradication and improved clinical outcomes for patients treated with finafloxacin compared to those treated with ciprofloxacin. The trial’s primary and secondary end points were all successfully achieved. Finafloxacin was found to be both safe and well tolerated.

MerLion has developed intravenous and oral formulations of finafloxacin with equivalent bioavailability, offering physicians various options for in-hospital and out-patient treatment regimens. 

In 2014 Xtoro™, an otic suspension of finafloxacin, was approved by the FDA for treatment of acute otitis externa, commonly known as “swimmer’s ear”, caused by Pseudomonas aeruginosa and Staphylococcus aureus. MerLion retains all rights to market Xtoro™ outside North America.

The impact of finafloxacin for the treatment of infections caused by the biological intracellular threat agents Burkholderia pseudomallei, Francisella tularensis, Yersinia pestis and other multi-drug resistant (MDR) pathogens of clinical significance are currently being investigated in a joint project with the Defence Science and Technology Laboratory, UK (Dstl).