Kalidex Pharmaceuticals, a privately-held anti-infective company, today announced the presentation of data on its lead development candidate KPI-10, a broad spectrum, next-generation fluoroquinolone, at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, September 9 through 12.
The data describe the in vitro and in vivo activity of KPI-10 against a wide range of important gram-negative and gram-positive pathogens, including multi-drug resistant (MDR) strains and isolates resistant to currently available fluoroquinolones. The company will also present initial Phase 1 study data, which showed that in healthy volunteers single ascending doses of oral KPI-10 were generally safe and well-tolerated and that the pharmacokinetic (PK) profile may support once-daily oral dosing.
"Resistance to currently available antibiotics is increasing worldwide, and new treatment options are needed," said Michael R. Dougherty, chief executive officer of Kalidex. "Due to their broad spectrum and favorable PK profile, fluoroquinolones have long been regarded as workhorse antibiotics in the treatment of a wide range of community and hospital-acquired bacterial infections. However, the emergence of resistance is now limiting their clinical utility for treatment of certain important infections. KPI-10 is a potent fluoroquinolone with a broad and balanced spectrum of activity, and is a very promising development candidate for treating these challenging infections."
A total of 24 posters on KPI-10 will be presented at the conference. Of these, eleven demonstrate the potent in vitro and in vivo activity of KPI-10 against a wide variety of important contemporary gram-positive and gram-negative pathogens, such as staphylococci, Streptococcus pneumonia, Escherichia coli, Acinetobacter spp., and Neisseria gonorrhoeae, including MDR and fluoroquinolone-resistant strains.
In addition, James Ge, M.D., Ph.D., president and chief scientific officer of Kalidex will deliver an oral presentation at the Poster Summary Session on Early New Antimicrobial Agents at 1:45 p.m. PDT on Sunday, September 9. The data to be presented reflect the substantial progress made at Kalidex on KPI-10 since the company's inception approximately 18 months ago, and cover a wide range of preclinical efficacy, PK, and toxicology data, as well as initial Phase 1 clinical data.
"The profile of KPI-10, particularly its activity against MDR strains of E. coli, N. gonorrhoeae, Acinetobacter species, streptococci and MRSA, suggests that successful development of this drug candidate may offer physicians a valuable treatment option," said Dr. Ge. "Furthermore, our development of intravenous (IV) and oral formulations of KPI-10 is intended to allow for an IV-to-oral step down option, which is very desirable in today's healthcare settings. We look forward to completing Phase 1 clinical evaluation of KPI-10, and anticipate beginning our Phase 2 program in mid-2013."