MENLO PARK, Calif., Sept. 7, 2012 /PRNewswire/ -- 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."
The complete list of 24 abstracts on KPI-10 to be presented at ICAAC is available on the Kalidex website at www.kalidex.com.
KPI-10 is a novel fluoroquinolone development candidate with a broad spectrum of activity against both gram-positive and gram-negative pathogens, including MDR strains and isolates resistant to currently available fluoroquinolones. KPI-10 is readily distinguished from existing fluoroquinolones because of its potent in vitro activity against gram-positive and gram-negative bacteria that are resistant to the currently-available fluoroquinolones (such as ciprofloxacin, levofloxacin, and moxifloxacin).
KPI-10 is a potent inhibitor of bacterial topoisomerases and is bactericidal. The PK profile of KPI-10 is similar to that of other fluoroquinolones, and as such offers extensive distribution into body tissues and fluids, excellent oral bioavailability, and the possibility of once daily dosing.
KPI-10 has demonstrated an excellent preclinical safety profile as well as a favorable PK and efficacy profile in animal models. KPI-10 is under development in both an IV and an oral formulation, which would enable its use in both the hospital and community settings.
About Kalidex Pharmaceuticals
Kalidex Pharmaceuticals, Inc is a privately held anti-infective company creating the next generation of quinolones to help address the global problem of emerging infections caused by MDR organisms. Kalidex was cofounded in 2010 by Drs. James Ge, Vernocn Jiang and George H. Talbot, along with Frazier Healthcare Ventures. Kalidex's team has a track record of recent successes in the clinical development of antibacterials (gemifloxacin, doripenem, ceftaroline, and CXA-201). In February 2011, the Company raised a $45 million Series A round from six highly respected venture capital firms: Frazier Healthcare Ventures, Domain Associates, Canaan Partners, New Leaf Venture Partners, MPM Capital, and OrbiMed Advisor LLC. In June 2012, Michael R. Dougherty, formerly President and CEO of Adolor Corporation, joined Kalidex as Chief Executive Officer. More information about Kalidex can be found at www.kalidex.com.
Michael R. Dougherty
Chief Executive Officer
Martina Schwarzkopf, Ph.D.
Russo Partners LLC
|SOURCE Kalidex Pharmaceuticals|
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