SEOUL, South Korea, May 10 CrystalGenomics, Inc., a novel drug R&D company announced today that the Phase I SAD (Single Ascending Dose) study for its novel antibiotic candidate, CG400549, has been successfully completed in Europe.
CG400549 is a potential first-in-class antibiotic candidate targeting ENR (Enoyl-acyl carrier protein reductase, which is a critical enzyme in generating bacterial membrane) as it has novel chemical structure which has never been used as an antibacterial agent previously. CG400549 is being developed to target the notorious resistant bacterial strains including MRSA (Methicillin Resistant Staphylococcus aureus) and VRSA (Vancomycin Resistant Staphylococcus aureus), or commonly referred to as the "super bug." CG400549 has successfully completed the Phase I SAD study in Europe and has just received an approval for its Phase I MAD (Multiple Ascending Dose) study from the Ethics Committee.
The objective of the SAD study was to evaluate safety, tolerability and pharmacokinetic characteristics of CG400549 in healthy volunteers. The study demonstrated that CG400549 was safe and well tolerated among all subjects.
Now that the Ethics Committee has granted an approval for the MAD study, CrystalGenomics plans to initiate the study which will further examine the safety and tolerability profiles of CG400549.
Joong Myung Cho, Ph.D., President & CEO of CrystalGenomics said: "We are very pleased with the SAD study results and this enables us to begin the next Phase I study with a high level of confidence. We anticipate completing the MAD study and will make our transition into Phase IIa clinical trial by the end of this year."
CrystalGenomics, Inc. is a publicly-held company dedicated to the discovery and development of novel drug candidates in the areas of cancer, CNS, inflammation, and infectious diseases. The lead candidate, CG100649 is a next generation NSAID which has completed a Phase IIa trial in Europe and CG200745 for molecular target cancer therapeutics is Phase I ready. The company has competitive and proprietary platform technologies for structural biology, structure-based novel scaffold/lead design, lead optimization and candidate selection. CrystalGenomics is headquartered in Seoul, Korea and its subsidiary, CG Pharmaceuticals Inc., is located in Emeryville, California for US and EU clinical management. For more information on CrystalGenomics, please visit: www.cgxinc.com
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SOURCE CrystalGenomics, Inc.