CrystalGenomics receives draft CSR for CG400549 Phase I MAD study in Staph infections

CrystalGenomics, Inc., a biopharmaceutical company with 3 clinical stage candidates, has announced today that the draft Clinical Study Report (CSR) from CG400549's Phase I Multiple Ascending Dose (MAD) Study has just been received.

CG400549 is a potential first-in-class antibiotic candidate targeting the fatty acid biosynthesis enzyme FabI, a critical enzyme in generating bacterial membrane and has a novel chemical structure which has never been used as an antibacterial agent previously. CG400549 is being developed to target the notorious resistant bacterial strains such as MRSA (Methicillin Resistant Staphylococcus aureus) and VRSA (Vancomycin Resistant Staphylococcus aureus). CG400549 had successfully completed the Phase I Single Ascending Dose Study in Europe last year and has just received the draft CSR for the Phase I MAD study.

The objective of the MAD study was to evaluate safety, tolerability and pharmacokinetic characteristics of multiple ascending doses of CG400549 in healthy volunteers and a Phase IIa proof-of-concept study is anticipated to initiate as soon as the CSR is finalized.  

CG400549 has displayed remarkable in vitro and in vivo efficacy against some of the gold standard "superbug" therapeutics including Zyvox® and vancomycin as it demonstrated 4 to 8 fold better MICs, respectively. Prior to initiating clinical studies, several in vitro efficacy experiments were conducted at the laboratories of prominent infectious disease clinicians including Dr. Peter Applebaum's lab at the Hershey Medical Center.

Antibacterial resistance is a serious global health issue and one of the main culprits is the infections caused by Staphylococcus aureus such as MRSA. The number of MRSA infections in the United States has been increasing significantly as a 2007 report in Emerging Infectious Diseases, a publication of the Centers for Disease Control and Prevention (CDC), estimated the number of MRSA infections in hospitals doubled nationwide, from approximately 127,000 in 1999 to 278,000 in 2005, while at the same time annual deaths increased from 11,000 to more than 17,000. This is why there has been and will continue to be, a steady demand for novel class of antibiotics such as CG400549.

CrystalGenomics' dedication in combating infectious diseases has been evident in a number of occasions including its recent accomplishment of solving the 3 dimensional structure of the New Delhi metallo-beta-lactamase-1 (NDM-1), an enzyme that makes bacteria resistant to a broad range of beta-lactam antibiotics which recently resurfaced in India and multiple countries worldwide. Also, in addition to CG400549 program, CrystalGenomics has several active discovery programs in infectious disease area. CrystalGenomics' capability in discovery and development of anti-infective drugs has been validated last year when it announced that it had entered into an R&D collaboration with AstraZeneca for novel anti-infectives.