Crystal Genomics said that it has completed the phase 1 clinical trial for CG-549, a new drug candidate for an antibiotic that removes super bacteria, in the Netherlands.
CG-549 is a new concept antibiotic drug candidate under development for treating various forms of super bacteria, such as methicillin-resistant staphylococcus aureus (MRSA) and vancomycin-intermediate staphylococcus aureus (VRSA).
The company conducted the clinical trial to change the formulation of the CG-549 from a capsule form into a tablet, evaluating the clinical pharmacokinetics (PK), tolerability, and safety of the oral tablet in 24 healthy adult men and women.
As an oral capsule, the company has long confirmed the drug's safety and effectiveness through various clinical trials in Europe and the U.S. Notably, in patients with MRSA infection, the drug was able to cure 91 percent of patients within three days and all of the patients within two weeks.
However, the company decided to change the drug's formulation after confirming that the CG-549 capsule formulation had limited bioavailability. Patients had to take at least six capsules at once to see efficacy. It made the company conclude that the drug's capsule formulation would be difficult for commercialization and settled on working on a tablet design that shows the same efficacy with one or two tablets.
"Through a formulation improvement study, we developed a tablet that improved the patient's compliance and bioavailability of CG-549 by significantly reducing the pill's dosage and size," a company official said.
As the drug has shown high efficacy in the U.S phase 2 clinical trial as a capsule model, the company expects to produce similar results in the tablet formulation, he added.
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