UPDATE : Wednesday, October 16, 2019
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Crystal Genomics signs accord with CRO firm
  • By Lee Han-soo
  • Published 2019.08.06 17:20
  • Updated 2019.08.06 17:20
  • comments 0

Crystal Genomics said that it has signed an agreement with PRA Health Science, a contract research organization, to conduct clinical trials into CG-549, an antibiotics candidate against super bacteria.

Under the accord, PRA will conduct a bridge study on changing the formulation of CG-549 from a capsule-form to a tablet-form.

PRA plans to conduct the study in Europe to determine the optimal dose and follow-up with separate phase 2 clinical trial in the U.S.

The company’s CG-549 is a new class of antibiotics that have never been used as antibiotics and has indications for the most common lethal super-bacteria, MRSA (methacycline-resistant staphylococcus aureus) and VRSA (vancomycin-resistant staphylococcus aureus).

CrystalGenomics finished conducting a phase-1 trial on CG-549 and completed a phase-2a study in the U.S. in 2018. CG-549 showed a 91 percent cure rate in MRSA infected patients within three days and a 100 percent cure for all patients within two weeks.

Despite this excellent effect, low bioavailability of the drug made it difficult to take as the patients needed to take six pills at once. To solve such issues, the company developed a tablet form of the drug that can improve the bioavailability of the drug and reduce the dosage to one or two tablets.

Also, Crystal Genomics has completed the development of a process that significantly reduces manufacturing cost by simplifying the manufacturing process as well as reducing the size of the formulation compared to the conventional capsule formulations.

“We will do our best to get the results of CG-549 quickly by utilizing PRA's various global clinical experience and networks in the U.S. and Europe,” a company official said.

corea022@docdocdoc.co.kr

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