Bionomics [ASX: BNO] has completed GMP synthesis of its anxiety drug candidate BNC210, one of the first stages in its preparation for an IND application from the US FDA.
Pharmaceutical manufacturing contractors Sai Advantium completed the Good Manufacturing Practice (GMP) synthesis, and samples they have produced will be used in the final round of toxicological testing before human trials commence.
To successfully complete GMP synthesis all operational methodologies and procedures involved in creating the drug must be demonstrated to perform their intended function.
BNC210 is part of Bionomics' MultiCore technology platform. The company recently announced a major deal with Merck Serono to develop its potassium ion channel inhibitor kvl.3, and is in clinical trials for its vascular disruption agent BNC105.
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