MGB Biopharma has undertaken extensive formulation work aimed at developing a freeze-dried product which, when reconstituted with aqueous solutions, will show good stability while retaining full efficacy.
Final formulation optimisation and up-scaling has been successfully completed, and pivotal proof of concept and ADME studies assessing IV MGB-BP-3 against Staphylococcus aureus (including MRSA), Streptococcus pyogenes and pneumoniae are complete.
Metabolism studies using radiolabelled MGB-BP-3 to determine metabolite profile and identification, as well as an in vivo study to determine excretion balance and tissue distribution of MGB-BP-3, is now complete.
A cGMP clinical batch of MGB-BP-3 API material has been produced and formulated for use in this non-clinical safety intravenous programme.
Preliminary tolerability studies are ongoing, and we expect formal GLP safety pharmacology and toxicology studies to be initiated in Q1 2017.