INTRAVENOUS PROGRAMME

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Intravenous Programme

Our intravenous programme: MGB Biopharma has successfully formulated, optimised and manufactured a lyophilised formulation of MGB-BP-3

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, have also been completed.

A cGMP clinical batch of MGB-BP-3 API material has been produced and formulated for use in a non-clinical safety intravenous programme.
Preliminary tolerability studies are complete, providing an exciting future opportunity for further development.

MRSA

MRSA: The IV formulation of MGB-BP-3 tested in vitro and in vivo, shows excellent efficacy towards MRSA.

Streptococcal Infection

Streptococcal Infections: IV MGB-BP-3 tested in vitro and in vivo, shows excellent efficacy towards all strains of Streptococcustested, including S. pyogenes and S. pneumoniae.

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