Viridax™

The Viridax™ Science Program has provided several key bacteriophage Product Candidates for use as therapeutic products to target specific bacterial infectious agents. Viridax™ has completed the gene sequencing and characterization of the selected Product Candidate bacteriophage.

Viridax™ is developing targeted-effect, tissue-specific and cell-specific drug delivery formulations to enable the bacteriophage active pharmaceutical ingredients (APIs or bacteriophage drug substance active ingredients) to target specific infected tissues and cells. This strategy is especially important in cases where rapid bacterial elimination from specific sites is critical to successful recovery.

The manufacturing and purification development work for the first bacteriophage product candidate has been completed under current Good Manufacturing Practices (cGMP) guidelines of the US Food and Drug Administration (FDA). Formal drug substance and clinical supplies manufacturing will be completed by a Contract Manufacturing Organization (CMO) to provide materials for use in further preclinical studies, stability testing, biodistribution studies and analytical methods development, and for future use in first clinical trials.

Parallel with the scale-up manufacturing and preclinical development testing of the first product for the treatment of Staph infections, Viridax™ continues to develop the Product Candidate bacteriophage further to enhance its spectrum of activity, virulence factors and resistance to host bacterial resistance. These genetically-modified phage are not found in nature.