Toleranzia AB (publ) announced that it has finalized the development of an optimized drug product formulation of its drug candidate TOL2. The new formulation, which comprises a freeze-dried TOL2 drug product with excellent characteristics, can be stored with extensive stability and reconstituted at a high active drug concentration. The formulation development program, initiated earlier this year, was based on material from the technical batch produced at 3P Biopharmaceuticals during late spring and has included extensive testing of different conditions to optimize TOL2 drug product characteristics.

Multiple parameters such as pH, ionic strength, buffers, excipients, and concentrations of TOL2 have been varied in either a frozen or a freeze-dried format to obtain a final drug product with optimized properties for storage, reconstitution, and stability. The work has been completed by Toleranzia's Danish partners Bioneer and CMC Assist with excellent results. The final formulated drug product comprises a freeze-dries TOL2 that can be stably stored and reconstituted at an high concentration of active drug.

The long-term stability is currently being investigated to determine the drug product shelf life, which is expected to be at least two years - fully sufficient for the clinical program. In addition to this, freeze-dried TOL 2 drug product has successfully been prepared from the technical batch, to be used in the GLP-toxicology study at Charles River Laboratories in France starting in mid-September.