Human Health Vision (“HHV”) Biotech B.V., a company developing anti-biofilm drug candidates, announced the successful completion of the GMP manufacturing of its lead drug candidate; HHV-001. Due to a specific purification method that was employed, HHV was able to obtain a larger volume of drug substance than expected, at the desired purity. The amount produced is sufficient to complete pre-clinical activities required to build the IND dossier, as well as to start the human clinical development program. The GMP material is now safely stored in the Netherlands, from where it will be distributed to international partners to continue the pre-clinical development program.

As a next step, the scalability of the production process for clinical and future commercial manufacturing will be evaluated. The successful GMP manufacturing of the API for HHV 001 was conducted by contract manufacturing partner, Thermo Fisher Scientific at its site in Regensburg, Germany.

“Starting early 2021, HHV Biotech approached potential CDMO partners to develop a GMP production process for HHV-001. The composition of our small molecule has proven to be challenging to manufacture. Therefore, we are pleased that our manufacturing partner Thermo Fisher, together with our scientific experts from HHV Biotech, were able to set up a dedicated production processfor this complex molecule, as this is an essential step in our drug development program,” said Kim Bruin, Chief Executive Officer of HHV Biotech. “HHV Biotech is looking forward to continuing its pre-clinical activities, towards developing a new therapy for biofilm related infectious disease.”