Narmafotinib large-scale manufacture complete

Amplia has announced the successful completion its first large-scale manufacturing campaign of narmafotinib, producing approximately 13 kg of active pharmaceutical ingredient (API) to the required purity and quality standards. 

This represents an important milestone in Amplia’s progression towards Phase 3 readiness, marking the successful transition of manufacturing from a research and development setting to a commercial environment. 

The newly manufactured narmafotinib will now be converted into oral capsules for use in ongoing and planned clinical trials. 

Amplia’s Chief Operating Officer, Dr Rhiannon Jones, commented:  

“Amplia continues to develop its manufacturing processes to meet phase-appropriate standards as we move towards a registrational study. This successful large-scale API synthesis campaign is an important step in ensuring we are prepared for the next stages of clinical development.”  

Click to read the ASX release.