The drug candidate at the heart of the deal is TAK-062, which is an engineered enzyme designed to degrade ingested gluten.
Takeda had originally signed a $35m (€32m) agreement with PvP Biologics that included the option to acquire the company outright dependent on clinical trial readouts.
Based on TAK-062’s performance in Phase I trials, Takeda decided to pull the trigger and add the potential treatment for celiac disease to its gastroenterology portfolio for a potential $330m.
Currently, there are no US Food and Drug Administration (FDA) approved treatments for the disease.
PVP Biologics’ drug candidate managed to pass the Phase I hurdle by displaying safety and tolerability in healthy volunteers. Takeda stated that it would make further data from the study available at a future medical congress.
Regarding TAK-062, the companies stated that it has demonstrated catalytic activity beyond current glutenases, which are available as dietary supplements to aid in digestion of gluten.
“TAK-062 demonstrated robust gluten degradation in humans, which was anticipated based on the very potent in vitro profile compared with other glutenases,” said Adam Simpson, CEO of PvP Biologics, on the development of the enzyme.
PVP Biologics designed the potential therapy with software, known as Rosetta Molecule Modeling Suite, in order to create a recombinant enzyme therapeutic that could specifically break down gluten in the stomach before it could cause damage to the intestines.
