Takeda Pharmaceutical Company Limited and PvP Biologics, Inc have announced a global agreement for development of Kumamax, a novel enzyme designed to break down the immune-reactive parts of gluten in the stomach, thereby avoiding the painful symptoms and damage done in the small intestine from accidental gluten ingestion.
Under terms of agreement, PvP will conduct research, development through phase 1 proof-of-principle studies and Takeda will fund $35 million for PvP’s expenses related to the plan in exchange for an exclusive option to acquire PvP following receipt of a pre-defined data package. “Takeda’s GI experience and capabilities are a great fit with our goal of developing a novel oral enzyme therapy to make a meaningful impact on the lives of people with celiac disease,” Adam Simpson, president and CEO of PvP Biologics, said in a statement.
A gluten-free diet is costly and challenging even if goverments of different countries are trying to protecting and helping people with celiac disease and those who must eat a gluten-free diet with policies varying from country to country ( check here the diffierent policies around the World). It is estimated that celiac disease affects 1 in 100 people worldwide.
The development of PvP Biologics’s enzyme that can be taken orally and survive in the harsh acidic environment of the stomach, called KumaMax, can be a great help for those cannot completely avoid gluten exposure:
“KumaMax could address a significant unmet need for celiac patients who try, but are unable to completely avoid gluten exposure in their diets, and thus continue to experience debilitating symptoms,” Asit Parikh, head of the gastroenterology therapeutic area for Takeda. Upon PvP’s successful completion of the development plan, Takeda may exercise its option to acquire PvP by paying an undisclosed fee as well as development and regulatory milestones.
Source: Reuters, Press Release, Celiac Disease Foundation