PvP Biologics has been acquired following the conclusion of Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062), which is being developed to treat uncontrolled celiac disease.
The TAK-062 is a potent super glutenase protein, which degrades ingested gluten. It was computationally designed for the treatment of celiac disease, a serious autoimmune disease.
PvP Biologics president and CEO Adam Simpson said: “TAK-062 was engineered in 2015 to address the challenges seen by previous glutenases in development for the treatment of celiac disease – their lack of specificity for gluten and activity in the acidic conditions of the stomach.”
The Japanese firm exercised its option to purchase PvP Biologics for a pre-negotiated upfront payment and development and regulatory milestones of up to $330m.
Earlier, both firms signed a development and option agreement to enable PvP Biologics to conduct research and development via Phase 1 proof-of-mechanism study of TAK-062 in exchange for funding by Takeda related to a pre-defined development plan.
The TAK-062, which enzymatically digests gluten, has shown enhanced catalytic activity compared to other glutenases.
It will degrade the immune-reactive parts of gluten before they exit the stomach, helping to avoid the immune response to gluten and eliminate the symptoms and intestinal damage caused by celiac disease
The Phase 1 study evaluated the safety and tolerability of TAK-062 in both healthy volunteers and people with celiac disease. Its capacity to degrade ingested gluten was assessed in healthy volunteers.
Takeda aims to start a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with the uncontrolled disease who maintain a gluten-free diet.
Takeda therapeutic area unit gastroenterology head Dr Asit Parikh said: “Many people living with celiac disease manage their symptoms by following a gluten-free diet, but there is no treatment for those who continue to experience severe symptoms.
“PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease.”
In November 2019, Takeda Pharmaceutical opened a new dengue vaccine manufacturing facility in Singen, Germany.