Japanese drugmaker Takeda Pharmaceutical has acquired PvP Biologics, following the conclusion of a Phase 1 proof-of-mechanism study of TAK-062 (Kuma062), an investigational treatment for uncontrolled celiac disease.

TAK-062 is a potential is a potential best-in-class, highly potent super glutenase – a protein that degrades ingested gluten – which was engineered by computer to treat the serious autoimmune disease. Patients suffering from celiac disease react abnormally to ingesting gluten, which leads to inflammation and damage in the small intestine and can cause abdominal pain, diarrhea, nausea and vomiting.

The acquisition follows an agreement in 2017 when Takeda said it would provide $35 million to PvP for research and development of the therapy, with an exclusive option to acquire the company for an undisclosed fee.

“PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease,” said Asit Parikh, head of Takeda’s gastroenterology therapeutic area unit. “We are now applying our deep expertise in gastrointestinal diseases to advance the clinical study of TAK-062 and TAK-101, two programs with different modalities that have both demonstrated clinical proof of mechanism.”

Takeda is now planning a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet. The company acquired an exclusive license from Cour Pharmaceutical Development last October for TAK-101, an immune modifying nanoparticle designed to induce tolerance to gluten in celiac patients.

PvP Biologics was spun out of the University of Washington in November 2016.