Takeda has acquired PvP Biologics for $330 million following the conclusion of a Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.
 
Takeda and PvP Biologics previously entered into a development and option agreement, under which PvP Biologics was responsible for conducting research and development through the Phase 1 proof-of-mechanism study of TAK-062 in exchange for funding by Takeda related to a pre-defined development plan.
 
TAK-062 is a potential best-in-class, highly potent super glutenase—a protein that degrades ingested gluten—that was computationally engineered to treat celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage in the small intestine. The Phase 1 study investigated TAK-062’s safety and tolerability in both healthy volunteers and people with celiac disease. The ability of TAK-062 to degrade ingested gluten was studied in healthy volunteers. Takeda plans to submit data from the Phase 1 study for presentation at an upcoming medical congress.
 
“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,” said Asit Parikh, head, gastroenterology therapeutic area unit, Takeda. “PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease. 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.”
 
Adam Simpson, president and chief executive officer, PvP Biologics,” 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. As a result, TAK-062 demonstrated robust gluten degradation in humans, which was anticipated based on the very potent in vitro profile compared with other glutenases.”
 
Takeda is planning a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet.