Takeda Pharmaceutical has acquired PvP Biologics, a San Diego, California-based pharmaceutical company developing treatments for celiac disease, in a deal worth up to $330 million. The acquisition follows the conclusion of a Phase I proof- of-mechanism study of the investigational medicine, TAK-062, for the treatment of uncontrolled celiac disease.

TAK-062 is a highly potent super glutenase, a protein that degrades ingested gluten – that was computationally engineered to treat celiac disease, am autoimmune disease where the ingestion of gluten leads to inflammation and damage in the small intestine. The Phase I study investigated TAK-062’s safety and tolerability in both healthy volunteers and people with celiac disease. Takeda plans to submit data from the Phase I study for presentation at an upcoming medical congress.

Takeda is planning a Phase IIb efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet. In addition to TAK-062, Takeda previously announced data from a Phase IIa study of TAK-101, a potential first-in-class investigational therapy for the treatment of celiac disease. In the study, TAK-101 demonstrated T-cell response suppression, suggesting that it may induce tolerance to gluten in patients with celiac disease by immune uptake of proprietary nanoparticles loaded with gliadin proteins, a disease-specific antigen.

Takeda exercised its option to acquire PvP Biologics for a pre-negotiated upfront payment as well as development and regulatory milestones totaling up to $330 million. 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 I proof-of-mechanism study of TAK-062 in exchange for funding by Takeda related to a pre-defined development plan.

Source: PVP Biologics