Takeda acquires PvP Biologics for $330M following Phase I celiac disease study results

Takeda plans to submit data from the study for later presentation and initiate a Phase IIb trial of the drug, TAK-062, in celiac disease patients. In October, it in-licensed another celiac disease drug, COUR Pharmaceuticals’ CNP-101/TAK-101.

One of Japan’s largest drugmakers is acquiring a San Diego-based biotech company with which it was already partnered following results from a Phase I clinical trial in patients with celiac disease.

Osaka-based Takeda Pharmaceutical said Wednesday it would spend $330 million to buy PvP Biologics, following the conclusion of a Phase I proof-of-mechanism study of TAK-062, also known as Kuma062, in healthy volunteers and celiac disease patients. Takeda plans to present data from the trial at an upcoming medical conference. Data from the study were not disclosed.

The drug was created using computational protein design software as part of a project that began at the University of Washington in Seattle, where PvP’s research labs are located. It is a super glutenase, designed to degrade ingested gluten that in patients with celiac disease leads to inflammation and damage in the small intestine. While celiac disease affects at least 3 million people in the U.S., according to the University of Chicago’s Celiac Disease Center, there is no Food and Drug Administration-approved drug therapy to treat it.

“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 of Trakeda’s gastroenterology therapeutic area unit, in a statement. “PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease.”

Takeda plans to initiate a Phase IIb efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet.

PvP started the clinical trial of TAK-062 in September 2018. The company and Takeda had formed the development partnership in January 2017, under which PvP would conduct all the research and development through Phase I, with Takeda providing $35 million in funding in exchange for the exclusive option to acquire the company.

Takeda has been making other moves in celiac disease as well. In October, it acquired a license for another investigational therapy for the drug, COUR Pharmaceuticals’ CNP-101 – now TAK-101 – following the presentation of Phase IIa data. Takeda has an exclusive global license to develop that drug.

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