Promising Treatment for Celiac Disease Draws Attention from Takeda

PvP Biologics has been acquired by Takeda Pharmaceutical, a Japanese multinational pharmaceutical and biopharmaceutical company, following the conclusion of the Phase 1 proof-of-mechanism study of TAK-062. This is an investigational medicine for the treatment of uncontrolled celiac disease.

“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 Dr. Asit Parikh, head, Gastroenterology Therapeutic Area Unit at Takeda.

The TAK-062 digests gluten enzymatically and has shown an enhanced catalytic activity in comparison to other glutenases. This is designed to degrade the immune-reactive parts of gluten before they leave the stomach and eliminate the immune response to gluten, preventing the symptoms caused by celiac disease.

“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.”

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Next steps involve planning a Phase IIb efficacy and dose-ranging study of TAK-062 in patients with uncontrolled celiac disease who also maintain a gluten-free diet.

Takeda and PvP Biologics’s previously entered into a development and option agreement that entailed PvP Biologics being responsible for conducting the research and development through Phase 1 proof-of-mechanism study, whilst Takeda offered the funding. 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.

“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,” said Adam Simpson, president and chief executive officer of PvP Biologics. “Takeda has been a great partner and has the expertise, resources, and commitment to people living with celiac disease required to lead the next stage of TAK-062 development.”