Takeda acquisition of PvP Biologics : Japanese pharma giant Takeda Pharmaceutical Company has acquired US-based celiac disease drug developer PvP Biologics in a deal worth up to $330 million.

The Japanese pharma major exercised its option to acquire the US pharma company following the completion of a phase 1 proof-of-mechanism study of the latter’s investigational celiac disease drug candidate TAK-062 (Kuma062).

The two pharma companies had previously forged a development and option agreement, under which PvP Biologics was to undertake research and development through the phase 1 study of Kuma062. This was in exchange for funding by Takeda Pharmaceutical linked to a pre-defined development plan.

Kuma062 is said to be a highly potent super glutenase, which is a protein that degrades ingested gluten, that was engineered computationally for the treatment of celiac disease.

Considered to be a serious autoimmune disease, celiac disease is a condition in which the ingestion of gluten results in inflammation and damage in the small intestine.

The phase 1 clinical trial of Kuma062 probed the drug candidate’s safety and tolerability in healthy volunteers and also in people with celiac disease.

The ability of Kuma062 to degrade ingested gluten was assessed in healthy volunteers.

Takeda Pharmaceutical intends to submit data from the phase 1 clinical trial of the celiac disease drug candidate for presentation during an upcoming medical congress.

Commenting on Takeda acquisition of PvP Biologics, Asit Parikh – Head, Gastroenterology Therapeutic Area Unit at Takeda Pharmaceutical said: “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.

“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.”

According to the Japanese pharma company, Kuma062 digests gluten enzymatically and has shown improved catalytic activity compared to other glutenases.

The celiac disease drug candidate has been designed to degrade the immune-reactive parts of gluten prior to their exit from the stomach so that it can prevent the immune response to gluten and thereby ease the symptoms and intestinal damage caused by celiac disease.

Takeda Pharmaceutical plans to undertake a phase 2b efficacy and dose-ranging study of Kuma062 in patients having uncontrolled disease and who are on a gluten-free diet.

Adam Simpson – president and CEO of PvP Biologics, commenting on Takeda acquisition of 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 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.”

  Adam Simpson, Asit Parikh, Celiac disease, Japan, Kuma062, PvP Biologics, TAK-062, Takeda Pharmaceutical, USA