Takeda Pharmaceutical has acquired US-based PvP Biologics, which focuses on therapies for coeliac disease, in a deal valued at up to $300m.
The acquisition comes after the completion of Phase I clinical trial of TAK-062 (Kuma062) conducted in patients suffering from uncontrolled coeliac disease.
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Takeda exercised the option to buy PvP Biologics for an upfront payment plus development and regulatory milestones of up to $330m total.
TAK-062 is a super glutenase, a protein that degrades ingested gluten, computationally engineered for the treatment of coeliac disease.
An autoimmune condition, coeliac disease causes inflammation and damage in the small intestine upon ingestion of gluten.
The proof-of-mechanism Phase I trial assessed the safety and tolerability of the drug candidate in healthy volunteers and celiac disease patients. TAK-062’s ability to degrade ingested gluten was studied in healthy participants.
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By GlobalDataTakeda Pharmaceutical Gastroenterology therapeutic area unit head Asit Parikh said: “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 programmes with different modalities that have both demonstrated clinical proof of mechanism.”
TAK-062, designed to enzymatically digest gluten, showed improved catalytic activity compared to other glutenases.
The drug candidate degrades gluten’s immune-reactive parts before them leaving the stomach. This mechanism prevents the immune response to gluten, avoiding disease symptoms and intestinal damage.
Takeda intends to conduct a Phase IIb efficacy and dose-ranging study of TAK-062 in uncontrolled coeliac disease patients on a gluten-free diet.
Previously, the companies signed a development and option agreement for PvP Biologics to conduct research and development through the Phase I study. Under the deal, Takeda funded a development plan.
In October, Takeda licensed coeliac disease candidate from COUR Pharmaceutical Development.
