Three years after Takeda and San Diego-based PvP Biologics inked a $35 million deal to develop a novel treatment for celiac disease, the Japanese pharma company has exercised its option to acquire the company for $330 million.
Three years after Takeda and San Diego-based PvP Biologics inked a $35 million deal to develop a novel treatment for celiac disease, the Japanese pharma company has exercised its option to acquire the company for $330 million.
Takeda and PvP will enter into the agreement following the conclusion of the Phase I trial for TAK-062 (also known as Kuma062), which is being developed for uncontrolled celiac disease. In 2018, PvP initiated its first-in-human clinical studies for Kuma062, a uniquely engineered, recombinant enzyme that is active under acidic stomach conditions and has high specificity for the parts of gluten that cause the autoimmune reaction leading to celiac disease. In its announcement, Takeda said TAK-062 is a potential best-in-class treatment that was computationally engineered to treat celiac disease.
Celiac disease is a genetically driven chronic immune-mediated disorder where abnormal immune responses to gluten peptides lead to inflammation and damage of the small intestine. Currently, the only available treatment for patients with celiac disease is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins, Takeda said.
The acquisition of PvP will enhance Takeda’s commitment to developing treatments for gastrointestinal disorders. TAK-062 represents the second celiac-focused product in the company’s arsenal. In October, Takeda acquired the license for a first-in-class celiac treatment from COUR Pharmaceuticals. TAK-101 is an immune modifying nanoparticle-containing gliadin proteins. The company struck the deal with COUR following positive Phase IIa proof-of-concept. 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.
When the acquisition of PvP is complete, Takeda plans to initiate a Phase IIb efficacy and dose-ranging trial for TAK-062 in celiac patients who maintained a gluten-free diet. The company also plans to submit data from the Phase I safety and tolerability study for presentation at an upcoming medical congress.
Asit Parikh, the head of Takeda’s Gastroenterology Therapeutic Area Unit, noted the difficulty of celiac patients having to maintain that strict diet in order to avoid inflammatory flare-ups from the disorder. Parikh said that TAK-062 has the potential to become a game-changer for these patients.
“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,” Parikh said in a statement.
Adam Simpson, president and chief executive officer of PvP Biologics, said TAK-062 was developed to address the challenges seen by previous glutenases in development for the treatment of celiac disease, particularly their lack of specificity for gluten and activity in the acidic conditions of the stomach. Over the course of its development, TAK-062 demonstrated robust gluten degradation in humans, which was anticipated based on the very potent in vitro profile compared with other glutenases, Simpson said in a statement.
TAK-062 works by enzymatically digesting gluten. It is designed to degrade the immune-reactive parts of gluten before they exit the stomach in order to prevent the immune response to gluten and eliminate the symptoms and intestinal damage caused by celiac disease. The medication has demonstrated enhanced catalytic activity compared to other glutenases, Takeda said.
“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,” Simpson said in a statement.
