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Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.
Takeda announced on Feb. 26, 2020 that it has acquired PvP Biologics, a San Diego, CA-based biologics company, after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease, a chronic immune-mediated disorder.
According to a Takeda press release, Takeda will acquire PvP for a pre-negotiated upfront payment along with development and regulatory milestones for up to $330 million. This acquisition follows the establishment of a development and option agreement between the companies where PvP was in charge of research and development through the Phase 1 study of TAK-062 in return for funding from Takeda.
The drug works to enzymatically digest gluten by degrading the immune-reactive parts of gluten before they leave the stomach to prevent the immune response to gluten and eliminate the symptoms and intestinal damage triggered by celiac disease, the press release said. Takeda is currently organizing a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with uncontrolled celiac disease who sustain a gluten-free diet.
“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 MD, PhD, head, Gastroenterology Therapeutic Area Unit at Takeda, in the press release. “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.”
“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,” added Adam Simpson, president and CEO of PvP Biologics, in the press release. “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.”