Takeda acquires PvP Biologics after successful Phase 1 study of Celiac Disease treatment
pharmafile | February 26, 2020 | News story | Research and Development | Celiac, PvP, Takeda, phase 1, phase III
Takeda has acquired PvP Biologics following the conclusion of a Phase 1 study of the investigational medicine TAK-062 for the treatment of Celiac disease.
The Phase 1 study investigated TAK-062’s safety and tolerability in both healthy volunteers and people with the disease. The ability of the treatment to degrade ingested gluten was studied in healthy volunteers.
Dr Asit Parikh, Gastroenterology Therapeutic Area Unit at Takeda, at PvP, 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.”
TAK-062 enzymatically digests gluten and has demonstrated enhanced catalytic compared to other glutenases. 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.
Takeda exercised its option to acquire PvP Biologics for a pre-negotiated upfront payment as well as development and regulatory milestones totalling up to $330 million. The company are currently planning a Phase 2b efficacy and a dose-ranging study of TAK-062 in patients with uncontrolled.
Celiac disease affects 1% of America and 0.5% of the world. It can cause abdominal pain, diarrhea, nausea and vomiting with long term complications including malnutrition accelerated osteoporosis and problems related to production.
Conor Kavanagh
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