San Diego’s PvP Biologics has been acquired by Takeda Pharmaceutical Co. Ltd. for up to $330 million after completing an early human trial on a treatment for celiac disease— a severe gluten intolerance that affects about 3 million Americans.
Takeda, which announced the deal Wednesday, was already in a partnership with PvP Biologics, investing $35 million to a Phase 1 study that included healthy volunteers and people with celiac.
The goal was to determine whether the oral treatment, called TAK-062, did a good job eviscerating the bad parts of gluten in acidic conditions found in the human stomach.
The companies had high hopes based on results from lab tests and prior animal studies. While they declined to release specifics of the Phase 1 trial, the results were good enough to be presented at an medical conference.
“What we are saying is that TAK-062 demonstrated robust gluten degradation in people,” said Adam Simpson, chief executive of PvP Biologics. “So we are really happy that the top line proof of mechanism has been established.”
The results also convinced Takeda to pull the trigger on its “build to buy” agreement to acquire PvP Biologics for a pre-negotiated upfront payment, along with additional funds based on hitting regulatory milestones.
“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 Dr. Asit Parikh, head of gastroenterology therapeutics at Takeda. “PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease.”
A genetic disorder, celiac patients can’t digest certain elements of gluten, which is found in wheat and other grains. When these remnants from the stomach to the small intestine, the patient’s immune system attacks, resulting in organ damage, abdominal pain, poor nutrient absorption, fatigue and other ailments.
Of the 3 million people in the U.S. who suffer from the disease, about one third still have symptoms even though they’ve eliminated gluten from their diet, said Simpson.
“A gluten free diet is like decaf coffee — you get less but not none,” he said. “The literature suggest that folks who are on a gluten-free diet are still getting hundreds of milligrams of gluten a day. If you can treat them with a drug like this and avoid the autoimmune cascade, it would be a first-line therapy” for celiac disease.
The engineered, gluten-destroying enzyme was invented at the Institute for Protein Design at University of Washington. PvP obtained an exclusive license in 2016, and it secured non-dilutive funding from Takeda a year later for the Phase 1 study.
Takeda, based in Japan, is planning a Phase 2 trial to further determine effectiveness and optimal dose amounts for people with celiac disease who maintain a gluten-free diet. The company has an office in San Diego, but it is unclear whether the trial will be conducted locally.
Roughly 15 people work at PvP Biologics. While some will be involved in the transition of the celiac treatment to Takeda, the core group likely will begin looking for a new compound to develop, said Simpson. Many of PvP’s team came from Meritage Pharma, which was sold to Shire in 2015 for $245 million.
“The San Diego way is to do exactly what we have done several times, which is find these really innovative technologies, put them together and help them find a home with big companies,” he said.
