PVP Biologics Scores Support from Takeda for Celiac Disease Treatment

Takeda Pharmaceuticals and PvP Biologics have entered into a global agreement to co-develop an enzyme – called KumaMax – designed to help treat patients with celiac disease. The enzyme, which was developed by the biotech startup, helps break down gluten in the stomach to prevent the allergen from triggering an immune reaction and causing damage to the small intestine.

“Takeda’s GI experience and capabilities are a great fit with our goal of developing a novel oral enzyme therapy to make a meaningful impact on the lives of people with celiac disease,” said Adam Simpson, president and CEO of PvP Biologics. “In addition, the significant non-dilutive financing provided by Takeda will accelerate therapeutic development of KumaMax.”

PvP Biologics has agreed to conduct all required research and development through Phase I clinical trials. Takeda will provide $35 million in financing, with the option to acquire the biotech after reviewing the data.

“This agreement with PvP Biologics reinforces Takeda’s commitment to developing therapeutics targeting celiac disease. KumaMax could address a significant unmet need for celiac patients who try, but are unable to completely avoid gluten exposure in their diets, and thus continue to experience debilitating symptoms,” said Asit Parikh, head of the gastroenterology therapeutic area for Takeda. “We are pleased to be partnering with PvP Biologics, a company whose management team has a proven track record of successfully bringing assets that target chronic inflammatory gastrointestinal diseases through development.”

KumaMax is a recombinant enzyme which is currently in preclinical development. Enzymatically active at the low pH found in the stomach, KumaMax specifically targets the parts of the gluten protein that stimulate an autoimmune response. There is no treatment for celiac patients, aside from completely avoiding the allergen by adhering to a limiting gluten-free diet.

“Celiac disease is a disorder in which the ingestion of even a trace amount of gluten can damage the small intestine,” said Dr. Tadataka “Tachi” Yamada, chairman of PvP Biologics. “In pre-clinical experiments, KumaMax has shown the ability to degrade gluten with sufficient efficiency and effectiveness to indicate its exciting potential as an oral therapy for a disease that impairs the lives of millions.”

KumaMax could provide a fail-safe for celiac patients who inadvertently ingest gluten, by degrading the allergen before it can enter the small intestine. This could reduce the painful symptoms and intestinal damage associated with accidental gluten consumption.

Celiac disease affects one percent of the world’s population, according to estimates made by the Celiac Disease Foundation. Celiac disease can progress with exposure to gluten, causing gastrointestinal discomfort, malnutrition and weakness.