PvP Biologics begins 1st in-human celiac disease trials — 4 insights

PvP Biologics is conducting the first in-human clinical trials for its celiac disease drug candidate Kuma062.

Here's what you should know:

1. PvP is testing Kuma062 in 80 adults at two U.S.-based sites. The therapy consists of a recombinant enzyme that targets the reaction-causing parts of gluten.

If celiac disease sufferers ingest gluten, Kuma062 will degrade the immune reactive gluten molecules before they reach the stomach, decreasing the likelihood of an immune response.

2. The trial is enrolling normal volunteers at Ann Arbor-based Michigan Medicine and at a site in Anaheim, Calif. The Anaheim site is also enrolling patients with biopsy-confirmed celiac disease, who maintain a strict gluten-free diet.

3. Following the phase 1 proof-of-principle studies, Takeda can acquire Kuma062.

4. PvP Biologics Chief Development Officer Malcolm Hill, PharmD, said, "We believe this could be a first-in-class novel oral enzyme therapy that could address a significant unmet medical need for people with celiac disease."

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