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4.5 Case Study: Enzyme Therapies Reimagined

Enzyme replacement therapy (ERT) has been one of the
hallmark successes of modern biologics. For patients with
rare metabolic disorders—Gaucher’s disease, Fabry
disease, Pompe, and others—ERTs have transformed what
were once fatal or severely debilitating conditions into
manageable chronic diseases.

But there’s a catch: the system around ERT is breaking.

These therapies are expensive, fragile, and immune-
disruptive. They often require biweekly infusions, cold-
chain logistics, and frequent dose adjustments due to anti-
drug antibodies (ADA). The drugs themselves work—but
the infrastructure needed to deliver them is collapsing
under cost, complexity, and patient fatigue.

This is where edible biologics offer a different way
forward:

Oral enzyme therapies that are grown in plants,
stabilized within their tissues, and delivered directly to
the gut—without the needle, without the clinic, and with
a dramatically reduced immunologic footprint.

The Challenge of Enzyme Replacement Today

Traditional ERTs are administered intravenously, flooding
the bloodstream with the deficient enzyme in hopes that
some fraction reaches the right cells. But this approach
comes with systemic problems:

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