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These results validated the hypothesis that edible, plant-
based GCase could functionally replace traditional
intravenous enzyme replacement therapy (ERT) in
preclinical models.

Clinical Translation: PRX-112 Enters Human Trials

Protalix’s PRX-112—an orally delivered, plant cell-
expressed form of GCase—has moved beyond proof-of-
concept:

• Phase I clinical trial results (NCT01956903)
demonstrated safety and tolerability in healthy
volunteers, with dose-dependent pharmacokinetics
and no serious adverse events.
• A Phase IIa study followed, investigating multiple
dosing regimens over 28 days. While full efficacy
results are pending, the therapy showed absorption
and activity signals without triggering ADA
formation.
— [Source: Protalix BioTherapeutics press
releases, 2016–2017]

Though not yet approved, this represents a significant step
toward human validation of orally delivered GCase—a
milestone with implications for the entire class of edible
enzyme therapies.

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