PharmassêtX has received US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for epigallocatechin gallate (EGCG), to treat pouchitis, a rare form of inflammatory bowel disease (IBD).

PharmassêtX’s EGCG, a component of green tea, is being developed as a high-purity, high-potency drug for IBD treatment.

The safety and effectiveness of EGCG for IBD were supported by peer-reviewed studies, including a clinical trial.

A double-blinded, randomised, placebo-controlled, investigator-initiated clinical study of an EGCG-enriched green tea extract demonstrated clinical and endoscopic improvement in patients with mild to moderate ulcerative colitis, without serious adverse events.

Further evidence from a retrospective study showed that most refractory pouchitis patients achieved complete symptom relief with EGCG with no serious adverse events reported.

EGCG’s mechanism of action includes targeting NF-κB, a regulator of mucosal immunity.

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PharmassêtX is working to bring its ultra-pure EGCG drug, PSX-514, into clinical trials.

The company has partnered with Canada-based global contract research organisation Alimentiv to expedite the development of PSX-514 and bring it to clinic in 2025.

PharmassêtX co-founder and CEO Terry Minton stated: “We are grateful to be positioned to provide a much-needed innovative drug, for which there is already substantial evidence of safety and effectiveness, to the underserved community of pouchitis patients.

“Our mission as an organisation is to improve outcomes and enhance quality of life for IBD patients. The granting of this ODD is an important milestone along the critical path to accomplishing that mission.