Parabilis starts dose-ranging FAP study of zolucatetide

Parabilis Medicines (Nasdaq: PBLS) announced Oct. 14, 2026, the initiation of a dose-ranging clinical cohort evaluating zolucatetide in patients with familial adenomatous polyposis (FAP), as part of its ongoing Phase 1/2 clinical trial.

The dedicated FAP cohort will evaluate zolucatetide monotherapy in adults with FAP who have a documented APC mutation, have undergone colectomy, and have measurable duodenal polyp burden. The broader Phase 1/2 trial is a multicenter, open-label study assessing zolucatetide across Wnt/β-catenin-driven diseases.

Parabilis cited early clinical data from two FAP patients with concomitant desmoid tumors who underwent routine endoscopic evaluation while receiving zolucatetide. One patient showed a reduction in polyp burden from Spigelman Stage IV to a near-normal duodenum, and a second showed a reduction from Spigelman Stage II to Stage I. The company said zolucatetide has demonstrated a favorable safety and tolerability profile to date.

Zolucatetide is described by the company as an investigational direct inhibitor of the β-catenin:TCF interaction, targeting the APC-mutation biology that drives precancerous polyp formation in FAP patients. FAP currently has no approved systemic therapies.

Parabilis said it anticipates disclosing additional data from FAP patients with concomitant desmoid tumors in the first quarter of 2027. The company also stated that a Phase 3 registrational trial in desmoid tumors is planned.

Beyond FAP, zolucatetide is being evaluated in desmoid tumors, adamantinomatous craniopharyngioma, hepatocellular carcinoma, and other Wnt-driven tumor types.

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