Parabilis Launches Dose-Ranging Study for FAP Treatment
News related to:Parabilis Medicines · 2 min read
CAMBRIDGE, Mass., Oct. 14, 2026 /CourierPR/ -- Parabilis Medicines, a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, has initiated a dose-ranging clinical study of zolucatetide in patients with familial adenomatous polyposis (FAP). The study is part of the company’s ongoing Phase 1/2 clinical trial, which is evaluating zolucatetide across Wnt/β-catenin-driven diseases. The initiation of this dose-ranging cohort reflects the company’s growing confidence in zolucatetide’s potential to fundamentally change the treatment of FAP and is an important step toward defining the dose and schedule for registrational development for this devastating disease.
Zolucatetide, Parabilis’ lead investigational Helicon™ peptide and the first and only direct inhibitor of the β-catenin:TCF interaction, is designed to address the underlying biology of FAP. FAP is a genetic disease caused by germline loss-of-function mutations in the APC gene, resulting in persistent activation of Wnt/β-catenin signaling that drives the development of hundreds to thousands of precancerous gastrointestinal polyps. Without intervention, people with FAP face the near certainty of developing colorectal cancer. Prophylactic colectomy is often required to reduce that risk, but even after removal of the colon, patients remain at risk of developing precancerous polyps and cancer elsewhere in the gastrointestinal tract, particularly in the duodenum, as well as other manifestations of FAP.
Early clinical proof-of-concept data reported to date from patients with FAP and concomitant desmoid tumors enrolled in the ongoing Phase 1/2 trial support the therapeutic potential of zolucatetide in FAP. In two patients who underwent routine endoscopic evaluation while receiving zolucatetide, significant reductions in polyp burden were observed, from Spigelman Stage IV to a near-normal duodenum and from Spigelman Stage II to Stage I, respectively. Zolucatetide has demonstrated a favorable safety and tolerability profile to date.
The dedicated FAP cohort is part of Parabilis’ ongoing Phase 1/2 clinical trial of zolucatetide, a multicenter, open-label study evaluating zolucatetide across Wnt/β-catenin-driven diseases. The cohort will evaluate zolucatetide monotherapy in adults with FAP and a documented APC mutation who have undergone colectomy and have measurable duodenal polyp burden.
Parabilis anticipates disclosing additional data in the first quarter of 2027 from patients with FAP and concomitant desmoid tumors currently enrolled in the ongoing Phase 1/2 trial.
Beyond FAP, zolucatetide is being evaluated across a broad range of Wnt/β-catenin-driven tumor types, including desmoid tumors, adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC), and multiple other tumor indications.
Zolucatetide is currently being evaluated in an ongoing Phase 1/2 clinical trial (NCT05919264) across a range of indications, including desmoid tumors, familial adenomatous polyposis (FAP)