Key insights
- Parabilis Medicines presented positive Phase 1/2 clinical data for its desmoid tumor drug, zolucatetide, showing a 72.2% objective response rate in evaluable patients. The company has aligned with the FDA on the Phase 3 trial design and endpoints, with the PEDESTAL trial set to begin in the first half of 2027. Zolucatetide has received Fast Track and Orphan Drug designations. These developments suggest strong potential for the drug's approval and commercialization.
Parabilis Medicines (Nasdaq: PBLS) presented updated Phase 1/2 clinical data for its investigational drug zolucatetide in desmoid tumor patients at the European Society for Medical Oncology Congress on Oct. 24, 2026, in Madrid, Spain.
Among response-evaluable patients who began treatment at a starting dose of 450 mg or higher, the drug showed an objective response rate of 72.2% (13 of 18 patients) in a 32-week landmark analysis, based on a June 22, 2026, data cutoff. A disease control rate of 100% was observed across all 46 response-evaluable patients receiving that starting dose, with no disease progression recorded.
As of the data cutoff, 76 patients had been enrolled and treated across all dose levels. Median age was 37 years, and 69.7% of patients were female. Treatment-related adverse events were predominantly low-grade, with fatigue, alopecia, and nausea most commonly reported. No patients discontinued treatment due to treatment-related adverse events.
Data from a three-arm randomized dose optimization trial supported selection of a 450 mg weekly induction regimen for four cycles, followed by 300 mg every two weeks for maintenance. Parabilis said it has reached alignment with the U.S. Food and Drug Administration on the selected dose and regimen, a placebo-controlled study design, and progression-free survival as the primary endpoint.
The company plans to initiate the randomized, double-blind PEDESTAL Phase 3 trial in the first half of 2027, with topline results anticipated in 2029.
Zolucatetide has received Fast Track and Orphan Drug designations from the FDA for the treatment of desmoid tumors. The Phase 1/2 trial is ongoing across desmoid tumors and other tumor types driven by Wnt/β-catenin pathway alterations.
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