Parabilis reports strong early zolucatetide activity and FDA-backed Phase 3 plan
On October 24, 2026, Parabilis Medicines released updated Phase 1/2 results for zolucatetide in desmoid tumors. At the 32-week assessment, the objective response rate was 72.2% (13/18) among evaluable patients who started at ≥450 mg, while disease control reached 100% across 46 evaluable patients, with no progression reported. Parabilis said the FDA agreed on the dose, placebo-controlled design and progression-free survival endpoint for PEDESTAL, which the company plans to begin in the first half of 2027 with topline data expected in 2029.
Why it matters
The update gives Parabilis a defined regulatory route toward a pivotal trial and establishes upcoming development milestones for zolucatetide. The efficacy signal remains based on an early-stage study, so the planned Phase 3 trial will be the next major test of the treatment.
Key facts
- 1The Phase 1/2 dataset used a June 22, 2026 cutoff and included 76 treated patients across all dose levels. stocktitan.net
- 2Among patients starting at ≥450 mg, the 32-week objective response rate was 72.2% (13/18), and disease control was 100% among 46 response-evaluable patients. stocktitan.net
- 3The selected dosing plan uses 450 mg weekly for four induction cycles, followed by 300 mg every two weeks for maintenance. rttnews.com
- 4Parabilis plans to start the randomized, double-blind PEDESTAL Phase 3 study in the first half of 2027 and anticipates topline results in 2029. stocktitan.net
- 5The FDA alignment covers the selected dose and regimen, a placebo-controlled study and progression-free survival as the primary endpoint. investing.com
Open questions
- Material 4 alone reports a planned Phase 3 enrollment of 148 patients; the other materials do not provide a trial size.
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.