Parabilis在ESMO公布zolucatetide更新I/II期数据，ORR 72.2%但III期要到2029年才读出，消息已发酵且股价先跌

Parabilis Medicines, Inc. (PBLS) announced updated Phase 1/2 data showing that its investigational drug zolucatetide demonstrated encouraging efficacy and a favorable safety and tolerability profile in patients with desmoid tumors. The results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
Zolucatetide is an investigational direct inhibitor of the interaction between ß-catenin and T-cell factor (TCF) transcription factors, a key driver of the Wnt/ß-catenin pathway associated with desmoid tumors and other diseases.
The ongoing Phase 1/2 trial evaluated zolucatetide across dose-escalation and dose-optimization cohorts. Updated results were based on a data cutoff of June 22, 2026, and included 76 patients treated across all dose levels.
According to the company, the key findings include,
- Zolucatetide demonstrated an objective response rate (ORR) of 72.2% (13/18) among response-evaluable patients who began treatment at a starting dose of at least 450 mg in a 32-week landmark analysis.
- A disease control rate (DCR) of 100% was observed across all 46 response-evaluable patients who received a starting dose of at least 450 mg, with no disease progression reported.
- Responses were observed regardless of prior gamma-secretase inhibitor (GSI) exposure or CTNNB1 or APC mutation status, suggesting potential activity across different patient subgroups.
- The selected Phase 3 regimen consists of a 450 mg weekly induction dose for four cycles, followed by 300 mg every two weeks for long-term maintenance.
- Zolucatetide demonstrated a favorable safety and tolerability profile, with treatment-related adverse events (TRAEs) predominantly low-grade. The most commonly reported TRAEs were fatigue, alopecia and nausea.
- No patients discontinued treatment due to TRAEs. The company also reported no association with ovarian toxicity or the high-grade gastrointestinal and skin toxicities commonly reported with GSIs.
Following discussions with the U.S. Food and Drug Administration (FDA), Parabilis said it had aligned with the agency on the selected dose and regimen, a placebo-controlled trial design, and progression-free survival (PFS) as the primary endpoint for registrational development.
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, with further evaluation planned across desmoid tumors and other diseases driven by alterations in the Wnt/ß-catenin pathway.
PBLS has traded between $22.66 and $42.49 over the year.
Currently, PBLS is trading down 9.21% at $24.44.
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October 16, 2026 16:06 ET Monthly consumer price inflation data and retail sales figures were the main news from the U.S. economy this week. In Europe, monthly GDP figures from the U.K. gained attention. External trade data from China was in focus in Asia. Elsewhere, the International Monetary Fund released its latest projections for the global economy.