Parabilis Medicines Presents Updated Phase 1/2 Data for Zolucatetide Demonstrating Compelling Efficacy and Favorable Safety and Tolerability Profile in Patients with Desmoid Tumors
Key Highlights
- ➤Zolucatetide delivered 72.2% objective response rate at 32 weeks
- ➤Zolucatetide achieved 100% disease control across 46 evaluable patients
- ➤FDA aligned with 450 mg induction and 300 mg maintenance regimen
- ➤PEDESTAL Phase 3 trial planned for first half of 2027
- ➤No treatment discontinuations occurred due to treatment-related adverse events
Expert Statements
Mathai Mammen, Chairman, CEO and President of Parabilis Medicines
“Desmoid tumors are chronic and life-altering for patients, often affecting people at a young age, and patients need treatments that can deliver rapid, deep and durable tumor responses with a tolerability profile suited for long-term treatment.”
Mathai Mammen, Chairman, CEO and President of Parabilis Medicines
“We designed zolucatetide to directly inhibit β-catenin:TCF, a historically undruggable target at the heart of the biology driving these tumors.”
Mathai Mammen, Chairman, CEO and President of Parabilis Medicines
“The depth and consistency of responses we are seeing, together with the favorable safety and tolerability profile observed to date, reinforce our conviction that zolucatetide has the potential to deliver a truly differentiated medicine and meaningfully expand the number of patients who can benefit from treatment.”
Mathai Mammen, Chairman, CEO and President of Parabilis Medicines
“We are very pleased with the clarity of the FDA’s feedback on our registrational development strategy, and with our Phase 3 regimen selected, we are moving with urgency to bring this medicine to patients.”
Mrinal Gounder, Sarcoma Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, and presenting author of the study
“The early clinical results with zolucatetide are encouraging, particularly the magnitude and apparent rapidity of tumor responses observed to date.”
Mrinal Gounder, Sarcoma Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, and presenting author of the study
“Desmoid tumors can impose a substantial physical and emotional burden on patients, and therapies capable of achieving meaningful tumor shrinkage while maintaining acceptable tolerability remain an important clinical goal.”
Mrinal Gounder, Sarcoma Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, and presenting author of the study
“These findings support further investigation of zolucatetide in the planned Phase 3 trial.”
* Objective response rate of 72.2% among response-evaluable patients receiving a starting dose of ≥450 mg at 32-week landmark * Disease control rate of 100% across all response-evaluable patients receiving a starting dose of ≥450 mg, with no disease progression and no treatment discontinuations due to TRAEs * Data informed FDA-aligned dose and regimen selection for upcoming PEDESTAL Phase 3 registrational trial, with initiation planned in the first half of 2027 and topline results anticipated in 2029 * Company to host investor webcast on Saturday, October 24, 2026, at 18:00 CEST (12:00 p.m. EDT) CAMBRIDGE, Mass., Oct. 24, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced updated safety and efficacy data for zolucatetide, the first and only direct inhibitor of the β-catenin:TCF interaction, in patients with desmoid tumors. The data were presented today in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain.
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