Parabilis Medicines Receives FDA Fast Track Designation for FOG-001 in Desmoid Tumours
Thursday, November 13, 2025
Parabilis Medicines has received Fast Track designation from the United States Food and Drug Administration (FDA) for FOG-001, a first-in-class investigational therapy designed to treat desmoid tumours.
Desmoid tumours are rare, locally invasive soft-tissue growths that can cause pain, reduced mobility, and organ dysfunction. There are currently no approved therapies that directly target the biological mechanisms underlying the disease.
FOG-001 is the first and only direct inhibitor of the β-catenin:TCF interaction, a previously considered “undruggable” target. The therapy is based on Parabilis’s Helicon peptide platform and aims to block the Wnt/β-catenin signalling pathway, which plays a key role in the development of various cancers.
FOG-001 continues to be evaluated in a first-in-human, multicentre, open-label Phase 1/2 study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, and antitumour activity. Further clinical data are expected in 2026.
The designation highlights the significant unmet medical need and recognises the potential of this novel approach to improve outcomes for patients.
The FDA’s Fast Track programme is intended to accelerate the development and review of treatments for serious conditions where current options are limited or inadequate. This designation allows for closer interaction with the FDA and eligibility for accelerated regulatory review pathways, including Rolling and Priority Review.
Early results from an ongoing Phase 1/2 clinical trial have shown promising outcomes. Among patients with desmoid tumours, all response-evaluable participants demonstrated tumour reduction, and an objective response rate of 80 per cent was observed in those with more than one post-baseline scan. The treatment also showed a favourable safety profile, with no severe treatment-related adverse events or discontinuations.
In addition to desmoid tumours, FOG-001 is being studied across a range of Wnt/β-catenin-driven tumour types, including adamantinomatous craniopharyngioma, ameloblastoma, salivary gland cancer, and solid pseudopapillary neoplasm.
The therapy also shows potential for combination use in more complex cancers such as microsatellite-stable colorectal cancer.
Source: parabilismed.com
