US-based biopharmaceutical company FogPharma has dosed the first patient in its first-in-human Phase I/II clinical trial of FOG-001, a TCF-blocking β-catenin inhibitor intended to treat colorectal cancer (CRC).
The trial will be carried out as a non-randomised, open-label, multicentre, dose escalation and dose expansion study.
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It will assess FOG-001’s pharmacokinetics, pharmacodynamics, safety, tolerability and antitumour activity.
Up to 200 patients with Wnt/β-catenin signaling, pathway-activated advanced or metastatic solid tumours will be enrolled in the trial, with an initial focus on CRC.
Phase I of the trial will enrol 60 subjects for evaluating FOG-001’s tolerability and safety, as well as determining a recommended Phase II dose.
The Phase II portion intends to enrol up to 140 patients and will further characterise the drug’s tolerability, safety and anti-tumour activity at the recommended Phase II dose.
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By GlobalDataFogPharma’s incoming chairman, president and CEO Mathai Mammen said: “FOG-001 has the potential to become a significant new treatment option for the large number of cancer patients whose disease is driven by derangement of the Wnt/β-catenin pathway, including those with colorectal cancer.
“Metastatic colorectal cancer is a devastating malignancy with increasing prevalence and few approved therapies directly targeting oncogenic driver mutations.
“These patients are in need of novel therapeutic options. We look forward to characterising the safety, tolerability and anti-tumour activity of FOG-001 in this Phase I/II trial.”
In biochemical and cellular studies, FOG-001 has demonstrated that it can disrupt the interaction of β-catenin potently and selectively with TCF.
Preclinical studies have shown the drug can cause tumour growth inhibition and complete regression by disrupting β-catenin-dependent signalling.
Based in Cambridge, Massachusetts, FogPharma aims to address the limitations of existing drug classes and achieve ‘universal druggability’ with its proprietary Helicon therapeutics.
The company has raised more than $360m from life sciences investors to date, having completed a $178m Series D financing round last year.
