The problem

No drug for colorectal cancer prevention

Curileum discovered and is developing a novel, oral small molecule drug that addresses the root cause of colorectal cancer: mutations leading to abnormal cell production forming polyps and progressing to cancer.

Colorectal cancer is one of the most common and deadly cancers worldwide. Current strategies for colorectal cancer prevention rely on periodic colonoscopies and surgical removal of polyps, which are costly, invasive and burdensome for patients. Despite screening programmes for conditions such as FAP and Lynch syndrome, many high-risk individuals still develop cancer.

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The problem

All colorectal cancer develops from polyps

Polyps are overgrowths of gut mucosa that can develop mutations leading to cancer

Surveillance is inefficient and costly

Bowel screening programs use a home FIT test every two years after age 60, with limited colonoscopy uptake and costs ranging from $1,000 to $3,000

No drug to reduce polyps and risk of cancer

Colonoscopy and polyp removal are the standard of care — yet up to 25% of polyps are missed, and colorectal cancer recurrence remains common

Our solution

ULI262 – a first-in-class colorectal cancer therapy drug

Our novel pan-PPAR agonist addresses these large, unmet needs in colorectal cancer prevention. ULI262 provides a new treatment for patients with FAP, high-risk individuals identified in screening programmes like those with Lynch syndrome, and patients who remain at an elevated risk of relapse after treatment.

By re-directing precancerous cells toward normal tissue, ULI262 may prevent progression to cancer – offering the first scalable, non-invasive pharmacological solution for colorectal cancer prevention. 

Curileum is currently preparing for first-in-human clinical studies of ULI262 for FAP treatment. We expect the FDA will grant Orphan Drug Designation for the treatment of FAP, helping to expedite the clinical trial process and accelerate the timeline to treating patients in urgent need. 

Why ULI262

Properties and advantages of ULI262

Safe and efficacious

In a highly relevant in vivo model of FAP, ULI262 safely eliminates >99% of polyps after 3 months of daily oral treatment

Dual action properties

ULI262’s dual action properties distinguish it from other agents by eliminating polyps while exerting a powerful anti-inflammatory effect

Wide potential therapeutic range

in vitro activity demonstrated over a 4-log range

Delivered as oral pill

ULI262 delivered as an oral pill makes it a highly desirable treatment for patients and a cost-effective solution for healthcare systems

Non-surgical treatment

ULI262 elimination of polyps will allow FAP patients to remain under surveillance and potentially obviate colectomy