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 prevention rely on periodic colonoscopies and surgical removal of polyps, which are costly, invasive and burdensome for patients. Despite regular surveillance of people with inherited risk, including those with FAP and Lynch syndrome, many still develop cancer.

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Why it matters

Nearly all colorectal cancer begins as a polyp

Polyps are overgrowths of the gut mucosa that accumulate mutations and progress to cancer over years

Surveillance manages risk but never removes it

Decades of repeated colonoscopy: burdensome, costly, and delaying prophylactic colectomy for FAP patients

Removal is the only option, and it is imperfect

Even at best practice, around a quarter of adenomas are missed and recurrence is 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

ULI262 is active in vitro across a 4-log concentration range, indicating a wide potential therapeutic window

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