Check-Cap Ltd., of Isfiya, Israel, reported positive results from a U.S. pilot study of its C-Scan System, a preparation-free, ingestible scanning capsule-based technology aimed at preventing colorectal cancer (CRC) through early detection of precancerous polyps. The company is currently preparing an IDE submission with the U.S. FDA and plans to launch a pivotal clinical trial in late 2020.

Colon cancer is the third most common cancer diagnosed in the U.S. and the second leading cause of cancer death. This year alone saw more than 101,000 new cases diagnosed, according to the American Cancer Society. But while colonoscopy is the gold standard for colon cancer screening, many people forego the procedure because of the mandatory bowel cleanse that precedes it.

“If you look at the population in the U.S., the eligible population complying [with federal colon screening guidelines] is about 60%, meaning that 40% of the population doesn’t comply,” Alex Ovadia, Check-Cap’s CEO, told BioWorld MedTech. “That’s tens of millions of people who do not get a screening.”

C-Scan employs a swallowable capsule and low-dose X-ray to scan the colon as it passes through the gastrointestinal tract over the course of several days. The information is transmitted to a tracking system attached to the patient’s back and then downloaded into a workstation for analysis by a technician and physician. If the test reveals precancerous polyps, the patient will be referred for a colonoscopy and resection of the worrisome growths. No information is retained in the capsule.

Good safety, compliance profile

The prospective, multicenter, open-label, single-arm pilot study assessed C-Scan’s safety and usability, as well as patient compliance, in 28 patients, more than two-thirds who were deemed of average risk for CRC. In addition to ingesting the pill, all of the patients underwent a fecal immunochemical test (FIT) and comparative colonoscopy. The study met its primary safety endpoint, with no serious adverse events reported. The method also demonstrated strong patient compliance and satisfaction and device- and procedure-related performance.

“The results of the study are promising, both in terms of safety and patient compliance of the procedure,” said Seth Gross, a gastroenterologist and assistant professor of medicine at NYU Langone Health and principal investigator in the study. “Most noninvasive colorectal cancer screening options currently available have modest efficacy detecting precancerous polyps. We are excited at the potential of the C-Scan System offering a patient-friendly screening option that could detect precancerous polyps before they become malignant.”

The pilot study also aligns with results of a post-CE mark approval study showing agreement between C-Scan and colonoscopy in the detection of precancerous polyps. Check-Cap earned the CE mark for its ingestible pill in early 2018, followed by approval in Israel later that year.

EU, Israeli approvals

Check-Cap has yet to commercialize its product in either market, choosing to focus its resources on obtaining U.S. regulatory approval and the stateside launch of C-Scan. The company is currently in talks with the FDA about the design of its pivotal trial, which it hopes to get underway late next year, and which will use a new version of the C-Scan system. “We’re looking for a 510(k) de novo process,” Ovadia said, adding that the trial will be close in size to Medtronic’s Pill-Cam study, which evaluated that device in about 700 patients.

The company is also working to ensure widespread access to C-Scan once it is approved. “We would like the [IDE] submission to include, as much as possible, any of the strategy pieces that we have on reimbursement so that once the device receives FDA approval, it will be much easier to get reimbursement in the U.S.,” he said.

If all goes well, Check-Cap is looking to roll out its C-Scan system in 2022. Meanwhile, limited pilot launches are planned in Israel and Europe in 2020 and 2021, respectively.

Wall Street gave the company a thumbs up following news of the pilot results. “We continue to feel that Check-Cap is differentiated as it offers a patient-friendly preparation-free option to detect precancerous polyps in the colon, which could improve patient compliance and lead to better long-term outcomes for patients,” wrote H.C. Wainwright & Co. analyst Yi Chen. With a U.S. pivotal trial on the horizon, Wainwright reiterated its buy rating and target price of $15 per share.

In a research note posted earlier this month, Jason Kolbert, of Dawson James Securities, predicted that “an ingestible capsule with no prep could be paradigm-shifting and drive increased adoption in the $2B colorectal screening market.” Kolbert added that the positive results from the European study suggest “super-pill is comparable in terms of detection” to standard colonoscopy.

Looking at capital raise in 2020

Founded in 2004, Check-Cap has raised a total of about $95 million to date, the latest in a $4.75 million private placement earlier this month. Ovadia said the company is hoping to raise an additional $30 million in the coming year to support the U.S. pivotal trial and general operations. It is also considering a strategic partnership.

Publicly traded on Nasdaq since 2015, Check-Cap reported $11.5 million in cash at the close of the 2019 third quarter, ended Sept. 30 – roughly equivalent to one year of operating capital.

“We do not intend to replace colonoscopy. We offer an alternative, an alternative that has huge advantages,” Ovadia said.

He noted, for instance, that among the current screening options, FIT and Exact Sciences Corp.’s Cologuard have low sensitivity for precancerous polyps. These and biopsy are focused on detection of cancer after the fact. “Biomarkers are more likely to identify cancer and less likely to identify precancerous polyps, which is exactly what we are bringing to the table,” he said. “When you detect a precancerous polyp, you are more likely to keep the patient healthy and not identify a cancer, which is a too-late situation.”

Currently, Check-Cap is not aiming for cancer detection, but that may change in the future. While C-Scan shows less sensitivity for cancer than for precancerous polyps, “our technology has the potential to even identify cancer,” Ovadia said.

In time, and as capital allows, the company also plans to switch out the USB connection from the tracking system for wireless accessibility and offer C-Scan as a homecare solution. Patients could swallow the capsule, download the information into a cellphone or other device, send it to their doctor and get the results without ever leaving the comfort of their home.

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