In this post, we will be sharing some exciting news about Virgo’s efforts to improve care for inflammatory bowel disease (IBD) patients. But first, it will be helpful to do a quick recap of one particular pain point in the IBD care continuum — clinical trials.
Back in mid-February, we kicked off a series of blog posts highlighting the challenges with IBD clinical trials. In this series, we touched on the painfully low trial enrollment rates — each trial site enrolls an average of just over 1 patient per year — and the difficulties of participating in an IBD trial from the patient’s perspective.
According to The Mayo Clinic, current IBD treatment options either don’t work or lose effectiveness over time for the majority of patients. By delaying new treatments from reaching the market, the challenges associated with IBD trials massively impact patient care. Trial delays also impact the economics of IBD pharmaceuticals, with one study estimating that each day an IBD drug is delayed from launch can cost the trial sponsor up to $8 million in potential revenue.
Virgo is excited to take its first major step toward reducing these challenges associated with IBD clinical trials. Today, we are announcing our first collaboration with a leading pharmaceutical company — Genentech — an independent subsidiary of Roche. While we can’t disclose many details about our collaboration, we have been greatly impressed by the forward thinking nature of the Genentech and Roche teams and their interest in utilizing digital health technology to advance IBD care.
Indeed, we believe there are numerous opportunities for pharma companies to leverage digital health beyond digital therapeutics — also known as “digiceuticals”. Virgo is actively working on the following programs to optimize the pharmaceutical space for IBD and other GI diseases:
As mentioned above, patient enrollment is a major bottleneck for IBD trials. Virgo developed a suite of tools called the Virgo Clinical Trial Enrollment Accelerator (VCTEA). VCTEA leverages Virgo’s automated endoscopy video capture and analysis capabilities to broaden the search for trial-eligible patients, efficiently screen them for inclusion, and enable easier communication. We believe this has the potential to radically transform IBD trial enrollment.
There is an emerging need for telemedicine solutions, which COVID-19 has brought to light. Clinical trials for diseases such as inflammatory bowel disease often require numerous procedural and clinical visits over the course of the study. Without virtualizing these visits, clinical trials risk substantial delays due to patient concern around in-person visits or outright cancellation of procedures. By systematically archiving procedure video, Virgo can reduce the frequency of procedure visits specifically due to repeat colonoscopy, which are more frequent than most like to admit.
All major IBD clinical trials for a new drug approval must undergo some form of central reading process, which entails an unbiased panel of experts analyzing imaging and video data from the trial. While current central reading processes are well-established, they often rely on outdated technologies including external hard drive and DVD recorders for video capture. Not only are these systems cumbersome, in many cases they are not HIPAA compliant and expose hospitals and physicians to security risks.
Virgo can work directly with contract research organizations to provide clinical trials with a modern and secure endoscopy video capture, management, and analysis platform.
Virgo's HIPAA-compliant portal
Example colonoscopy video in Virgo with Auto Highlights in yellow on the timeline
According to the Food and Drug Administration (FDA) real-world data (RWD) and real-world evidence (RWE) are increasingly being used to monitor postmarket safety and make regulatory decisions. By sampling from an increasingly large pool of data, RWD and RWE allow pharmaceutical companies to make informed, data-backed predictions about new treatment protocols, useful or harmful drug interactions, and optimal clinical trial designs.
In October 2019, Takeda — a pharmaceutical leader in the IBD space — published a retrospective real-world chart review looking at the likelihood of serious adverse events associated with patients taking either vedolizumab or an anti-tumor necrosis factor-alpha (anti-TNF⍺). Vedolizumab is the pharmaceutical name for Takeda’s blockbuster IBD drug, Entyvio, which is estimated to generate nearly $2.5 billion in annual sales.
This study found that patients taking vedolizumab had a lower incidence of serious infection relative to patients on an anti-TNF⍺. These exciting results provide useful information to help inform physician decision making. However, Takeda notes, “While retrospective chart reviews are important for advancing physician understanding of the performance of treatments in clinical practice, the records reviewed may not be complete and as such chart reviews can be more prone to bias”.
The lack of video documentation in the standard endoscopy medical record renders them glaringly incomplete. Without recordings of endoscopy videos, it is nearly impossible for a retrospective chart review to reach the level of detailed analysis present in a clinical trial done for a new drug approval.
Virgo’s automated cloud video capture and management platform can help pharmaceutical companies efficiently archive endoscopy video data that will push real-world evidence to the next level.
In 2011, Marc Andreessen — founder of Netscape and the VC firm, Andreessen Horowitz — wrote, “Software is eating the world.” This has clearly proven to be the case, though healthcare seems to just now be entering it’s golden age of software.
We at Virgo are eager to assist pharmaceutical companies in adopting this mantra. If you work at a pharmaceutical company and would like to learn more about how Virgo can help improve your clinical trial enrollment, virtualize trial visits, modernize central reading, or generate real-world evidence, please don’t hesitate to reach out!