V565 Expected to Be The First Oral Biologic Treatment for IBD

From the clinical stage company VHsquared, V565 is moving along the development pipeline towards a status as the first oral biologic registered for IBD.

What is V565?

Calling itself “The Oral Domain Antibody Company”, biotechnology company VHsquared is currently developing seven products for treating IBD. Among these, the most advanced is V565, a new IBD treatment that aims to produce the dramatic results associated with biologic therapies, combined with the benefits of an orally administered drug.

As an anti-TNFα domain antibody, V565 is a biologic therapy (other IBD biologics include familiar names such as Remicade, Humira, and Cimzia). However, instead of requiring an injection or infusion, this new IBD medication comes in the form of small, swallowable tablets that dissolve in the small intestine.

The developers of V565 point to potential advantages of this new oral IBD therapy option, including more targeted activity, reduced immunogenicity (this occurs when a drug provokes an undesired response from the body’s immune system), and reduced risk of immunosuppression and infection. VHsquared explains that the oral form of their new biologic treatment means that the medication is delivered directly to the site of action—the small and large intestine—and in optimal concentrations.

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In a 2017 press release announcing the launch of the first Phase 2 trial with human patients, Rod Richards, CEO of VHsquared spoke about the outlook for V565:

“[...] We are pleased to have progressed rapidly to Phase II trial enrolment. We believe that V565 offers a transformational approach to the treatment of IBD, with oral delivery of the Vorabody achieving a highly desirable clinical impact.”

What does V565 do?

Like other anti-TNFα therapies, V565 is designed to target and inhibit a specific cytokine (tumor necrosis factor) involved in the pathology of inflammatory diseases.

Patients take V565 as mini capsules which are released in the stomach and dissolved in the small intestine, concentrating in the ileum and colon. Researchers are still examining how the drug concentrates within the inflamed gut mucosa, but it is expected that the drug will work by reducing inflammation and help return the intestinal lining to a healthy state.

Studies on V565

Previous studies on V565 have shown this upcoming IBD treatment option to be safe and well tolerated in both healthy volunteers and patients with IBD. In a Phase 1 study, patients taking V565 showed minimal signs of systemic exposure, with no drug-induced antibodies. This is promising news, as a large number of IBD patients on biologic therapies develop anti-drug antibodies—even though this is a natural process in which the body tries to protect itself, anti-drug antibodies work against the drug, rendering the treatment less effective.

What is V565’s Current Status?

V565 is currently in Phase 2 clinical development for Crohn’s disease and is recruiting for participants for a 6-week study of V565’s efficacy, safety and tolerability. As part of the ongoing Phase 2 study, HARBOR, researchers are investigating the efficacy of the Crohn’s treatment in patients with moderately to severely active Crohn’s disease, measuring their changes in symptoms, inflammation biomarkers, and appearance of the intestinal lining. VHsquared is also examining the V565 for ulcerative colitis.

How Can I Learn More About V565?

Learn more about new oral IBD treatment options and determine whether you can participate in a clinical trial near you by answering a few questions at Discover Therapies.


Pache, I; Rogler, G; Felley, C (2009). TNF-alpha blockers in inflammatory bowel diseases: practical consensus recommendations and a user's guide. Swiss Medical Weekly, 139(19-20):278-287.
T. Carlton, K. Roberts, A. Vossenkämper, M. West, L. Maggiore, M. Cubitt, K. Ray, J. Reckless, H. Mohammed, G. Parkes, P. Irving, G. Whale, J. Robinson, T. MacDonald, S. Nurbhai and S. Crowe. V565, an intestinal protease-stablised oral anti-TNFα Vorabody inhibits inflammation in ulcerative colitis patients. Powerpoint Presentation. 11th Annual Proteins and Antibodies Congress, April 16-17 2018, London UK & 17th Annual Pep Talk, January 8-12 2018, San Diego, USA. Retrieved from http://www.vhsquared.com/wp-content/uploads/2018/04/VHsquared-Pep-Talk-18-OG-18-V56503-inflammation-inhibition.pdf
VHsquared Ltd. Transforming the treatment of inflammatory bowel disease. Retrieved from http://www.vhsquared.com/about/
2017 February 20. First patients entered into Phase II trial of VHsquared's lead Vorabody product V565. VHsqured. Press Release. Retrieved from http://www.vhsquared.com/wp-content/uploads/2015/09/VH2-1st-patient-press-release-17-02-17-FINAL-DATED.pdf

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