LYT-500

Our programs 1
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-500
Oral IL-22 +
Immunosuppressant
IBD

Preclinical

Inflammatory bowel disease

~3.9M U.S.

Therapeutic candidate being advanced for the potential treatment of inflammatory bowel disease (IBD) that is designed with a dual mechanism of action to provide both mucosal repair and targeted resolution of tissue inflammation.
Phase completedPhase in progress

1 The FDA and corresponding regulatory authorities will ultimately review our clinical results and determine whether our wholly-owned therapeutic candidates are safe and effective. No regulatory agency has made any such determination that LYT-500 is safe or effective for use by the general public for any indication.

Oral biologic combination therapy for the potential treatment of inflammatory bowel disease

LYT-500 is an oral combination therapy in development for inflammatory bowel disease (IBD). Using our Alivio™ technology platform (see here), we have combined two active agents into a single therapeutic candidate designed to enhance the local treatment and healing of inflamed tissues, while minimizing systemic exposure of these agents.

  • Key Points of Innovation & Differentiation
    • Using our Alivio technology platform, a biologic agent and/or small molecule drug can be administered in an oral dosage form that offers the potential to selectively act at the inflamed tissues locally to maximize efficacy, while minimizing toxicity by reducing systemic exposure of the drugs.
    • LYT-500 is an oral therapeutic candidate in development for the potential treatment of mucosal barrier damage in people with IBD. It contains a unique combination of IL-22 and an immunosuppressant drug, which is designed to address the two key underlying causes of IBD pathogenesis and progression, namely mucosal barrier disruption and inflammation. Unlike many therapies in development for IBD, LYT-500 is designed with a dual mechanism of action to provide both mucosal repair and targeted resolution of tissue inflammation, which are critical for optimal disease management.
  • Program Discovery Process by the PureTech Team
    • A key challenge faced in developing new drugs for the treatment of autoimmune and inflammatory disease is that attractive drug targets are frequently expressed in both diseased and normal tissue. Consequently, we are interested in identifying ways to address autoimmune disease in a more targeted manner. We have been inspired by the key observation that pathologic inflammation driven by dysfunctional immune signaling frequently manifests at specific sites in tissues and organs. However, the current treatments and therapeutic approaches act broadly to suppress the immune system throughout the body. This mismatch substantially limits the potential targets that can be pursued due to narrow therapeutic windows. Moreover, combining therapies to address multiple aspects of the autoimmune diseases is quite challenging due to both distinct and overlapping drug toxicity profiles. Working with leading scientists, we identified and in-licensed a technology platform in May 2016 that was created by Jeffrey Karp, Ph.D., Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and Robert Langer, Sc.D., David H Koch Institute Professor at MIT. As demonstrated in multiple publications, our Alivio technology platform can be used to develop therapeutic candidates that selectively target inflamed tissues and release drugs in proportion to the severity of inflammation.
  • Patient Need & Market Potential
    • IBD is estimated to affect approximately 3.9 million people in the U.S.2, with monoclonal antibody therapies being the preferred treatment option for patients with moderate-to-severe disease. However, these therapies must be provided through multiple injections over time and are associated with several limitations including a lack of efficacy for some patients, dose-limiting adverse events (AEs), loss of efficacy over time via anti-drug antibody development and the potential for opportunistic infections or malignancies.
    • We believe that oral administration of therapeutic candidates generated from our Alivio technology platform can potentially overcome these challenges by targeting multiple mechanisms of disease pathogenesis and minimizing the potential for systemic side effects.
  • Milestones Achieved & Development Status
    • We have developed an inflammation-targeting IL-22 composition with analytical data to support high IL-22 loading, high encapsulation efficiency, preservation of biologic activity, enzyme-mediated drug release and stability in simulated intestinal fluids. In addition, we have a comparable data set for an inflammation-targeting composition that combines IL-22 with an immunosuppressant drug.
    • We have completed initial preclinical evaluation of an inflammation-targeting IL-22 composition in a preclinical IBD model, where we demonstrated improvement in multiple endpoints related to mucosal healing.
    • We have demonstrated efficacy of the inflammation-targeting drug combination in a rodent IBD model, with improvements observed across several endpoints related to mucosal healing and inflammation.
    • We have developed oral dosage forms to enable preclinical testing of the inflammation-targeting IL-22 alone and in combination with an immunosuppressant drug and have initiated animal studies to evaluate their efficacy.
  • Intellectual Property
    • The intellectual property portfolio supporting LYT-500 consists of coverage around both the broader inflammation-targeting platform and the specific drug combination candidate. Platform intellectual property is supported by one patent family that has been exclusively licensed from the Brigham and Women’s Hospital, which includes seven issued patents to date and five pending applications within and outside the U.S. In addition, intellectual property specific to LYT-500 includes two patent families which are owned by Alivio that consist of 13 patent applications within and outside the U.S.

2 Inflammatory Bowel Disease (IBD) in the United States. (2021, November 09). https://www.cdc.gov/ibd/data-statistics.htm

Our Alivio technology platform underlying LYT-500 is designed to target biologics and other drugs to sites of inflammation in a localized manner while limiting their systemic exposure, which offers the potential to significantly improve both the safety and efficacy profile of the therapy. LYT-500 is an oral therapeutic candidate that we are developing for the potential treatment of mucosal barrier damage in people with IBD. We believe the targeted activation and oral formulation offered by Alivio offers a path to unlocking the full therapeutic potential of anti-inflammatory drugs in a way that matches the chronic, variable expression of autoimmune diseases.