ALIVIO (Inflammation-Targeting Technology)

(ALV-107)

Immune System

TRIAL PHASE
AFFILIATEFOCUSPRTC
OWNERSHIP
PRECLINICALPHASE 1PHASE 2PHASE 3/
PIVOTAL
FILINGFDA CLEARED
Alivio
Targeted Disease Immunomodulation for Acute and Chronic Inflammatory Disorders
82.7%

Immune System

Alivio
Targeted Disease Immunomodulation for Acute and Chronic Inflammatory Disorders
82.7%
Preclinical
Site specific inflammation targeting that spares non-inflamed tissue in GI and other systems

Founded by PureTech Health, Alivio Therapeutics is pioneering targeted disease immunomodulation as a novel strategy to treat a range of chronic and acute inflammatory disorders. Targeted disease immunomodulation involves tuning the immune system exclusively at the site of disease in the body, with minimal impact on the rest of the immune system. This long sought-after approach has the potential to treat a range of chronic and acute inflammatory disorders, including ones that would otherwise be difficult to treat.

Based on the research of Dr. Jeffrey Karp, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital, and Dr. Robert Langer, David H Koch Institute Professor at MIT, Alivio’s proprietary inflammation-targeting platform is designed to administer therapeutics to the sites of inflammation, while sparing normal tissues from unnecessary drug exposure. The technology is also engineered to respond dynamically to inflammation, releasing the enclosed therapeutics based on the degree of inflammation present. Alivio’s pipeline includes candidates for interstitial cystitis/bladder pain syndrome (IC/BPS), inflammatory pouchitis, and inflammatory bowel disease (IBD).

There are numerous health conditions caused by chronic and acute inflammation. Despite the magnitude of the unmet need and the substantial progress in basic research, few truly novel drugs have come to market in the last decade. A major complicating factor has been that the pathways that modulate inflammation act broadly, so agents that seek to dampen inflammation locally can have substantial side effects and toxicity. Targeted disease immunomodulation using our inflammation-targeting technology is a new approach to address this challenge in inflammatory disorders.

  • Patient Need & Market Potential
    • There is a substantial opportunity for targeted therapies that selectively reduce disease associated inflammation without leading to broad immunosuppression or other systemic effects.
    • Results in preclinical models suggest the Alivio technology could be applied to diseases such as IBD, inflammatory arthritis, organ transplantation, and interstitial cystitis. These diseases collectively impact tens of millions of patients in the U.S. alone and have limited treatment options.
  • Our Approach to Solving the Problem
    • Alivio’s inflammation-targeted technology platform is designed to help immunomodulatory compounds specifically target inflamed tissue and become bioavailable based on signals from the diseased tissue on the severity of the local inflammation.
    • The innovative properties of Alivio’s technology may enable currently approved drugs to be used in existing as well as new indications with a better safety profile and improved efficacy. The technology also has the potential to allow drugs with challenging pharmacokinetics or safety profiles to come to market when they would not otherwise have done so.
  • Intellectual Property
    • Alivio has broad intellectual property coverage worldwide, currently owning or having exclusive rights to twenty-seven (27) patent applications in eight (8) families of patent filings, two of which patent applications were allowed in the U.S. in 2018.
    • Alivio’s IP estate covers composition of matter, novel formulations, and methods of using nanostructured gels for the delivery of therapeutic agents.
  • Team
    • The Alivio team has strong backgrounds in biomaterials, preclinical model development, and analytical chemistry.
    • Scientific co-founders include Dr. Robert Langer (PureTech Health and MIT) and Dr. Jeffrey Karp (BWH and Harvard Medical School).
  • Collaborations
    • In September 2018, Alivio announced a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award. The funds will support Alivio’s preclinical research and development activities for product candidate, ALV-107, for treatment of interstitial cystitis/ bladder pain syndrome (IC/BPS) with Hunner’s lesions.
    • In January 2019, Alivio entered into a partnership with Purdue Pharma LP to advance Alivio’s product candidate ALV-107, a non-opioid product candidate for IC/BPS, through clinical development with an option exercisable by Purdue to collaborate on a limited number of additional compounds utilizing Alivio’s inflammation-targeting technology. Under the terms of the agreement, Alivio will receive up to $14.75 million in upfront and near-term license exercise payments and is eligible to receive royalties on product sales and over $260 million in research and development milestones.
  • Expected Milestones
    • Alivio expects to initiate a clinical study for its lead product, ALV-306, in pouchitis in 2020.

The technology platform has been published in multiple peer-reviewed journals, including Science Translational Medicine and Nature Communications, and the technology is the first of its kind to demonstrate reproducible targeting of immunomodulatory compounds to inflamed tissue in preclinical models, having been validated in multiple labs and in ten different preclinical models of inflammation where the inflammation occurred in different parts of the body (e.g., the GI system, the bladder, joints, skin, etc.). With this platform, Alivio aims to address the dozens of conditions where inflammation is a central part of the underlying disease pathology, but where targeted and effective treatment options are lacking.


Targeting Inflammation


Validation in Multiple Disease Models