Puretech Ownership
Product Candidate
Initial Indication(s)
Stage of Development
78.6% Equity
ALV-306
Pouchitis
Preclinical
ALV-304
Inflammatory bowel disease
Preclinical
ALV-107
Interstitial cystitis/Bladder pain syndrome
Preclinical
Locally-acting therapeutic for devastating GI disease

Founded by PureTech, Alivio is pioneering targeted disease immunomodulation as a novel strategy to treat a range of chronic and acute inflammatory disorders. Targeted disease immunomodulation involves selectively restoring immune homeostasis at inflamed sites in the body, while having minimal impact on the rest of the body’s immune system.

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 engineered to respond dynamically to inflammation, releasing the enclosed therapeutics based on the degree of inflammation present. This may enable currently approved drugs to be used in existing as well as new indications with a better safety profile and improved efficacy and has the potential to allow drugs with challenging pharmacokinetics or safety profiles to come to market when they would not otherwise have done so. Alivio’s pipeline includes candidates for interstitial cystitis/bladder pain syndrome (IC/BPS), inflammatory pouchitis and inflammatory bowel disease (IBD).

The Alivio technology has been published in multiple peer-reviewed journals, including Science Translational Medicine and Nature Communications, and has demonstrated reproducible targeting of immunomodulatory compounds to inflamed tissue in preclinical models, having been validated in multiple labs using a range of animal models and indications. 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.

  • Program Discovery Process by the PureTech team
    • A key challenge in new drug development for autoimmune and inflammatory disease is that attractive drug targets are frequently expressed in both diseased and normal tissue. Consequently, PureTech was interested in identifying ways to address autoimmune disease in a targeted manner. PureTech was inspired by a key observation, which is that pathologic inflammation frequently manifests at specific sites in tissues and organs and is driven by dysfunctional immune signaling. However, traditional approaches act to broadly suppress the immune system throughout the body. This mismatch substantially limits the potential targets that can be pursued and frequently results in narrow therapeutic windows. PureTech worked with leading immunology experts and identified and in-licensed a technology created by Alivio’s co-founder Jeffrey Karp, PhD, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital, and Robert Langer, ScD, David H Koch Institute Professor at MIT, that was centered around this unique inflammation-targeting and inflammation-responsive platform in May 2016. In addition to repeating key academic work and developing product candidates, Alivio continues to move those product candidates into the clinic while PureTech oversees business development.
  • Patient Need & Market Potential
    • Results in preclinical models suggest the Alivio technology could be applied to diseases, such as inflammatory bowel disease (IBD), pouchitis, inflammatory arthritis, organ transplantation and interstitial cystitis or bladder pain syndrome (IC/BPS). These diseases collectively impact tens of millions of patients in the United States alone and have limited treatment options.
    • IC/BPS is a chronic bladder condition that consists of discomfort or pain in the bladder or surrounding pelvic region and is often associated with frequent urination. It is estimated to affect four million to 12 million people in the United States. Current treatments fail to control pain in many patients.
    • Pouchitis is estimated to affect between 70,000 and 135,000 people in the United States.
    • IBD is estimated to affect approximately three million people in the United States.
  • Innovative Approach to Solving the Problem
    • Alivio's approach to targeted disease immunomodulation is a long sought-after approach that has the potential to broadly enable new medicines to treat a range of chronic and acute inflammatory disorders, including enabling the use of drugs which were previously limited by issues of systemic toxicity or pharmacokinetics (PK).
    • To achieve the vision of selective immunomodulation, Alivio is developing a proprietary platform centered on a class of self-assembling hydrogels that selectively bind to inflamed tissue. Alivio’s platform has been validated in multiple labs using a range of animal models and indications. The platform is able to entrap a wide array of active pharmaceutical ingredients (APIs), including small molecules, biologics and nucleic acids. By selectively targeting API pharmacology to inflamed tissue, Alivio is developing product candidates that are designed to selectively treat autoimmune disease without having related systemic toxicities. Alivio’s pipeline includes candidates for inflammatory pouchitis, IBD and IC/BPS.
  • Milestones Achieved
    • In January 2019, Alivio entered into a research collaboration, option and license agreement with Imbrium Therapeutics L.P. to advance Alivio’s product candidate, ALV-107, through clinical development. Under the terms of the agreement, Alivio is eligible to receive up to $14.8 million in upfront and near-term license option exercise payments and is eligible to receive royalties on product sales and over $260.0 million in research and development milestones. Alivio retains the rights of its inflammation targeting platform for a broad range of internal and partnering applications.
  • Expected Milestones
    • Alivio expects to file an IND for ALV-306, its lead product candidate, in pouchitis and initiate a clinical trial in 2021.
    • Alivio also plans to file an IND for ALV-107 for IC/BPS in 2021 and an IND for ALV-304 in IBD in 2022.

The Alivio technology has been published in multiple peer-reviewed journals, including Science Translational Medicine and Nature Communications, and has demonstrated reproducible targeting of immunomodulatory compounds to inflamed tissue in preclinical models, having been validated in multiple labs using a range of animal models and indications. 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.


Alivio is pioneering targeted disease immunomodulation

Inflammation-targeted

 

Active at the site of disease with limited systemic exposure



Engage targets in immune and/or nervous system

Can engage target using whatever molecule(s) is optimal




Bone fide pipeline potential

 

Built using unique and proprietary platform