Puretech Ownership1
Therapeutic Candidate2
Initial Indication(s)
Stage of Development
78.0% Equity
ALV-107
Interstitial cystitis/Bladder pain syndrome
Preclinical
ALV-304
Inflammatory bowel disease
Preclinical
ALV-306
Chronic pouchitis
Preclinical

1 As of December 31, 2020, PureTech’s percentage ownership of Alivio was approximately 78.0 percent on a diluted basis. This calculation includes outstanding shares, options, and warrants, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans.
2 Therapeutic candidates are investigational and have not been cleared by the FDA for use in the United States.

Pioneering inflammation targeted disease immunomodulation

Alivio is pioneering inflammation-targeted disease immunomodulation, which involves selectively restoring immune homeostasis at inflamed sites in the body, while having minimal impact on the rest of the body’s immune system, as a novel strategy to treat a range of chronic and acute inflammatory disorders. This long sought-after approach 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 advancing a proprietary platform centered on a class of self-assembling therapies that selectively bind to inflamed tissue. Alivio’s platform has been validated in multiple labs using a range of animal models and indications and the work has been published in six journal articles in peer-reviewed journals. The platform is able to entrap a wide array of application programming interfaces (APIs) including small molecules, biologics and nucleic acids. By selectively targeting API pharmacology to inflamed tissue, Alivio is developing therapeutic candidates that are designed to selectively treat autoimmune disease without having related systemic toxicities. Alivio’s pipeline includes candidates for inflammatory bowel disease (IBD), chronic pouchitis and interstitial cystitis or bladder pain syndrome (IC/BPS).

 

 

  • 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, we were interested in identifying ways to address autoimmune disease in a targeted manner. We were 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. We worked with leading immunology experts and identified and in-licensed a technology created by Alivio’s Co-Founder 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, that was centered around this unique inflammation-targeting and inflammation-responsive platform in May 2016. In addition to repeating key academic work and developing therapeutic candidates, Alivio continues to move those therapeutic candidates into the clinic while we oversee business development.
  • Patient Need & Market Potential
    • Results in preclinical models suggest the Alivio technology could be applied to diseases such as IBD, chronic pouchitis, inflammatory arthritis, organ transplantation and 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. Chronic pouchitis is estimated to affect between 20,000 and 44,000 people in the United States. IBD is estimated to affect approximately three million people in the United States.
  • Milestones Achieved & Development Status
    • In December 2018, Alivio entered into a research collaboration, option and license agreement with Imbrium Therapeutics L.P., an entity affiliated with Purdue Pharma LP (Purdue) to advance Alivio’s therapeutic candidate, ALV-107, designed to be a potential non-opioid for IC/BPS through clinical development and commercialization. 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 low single digit to low teens royalties in tiers on product sales and over $260.0 million in research and development milestones. Imbrium does not currently have any ownership interest in ALV-107, but does have an option to exercise for rights to develop ALV-107 under the agreement. Imbrium also has an option to collaborate on a limited number of additional compounds utilizing Alivio’s inflammation-targeting technology, as well as an option to invest in Alivio’s next equity financing. We are continuing to monitor the impact, if any, of the announced Chapter 11 bankruptcy by Purdue on this collaboration agreement.
  • Expected Milestones
    • Alivio expects an IND filing for ALV-107 for IC/BPS in 2021 and an IND for ALV-304 for IBD in 2023.
    • Alivio is also evaluating the potential application of its proprietary platform to enable the oral administration of biologics in additional indications. Alivio also has ongoing discovery efforts to expand its pipeline.

A majority of the board of directors of Alivio are PureTech employees. These PureTech employees actively manage the day-to-day business activities of Alivio and together with Alivio’s Chief Executive Officer and the board of directors of Alivio, which is controlled by PureTech, direct the strategy and decision making in connection with the clinical and regulatory development of Alivio’s therapeutic candidates. As a result, we exert substantial control over the clinical and regulatory development of Alivio’s therapeutic candidates. Additionally, Alivio’s lab and office space is shared with our lab and office space. Alivio is well-protected with a robust intellectual property portfolio. Alivio was incorporated in December 2015.

The Alivio technology has been published in six journal articles in peer-reviewed journals, including Science Translational Medicine and Nature Communications, and has been validated in multiple labs using a range of animal models and indications.