Boston Biotech, Alivio Receives Substantial Grant from U.S. DoD, a Second in Two Years

By Eduardo Longoria

Boston-based, Alivio Therapeutics, is a biotechnology company founded by PureTech (LSE: PRTC) and leading immunology experts Jeffrey Karp and Robert Langer. PureTech, a biotherapeutics company dedicated to the development of medicines for devastating diseases and has created a pipeline comprised of 24 products and product candidates, including two that have received FDA clearance and European marketing authorization.

Therapeutic Development Award

Alivio is currently developing an inflammation-targeting disease immunomodulation platform for the potential treatment of chronic and acute inflammatory disorders. On October 5th, the company announced a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award to advance its product candidate, ALV-304, which is intended for the treatment of inflammatory bowel disease (IBD). The funds will potentially enable the filing of an investigational new drug (IND) application for ALV-304 support through Alivio’s preclinical research and development. Earlier in 2018, Alivio received $3.3 million from the U.S. Department of Defense to advance ALV-107, for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) with Hunner’s lesions.

Inflammatory bowel disease

Inflammatory bowel disease (IBD) affects a wide swathe of the US population and undoubtedly poses concerns for the department of defense as regards recruiting healthy soldiers. While it is possible for IBD patients to serve in the military the maintenance of their symptoms does come at a cost and the disease can still leave soldiers unfit for duty.

IBD is estimated to affect approximately three million people in the United States alone and is one of many autoimmune diseases plaguing the public. Unfortunately, many of the existing interventions for these disorders are limited by the toxicity and systemic immune suppression that often come with the positive effects of the treatment.

ALV-304

Alivio’s inflammation-targeting disease immunomodulation approach 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 platform has demonstrated proof-of-concept in ten different preclinical models of inflammation. In multiple preclinical models for the treatment of IBD, ALV-304 showed significant improvements in several efficacy endpoints compared to untreated controls. Furthermore, the inflammation-targeting properties were shown to result in very low systemic blood levels, which has the potential to limit systemic side effects.

“Our novel platform technology has the potential to generate inflammation-targeting therapies for the treatment of many acute and chronic inflammatory diseases using biologics, small molecules, or drug combinations in an oral formulation. IBD as an indication is a great pairing of our technology and an important clinical need,” said Brian Leuthner, Chief Executive Officer at Alivio.

Welcome Addition

With the recent addition of the Chief Medical Officer of Gelesis, Dr. Harry Leider, to the board of Alivio, the company has high hopes of advancing their R&D efforts. Leider played a role in the FDA submission and clearance leading to the commercialization of Plenity®, a non-stimulant aid for weight management in adults. Alivio is developing product candidates that are designed to selectively treat autoimmune disease without having related systemic toxicities. This long sought-after approach 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 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 that were previously limited by issues of systemic toxicity or pharmacokinetics.

Alivio’s pipeline includes candidates for IBD, pouchitis, and interstitial cystitis or bladder pain syndrome (IC/BPS). The platform that Alivio is developing enables a wide array of active pharmaceutical ingredients (APIs), including small molecules, biologics, and nucleic acids. The therapy is to cause selective binding to inflamed tissues.

Alivio’s platform has been highlighted in peer-reviewed journals, including in Science Translational Medicine and Nature Communications, and has been validated in multiple labs using a range of animal models and indications. With this most recent support from the DoD Alivio’s IBS treatment can expect to do well.

Editor: Rajaneesh K. Gopinath, Ph.D.

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References

1. https://static1.squarespace.com/static/572363a78259b57662fb6d90/t/5f7b4d050e1c0162012a8e81/1601916166646/Alivio+DoD+Grant_Bwire_FINAL.pdf

Author

Eduardo Longoria