Award will support advancement of ALV-304 into the clinic for the potential treatment of inflammatory bowel disease
Alivio Therapeutics, a biotechnology company developing an inflammation-targeting disease immunomodulation platform for the potential treatment of chronic and acute inflammatory disorders, today announced a $3.3 million U.S. Department of Defense (DoD) Technology/Therapeutic Development Award to advance its product candidate, ALV-304, for the treatment of inflammatory bowel disease (IBD). The funds will support Alivio’s preclinical research and development activities to potentially enable the filing of an investigational new drug (IND) application for 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. "ALV-304 could potentially offer a novel therapeutic option to improve the health of patients living with moderate to severe forms of IBD. We are excited by this potential and the DoD award that will support our efforts to advance ALV-304 into the clinic."
IBD is estimated to affect approximately three million people in the United States, and other autoimmune diseases affect over 20 million people in the United States. Many of the existing interventions are limited by toxicities and systemic immune suppression.
"Although patients with mild forms of inflammatory bowel disease can be effectively managed, there is a large unmet need for patients with moderate to severe forms of the disease that are refractory to current therapies," said Athos Bousvaros, M.D., MPH, professor and associate chief, Division of Gastroenterology, Hepatology and Nutrition; associate director, Inflammatory Bowel Disease program at Harvard Medical School. "I am excited by the potential of ALV-304 to treat these patients and I am hopeful that this award will accelerate development of this potentially new therapy for IBD."
Alivio is developing product candidates that are designed to selectively treat autoimmune disease without having related systemic toxicities. Alivio’s pipeline includes candidates for IBD, pouchitis, and interstitial cystitis or bladder pain syndrome (IC/BPS).
About the U.S. Department of Defense Award
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense through the Peer Reviewed Medical Research Program under Award No. W81XWH-18-1-0566. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
About Alivio Therapeutics
Alivio Therapeutics, Inc. is a biotechnology company pioneering inflammation-targeting disease immunomodulation as a novel strategy to treat a range of chronic and acute inflammatory disorders. 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 which were previously limited by issues of systemic toxicity or pharmacokinetics.
Alivio is developing a proprietary platform centered on a class of self-assembling therapies that selectively bind to inflamed tissue. 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. The platform can enable a wide array of active pharmaceutical ingredients (APIs), including small molecules, biologics and nucleic acids. Alivio’s pipeline includes candidates for IBD, pouchitis, and interstitial cystitis or bladder pain syndrome, or IC/BPS.
Alivio was founded by PureTech (LSE: PRTC) and leading immunology experts Jeffrey Karp, Ph.D., Professor of Medicine at Brigham and Women’s Hospital and Robert Langer, Sc.D., David H. Koch Institute Professor at MIT.
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