OHSU startup receives FDA Fast Track designation for new blood clot treatment

Andras Gruber, M.D., professor of biomedical engineering, OHSU School of Medicine

Blood clots contribute to dangerous, potentially deadly conditions, including venous thromboembolism and stroke. They are also a leading cause of death and long-term disability in the U.S. and worldwide.

OHSU startup, Aronora, Inc., has received Fast Track designation from the U.S. Food and Drug Administration for a new drug candidate that reverses the formation of experimental blood clots without significant increase in bleeding. The antithrombotic and anti-inflammatory drug candidate, proCase (AB002), is an injectable recombinant enzyme, E-WE thrombin.

ProCase is the first clot-busting drug to be approved by the FDA since 1987, when it approved Genentech’s recombinant tissue-plasminogen activator enzyme (tPA). Use of tPA significantly increases the risk of bleeding, limiting its clinical utility.

Fast Track designation expedites the regulatory review of drugs to treat serious or life-threatening conditions in order to get effective new drugs to patients more quickly. For Aronora, the Fast Track process will enable them to accelerate the clinical development of proCase for patients with life-threatening blood clots, including those suffering from stroke or heart attack.

Aronora Chief Executive Officer Andras Gruber, M.D., and Chief Operating Officer Erik Tucker, Ph.D., both hold faculty positions within OHSU’s Department of Biomedical Engineering in the School of Medicine. They have been working with Technology Transfer and Business Development to protect and develop several therapeutic technologies.

TTBD helped incorporate Aronora in 2012 and exclusively licensed the proCase technology from OHSU to Aronora. OHSU investigators, including Larry Sherman, Ph.D., and Owen McCarty, Ph.D., along with Aronora senior scientist Norah Verbout, Ph.D., continue research with proCase to further evaluate its therapeutic potential.

ProCase is currently in a phase 1 clinical safety trial. Since its incorporation, Aronora has developed new therapeutic approaches to thrombosis and inflammation and partnered with Bayer AG to develop antibodies, including those invented at OHSU, for the treatment of thrombotic diseases. AB023, a recombinant contact activation inhibitor antibody, is currently entering a phase 2 clinical trial and is the first new molecular entity invented and initially developed at OHSU to reach this clinical trial stage.

According to Andrew Watson, senior director of Technology Transfer at OHSU, “TTBD and Aronora have become mutual supporters over the years, and it is gratifying to see the company make such great progress with its various therapeutic programs. It is also amazing that Aronora has done so without the need to take any private investment to this point. Aronora is truly helping to support the mission of OHSU by working with TTBD to advance research discoveries into applications in the health and commercial sectors for the benefit of society.”

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