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Defense Department funding is helping expand study of experimental drugs to prevent acute respiratory distress syndrome in COVID

Researchers who have evaluated whether Vadostat can help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients received $ 5.1 million in funding from the US Department of Defense (DOD) to expand the second phase of the clinical trial at the university from Texas Health Science Center in Houston (UTHealth).

Vadostat is a hypoxic-induced investigational prolylhydroxylase inhibitor, or HIF-PHI, designed to mimic the physiological effect of elevation on oxygen availability. At higher altitudes, the body responds to decreased oxygen availability as HIF stabilizes, which may improve oxygen delivery to tissues. HIF stabilization can help suppress alveolar inflammation, which is a major problem faced by patients with lung disease associated with COVID-19 when they develop acute respiratory distress syndrome. The drug is under investigation in the United States but has been approved for use in Japan.

“It is wonderful that we have COVID-19 vaccines available now, but they will not directly help patients who are already in hospital or who will develop the disease in the future,” said Holger Eltschig, MD, head of the department. Anesthesiology with McGovern Medical School at UTHealth. In addition to vaccination, we urgently need treatments to prevent acute respiratory distress syndrome, one of the most lethal complications of severe COVID-19. If we can stop coronavirus infection early on before lung complications that cause death emerge, the outcomes for COVID-19 will be much better. ”Eltzschig is also director of UTHealth Center for Perioperative Medicine and distinguished president of John P. and Kathrine G. McGern University.

The award is awarded by the Department of Defense’s Peer-reviewed Medical Research Program as the COVID Clinical Experimental Award. Only 4.2% of all applications submitted were awarded funding.

“This study could prove critical for people on active duty with the armed forces as well as veterans,” Eltzschig said. COVID-19 has had a particular impact on the Navy, with individuals on board ships like aircraft carriers in close environments and unable to social distancing. If innovative oral investigative treatment could prevent ARDS, that would be great. Also, our country’s veterans tend to be older, have comorbidities, and particularly suffer from the dire consequences of COVID-19, so it would be great if you were able to help them as well. “

Vadadustat, developed by Akebia Therapeutics, Inc. , Recently completed the development of a phase III global clinical trial for treating anemia due to chronic kidney disease in patients undergoing dialysis rather than dialysis, and Akebia expects to submit a new drug application (NDA) from Vadostat to the Food and Drug Administration for these indications as soon as possible in 2021.

Previously published preclinical studies led by Eltzschig showed that HIF fixation can protect the lungs of mice with acute respiratory distress syndrome. His core science and translation team in anesthesiology is collaborating with the medical team of Ben Bobrow, MD, chief of the department of emergency medicine at McGovern Medical School, to take the idea from seat to bed to see if it can help COVID-19 patients.

“Dr. Bobro and his clinical team of nurses and researchers helped us build the experience quickly. I’ve never seen a clinical trial go from just an idea in March to enrolling patients in four months. It’s really cool and we couldn’t do without Akebia, UTHealth’s Center for Clinical and Transgender Sciences.” , And Bobrow’s clinical group collaboration with my localized group, “Eltzschig said.

“Lots of people and departments at UTHealth, Memorial Hermann, and Harris Health have come together to bring this cutting-edge experience together faster than ever to try to help people with acute lung injuries of COVID-19.” Said Bobbro, President of John P. and Katherine G. McGovern in Emergency Medicine: “Dr. Eltzschig and I were inspired by the potential for this new trial to have a major impact on COVID-19 patients.” Bobru and Eltschig attend doctors at Memorial Hermann-Texas Medical Center.

A randomized trial began enrolling patients at Memorial Hermann Texas Medical Center in July. Defense Department funding helped expand the trial to include Memorial Hermann Southwest Hospital, Memorial Hermann Greater Heights Hospital, Memorial Hermann Memorial City Medical Center, as well as Harris Health’s Lyndon Johnson Hospital. Currently, 75 patients have been registered.

“It’s unclear how long COVID-19 will remain prevalent, so it is imperative to expand the single-center experience to other locations,” said Eltzschig.

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The trial was initially funded by Akebia Therapeutics, Inc. And a donor grant to the UTHealth Center for Clinical and Translational Sciences.

Other faculty at McGovern School of Medicine involved in the study included Elizabeth Jones, MD; Samuel Luber, MD; George Williams, MD; Polina Sergut, MD; David Robinson, MD; Marie Françoise Dorsot, PhD; Misha Granado, MPH, MS; Misty Ottmann, RN; Yanyue Wang, PhD; Xiaoyi Yuan, PhD; Tingting Mills, PhD; Boyun Kim, PhD; Christian Noval, RN; James Wang, BS; Marca Lyons, MA; Robert Swachting, PhD; Charles Green, PhD; Victor Garrigua, BS; Cynthia Horton, MS; Seungwon Choi, MD; Nebras Abdul Rahman, MS.

The opinions expressed in this article are those of the author and may not reflect the official policy or position of the Department of the Army, the Department of Defense, or the US government.

Media inquiries: 713-500-3030

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