Multiple Sclerosis Trial for Lisinopril Granted $1.4 Million in New Funding From NCATS

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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Lisinopril
LisinoprilTransparency Life Sciences, LLCĀ (TLS), the first clinical-stage drugĀ development company based on open innovation in the world, recentlyĀ receivedĀ a $1.4 millionĀ Small Business Innovation Research (SBIR) grant intended for its phase IIa proof-of-concept study, which is assessing the utility of the ACE inhibitor lisinopril as an adjunctive treatment for patients with multiple sclerosis. The Repurposing a Generic ACE Inhibitor to treat Multiple Sclerosis fundingĀ was granted by theĀ National Center for Advancing Translational Sciences (NCATS) of theĀ U.S. National Institutes of Health (NIH).
“This project advances NCATS’ mission to innovate inĀ both the scientific and operational aspects ofĀ translation,” said NCATS DirectorĀ Christopher P. Austin, MD. “ItĀ aims to make drugĀ repurposing more efficient and better measure patient-relevant clinical trial outcomes, all in theĀ context of aĀ company that operates in theĀ new arena of openĀ innovation drug development.”
TSL is developing lisinopril, which is a widely used generic antihypertensive, and has licensed its intellectual property with exclusivity from Stanford University, regardingĀ the use of lisinopril as a treatment for multiple sclerosis. The George A. Zimmermann Professor of Neurology and Neurological Sciences & Pediatrics atĀ the Stanford School ofĀ Medicine, Dr. Lawrence Steinman, who is also aĀ co-founder of Transparency and Chair of TLS’s Scientific Advisory Board, has been leading the research.
The clinical trial is being conducted at the Icahn School of Medicine at Mount Sinai,Ā with Fred D.Ā Lublin, MD, the Saunders Family Professor ofĀ Neurology and the Director ofĀ the Corinne Goldsmith Dickinson Center for Multiple Sclerosis, as principal investigator.Ā “Preclinical data suggest that lisinopril used as an adjunctive therapy may have the potential to improve the efficacy of current MSĀ treatments while reducing costs. I welcome theĀ opportunity to test this hypothesis, along withĀ Transparency’s innovative approach to conducting clinical trials,” the researcher said. In addition, the treatment has been cleared by theĀ U.S. Food and Drug Administration (FDA) with an Investigational New Drug (IND) application.
“We are thrilled that NCATS is supporting this pioneering study designed to harness the wisdom of the crowd andĀ the promise ofĀ telemonitoring technologies, with aĀ goal of making clinical trials more patient-centric, more transparent andĀ dramatically lessĀ costly,” said theĀ CEO of Transparency Life Sciences,Ā Tomasz Sablinski, MD, PhD.Ā “Our model is applicable to new chemical entities, as well as to repurposed drugs such as lisinopril, where safety isĀ well documented, but low perceived return onĀ investment has discouraged furtherĀ clinical development. Using the cost-effective TLS approach to establish clinical proof-of-concept could make it possible toĀ test many more repurposing candidates in the future.”
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TLS has also established a partnership with theĀ comprehensive provider of telemedicine services, AMC Health, for the study, which may have assisted in securing NIH funding for the lisinopril project. AMC Health willĀ deploy its mobileĀ technology to enable video study visits at the patients’ homes, collect biometric data, as well as the remote assessment of a primary MS endpoint.
TheĀ clinical-stage drugĀ developer has been engaged not only in telemonitoring, but also in crowdsourcing, which was crucial for the lisinopril study.Ā TLS developed the clinical protocol for the lisinopril study with crowdsourced input from MS researchers, physicians and patients, and it was designed in order toĀ minimize the need forĀ patient site visits, byĀ relying primarily on telemonitoring and video interactions with subjects.