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Thanks to a new approach to the treatment of Alzheimer’s disease, the Harrison College of Pharmacy Raj Amin is partnering with biopharmaceutical company Oleolive to advance the drug candidate into phase 2 studies.
The study will be supported by a $2.58 million grant through the National Institutes of Health, or NIH, Small Business Technology Transfer Program. The compound was designed and developed by Amin, an associate professor at Department of Drug Discovery and Development, and collaborators including Tracey Ward, professor of medicinal chemistry and medicinal biochemistry at Ferris State University, and Orlando Acevedo, professor of chemistry at the University of Miami. To help commercialize the compound, Auburn’s technology transfer office, known as The IP Exchange, applied for and was granted a US patent.
The compound, called AU9, is an intellectual property manufactured and designed at Auburn and Harrison College of Pharmacy.
“I am very excited about the capabilities the NIH is giving us to advance our studies and enable us to proceed with a potential Investigational New Drug Application with the Food and Drug Administration,” Amin said. “Our capabilities to design and develop novel therapies at Auburn in the Drug Discovery and Development department will allow us to advance the field of drug discovery related to Alzheimer’s disease.”
AU9 is a new drug that activates the peroxisomal proliferating nuclear receptor, activating the delta and partially gamma receptor, also known as PPAR delta and gamma.
The in silico design and development of AU9, i.e. it was designed and developed by computer simulation, induces the expression of neurotrophins that act to enhance synaptic plasticity and memory while separately reducing inflammation associated with disease progression.
“Our drug candidate is unique because it was engineered in silico to activate the PPAR nuclear receptor,” Amin said. “This is a very exciting and promising area with many challenges and opportunities to explore, including extensive testing needed to assess the safety, efficacy and bioavailability of this substance.”
Early research was supported by an NIH R15 grant awarded to Amin and Vishnu Suppiramaniam, Gilliland Professor at Harrison College of Pharmacy, focused on understanding how AU9 ameliorates behavioral deficits and neuronal function in animal models of the disease. of Alzheimer’s.
After the success of this study, Amin partnered with Oleolive to continue work on the drug. To enable AU9’s commercial development and strengthen continued small business financing, The IP Exchange licensed Auburn’s commercial rights to Oleolive. Together, Amin and Oleolive received an NIH Small Business Innovation Fellowship for Phase 1 work where they learned more about the drug’s bioavailability in the brain, as well as the impact on pathologies. , especially beta-amyloid.
The Small Business Technology Transfer Program, also known as STTR, is an NIH program that supports translational research between small businesses and nonprofit research institutions. Rusty Arnold, a professor at Harrison College of Pharmacy, is a co-principal investigator on the Phase 2 grant.
“The Phase 2 project is considerably more financially intensive and studies in different animal models the biosafety for liver and heart after prolonged treatment periods,” Amin said. “These studies focus on Good Manufacturing Practice facilities. Additionally, Phase 2 grants have a significant commercial component that focuses on evaluating large industrial-type biopharmaceutical companies with scientists in the field of neuroscience drug discovery.
The study’s small business partner, Oleolive, is a biopharmaceutical company based in Shreveport, Louisiana. Oleolive has experience in developing and commercializing potential therapies for various diseases.
“Oleolive is focused on building the business component of the app,” Amin said. “It helps to understand the value of the drug candidate as it progresses towards an investigational new drug application with the FDA. In addition, they also collect all the information necessary for application requirements, including safety and bioavailability.
With all the work required to bring AU9 to this point in the process, Amin is grateful for the support and opportunities from Auburn and Harrison College of Pharmacy to design and develop such a novel drug.
“We are fortunate in the Department of Drug Discovery and Development to have personnel and equipment available for the discovery, design and development of new drugs for various diseases,” Amin said. “I sincerely appreciate the tremendous support from the department, college, dean’s office, and Auburn University that allows us to be competitive at the highest level in the field of drug discovery.”