Amin of Auburn Pharmacy Develops Alzheimer’s Drug with NIH Support – Office of Communications and Marketing | Team Cansler

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With a novel approach to treating Alzheimer’s disease, Harrison College of Pharmacy’s Raj Amin is collaborating with biopharmaceutical company Oleolive to further advance the drug candidate into Phase 2 trials.

The study is supported by a $2.58 million grant from the Small Business Technology Transfer Program of the National Institutes of Health, or NIH. The compound was designed and developed by Amin, an associate professor in the 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 from 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 referred to as AU9 is an intellectual property manufactured and developed in Auburn and Harrison College of Pharmacy.

“I am very excited about the capabilities that the NIH is giving us to advance our studies and allow us to proceed with a potential review application for a new drug with the Food and Drug Administration,” said Amin. “Our capabilities to design and develop novel therapeutics in Auburn’s Drug Research and Development department will allow us to advance the field of drug discovery related to the fight against Alzheimer’s disease.”

AU9 is a novel drug that activates the peroxisomal nuclear receptor proliferator that activates receptor delta and partial gamma, also known as PPAR delta and gamma.

The in silico design and development of AU9, meaning it was designed and developed through computer simulation, induces the expression of neurotrophins that enhance synaptic plasticity and memory while reducing inflammation associated with disease progression.

“Our drug candidate is unique because it was designed in silico to activate the nuclear receptor PPAR,” said Amin. “This is a very exciting and promising area with many challenges and opportunities to be explored, including extensive testing needed to evaluate 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, which focused on understanding how AU9 improves behavioral deficits and neuronal function in animal models of Alzheimer’s disease .

After successfully completing this study, Amin partnered with Oleolive to continue work on the drug. To enable commercial development of AU9 and strengthen the drive for small business financing, The IP Exchange licensed Auburn’s commercial rights to Oleolive. Together, Amin and Oleolive received a Small Business Innovation Research Grant from the NIH for Phase 1 work to learn more about the drug’s bioavailability in the brain and its impact on pathologies including amyloid beta.

The Small Business Technology Transfer Program, also known as STTR, is a program within the NIH that supports translational research between small businesses and nonprofit research organizations. Rusty Arnold, a professor at Harrison College of Pharmacy, is the co-principal investigator on the Phase 2 grant.

“The phase 2 project costs significantly more money and is investigating the biosafety of the liver and heart in various animal models after longer treatment periods,” said Amin. “These studies focus on good manufacturing practice facilities. In addition, Phase 2 grants include a large business component focused on evaluation by major biopharmaceutical companies with neuroscientific drug discovery scientists.”

The study’s small business partner, Oleolive, is a biopharmaceutical company based in Shreveport, Louisiana. Oleolive has experience in developing and commercializing potential therapeutics for various diseases.

“Oleolive is focused on building the business component of the application,” Amin said. “This helps to understand the value of the candidate drug as it develops into a new drug review application with the FDA. In addition, they also collect all the information required for the application requirements, including safety and bioavailability.”

With all the work to bring AU9 to this point in the process, Amin is grateful for the support and opportunities at Auburn and Harrison College of Pharmacy to design and develop such a novel drug.

“We in the drug research and development department are fortunate to have human resources and equipment available for the discovery, design and development of novel drugs for various diseases,” said Amin. “I truly appreciate the tremendous support from the department, college, Deanery and Auburn University which enables us to compete at the highest level in the field of drug discovery.”

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