November 29, 2022
AUBURN, Alabama – With a novel approach to treating Alzheimer’s disease, the Harrison College of Pharmacy’s Raj Amin is partnering with the biopharmaceutical company Oleolive to further advance the candidate drug in 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 in the Department of Drug Discovery and Development, and collaborators who include 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 aid in commercialization of the compound, Auburn’s technology transfer office, known as The IP Exchange, applied for and obtained a U.S. Patent.
The compound, referred to as AU9, is an intellectual property made and designed at Auburn and the Harrison College of Pharmacy.
“I am very excited about the abilities the NIH gives to us to advance our studies and allow us to proceed with a possible Investigational New Drug application to the Food and Drug Administration,” said Amin. “Our abilities to design and develop novel therapeutics at Auburn in the Department of Drug Discovery and Development will allow us to advance the field of drug discovery related to fighting Alzheimer’s disease.”
AU9 is a novel drug that activates the nuclear receptor peroxisomal proliferator, activating receptor delta and partially gamma, also referred to PPAR delta and gamma.
The in silico design and development of AU9, meaning it was designed and developed by computer simulation, induces the expression of neurotrophins that act to improve synaptic plasticity and memory while separately reducing inflammation associated with the progression of the disease.
“Our drug candidate is unique because it has been designed in silico to activate the nuclear receptor PPAR,” said Amin. “This is a very exciting and promising field with lots of challenges and opportunities to explore, including considerable testing needed for evaluating the safety, efficacy and bioavailability this substance.”
Early research was supported by an NIH R15 grant awarded to Amin and Vishnu Suppiramaniam, Gilliland Professor in the Harrison College of Pharmacy, focused on understanding how AU9 improves behavioral deficits and neuronal function in animal models of Alzheimer’s disease.
After successful completion of this study, Amin partnered with Oleolive for continued work on the drug. To enable commercial development of AU9 and strengthen pursuit of small-business funding, 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 where they learned more about the bioavailability of the drug in the brain, as well as 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 institutions. Rusty Arnold, a professor in the Harrison College of Pharmacy, is a co-principal investigator on the phase 2 grant.
“The phase 2 project is considerably more money and investigates in different animal models the biosafety for the liver and heart after extended treatment periods,” said Amin. “These studies focus upon good manufacturing practice facilities. In addition, phase 2 grants carry a large business component that focuses on evaluation from large industry-type biopharmaceutical companies with scientists in the neuroscience drug discovery field.”
The small business partner in the study, Oleolive, is a biopharmaceutical company based in Shreveport, Louisiana. Oleolive has experience in development and commercialization of potential therapeutics for various diseases.
“Oleolive is focused on building the business component of the application,” said Amin. “This helps to understand the value of the candidate drug as it progresses towards an Investigational New Drug Application to the FDA. In addition, they also collect all information needed for the requirements for application, including safety and bioavailability.”
With all the work to get AU9 to this point in the process, Amin is thankful for the support and opportunities at Auburn and the Harrison College of Pharmacy to design and develop such a novel drug.
“We are fortunate in the Department of Drug Discovery and Development that personnel and equipment are available for the discovery, design and development of novel drugs for various diseases,” said Amin. “I sincerely appreciate the tremendous support from the department, the college, the dean’s office and Auburn University that allows us to compete at the highest level in the field of drug discovery.”
Auburn University’s Harrison College of Pharmacy is ranked among the top 25 percent of all pharmacy programs in the United States, according to U.S. News & World Report. Fully accredited by the Accreditation Council for Pharmacy Education (ACPE), the College offers doctoral degrees in pharmacy (Pharm.D.) and pharmaceutical sciences (Ph.D.) while also offering a master’s in pharmaceutical sciences. The College's commitment to world-class scholarship and interdisciplinary research speaks to Auburn's overarching Carnegie R1 designation that places Auburn among the top 100 doctoral research universities in the nation. For more information about the College, please call 334.844.8348 or visit http://pharmacy.auburn.edu.