HONG KONG – South Korea's Peptron Inc. is looking to advance the development of sustained-release (SR) drugs, tapping into a global licensing deal with the U.S. NIH and focusing on developing new treatments for neurodegenerative disorders.

At the heart of the company's push is SR-exenatide, a GLP-1 receptor agonist that has the potential to treat neurodegenerative disorders such as Parkinson's and Alzheimer's diseases. It can cross the blood-brain barrier effectively and provide sustained release of the neuroprotective peptide to treat such diseases.

"The NIH has usage patent of GLP-1 for neurodegenerative diseases, and the new patent covers the sustained-release formulation for exenatide in [blood-brain barrier] delivery, so this exclusive license is essential to develop the exenatide as a commercial product," Hyosup Kim, director of business development at Peptron, told BioWorld Asia.

"We would lead this project to give a new treatment option for patients with Parkinson's disease and other neurodegenerative diseases," he added.

Focusing on peptide drugs, Peptron acquired the patent license from the NIH in 2014 to make it the only company allowed to develop GLP-1 receptor agonist as a drug for neurodegenerative diseases. The two signed the collaborative R&D agreement (CRADA) in the same year to work closely on more research.

To date, that exclusive license extends the usage of the SR-exenatide worldwide, which means Peptron would be the only company in the world developing it as a commercial product.

The SR-exenatide was not originally aimed at neurodegenerative disorders.

"Originally, we developed SR-exenatide as a type 2 diabetes drug (PT-302) and finished phase I and II clinical studies in Korea with Yuhan Corporation," said Kim.

A phase I study of PT-302 was completed in 2011, then a phase II study was done with diabetes patients at 15 hospitals in South Korea in collaboration with Yuhan Corp. A phase III trial was also completed to commercialize PT-302 for type 2 diabetes.

Meanwhile, the company is developing a once-monthly formulation known as PT-304.

"However, we got the first license agreement with the NIH in 2014, so we shifted the development direction to Parkinson's and neurodegenerative disease," said Kim.

That was when researchers at NIH discovered the novel use of exenatide in treating neurodegenerative diseases and registered the related patents in the U.S. and worldwide – hence Peptron's license agreement with the agency.

Peptron is in a good position to develop the drug. It recently raised $24 million through a convertible bond. The proceeds will be used in operating a GMP manufacturing facility, which was set to open last week, to produce clinical samples of SR-exenatide to prepare for global clinical studies, said Kim.

Kim also said Peptron has received IND approval for a phase II study in South Korea for Parkinson's disease.

Prior to the latest round, Peptron raised $35 million in 2016 to set up the manufacturing site, said Kim. "The additional funds this time will be used for doing clinical study and getting appropriate GMP certificate to produce its clinical sample. Also, we are evaluating additional studies for other neurodegenerative diseases. And Alzheimer or MSA [multiple system atrophy] will be possible options of studies to do."

According to the company, a number of studies have proposed GLP-1 receptor agonists as a new treatment for neurodegenerative diseases, including Parkinson's disease, Alzheimer's disease, Huntington's disease, traumatic brain injury, stroke and peripheral neuropathy.

"Neurodegenerative disorders, such as Parkinson's and Alzheimer's diseases, remain a great unmet medical need for millions of people around the world, and we are dedicated to innovating and advancing therapeutics for these life-altering diseases," said CEO Ho-Il Choi.

And Peptron is not stopping here.

"We are focusing on peptide drugs with sustained-release formulation, especially microsphere such as SR-octreotide and SR-leuprolide," said Kim. "Currently, SR-octreotide is preparing for a bioequivalent study to get the generic approval, while SR-leuprolide is already commercialized in Korea as Luphere."

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