Peptron said Monday that the Ministry of Food and Drug Safety has approved its revised phase 2 clinical trial plans of PT320, a Parkinson’s disease treatment candidate.
PT320 is a GLP-1 receptor activator, a type of incretin hormone, which is likely to become a therapeutic drug for Parkinson's disease as it has shown efficacy against central nervous system diseases.
Under the changed plan, the company will produce the candidate at its Osong plant, which received GMP approval from the ministry on Thursday. Peptron intends to develop new drugs from its production facilities for the clinical trial and final commercialization of the treatment.
The company expects to complete the trial by 2020 and will evaluate the efficacy and safety of PT320 for symptom improvement and Parkinson's disease inhibition in patients with early Parkinson's disease at the Seoul National University Hospital and Asan Medical Center.
To increase the chance of success, the company has recruited Professor Choi Do-seob of the Mayo Clinic, to participate in the clinical trial design.
“With Professor Choi’s participation, the clinical level has been improved to global standards, greatly enhancing the possibility of success in drug development,” a company official said.
The company expects that Professor Choi will play a key role in analyzing clinical outcomes, publishing papers and presenting the data using his collaborative research network consisting of leading experts from the U.S. National Institutes of Health, as well as close links with domestic clinical staff, the official added.
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