Peptron said it would complete the phase-2 trial of Parkinson’s disease treatment candidate PT320 by April 2022, drawing attention to whether it would get the results in time.

On Monday, the company said that it would finish the 48-week administration of the experimental treatment for all the participating patients by the end of 2021, have a 12-week break to confirm the “disease-modifying effect,” and end the study by April 2022.

PT320 is a glucagon-like peptide-1 (GLP-1) receptor agonist, and Peptron expects that the treatment could protect nerve cells.

Peptron’s phase-2 study of PT320 occurs at five local hospitals – the Seoul National University Hospital, SNU Bundang Hospital, Seoul Metropolitan Boramae Hospital, Asan Medical Center, and Samsung Medical Center. The company has finished recruiting 100 patients and began the investigational treatment for all patients.

Peptron received the Ministry of Food and Drug Safety’s approval in January 2015 to conduct the phase-2a study of PT320.

In February 2019, the company said the regulator authorized a change in the phase-2 trial plan. The company obtained the nod for producing clinical trial samples at its GMP factory in Osong, North Chungcheong Province.

The company began the first administration in the phase-2a study in March 2020.

Suppose Peptron completes the trial in April 2022. In that case, it will have taken seven years to wrap up the study after approval for the trial plan.

“After the first approval for the phase-2 trial, we built a production facility for trial samples and changed the trial plan. Changes in the study plan aimed to secure clinical and statistical significance,” an official at Peptron said.

“The two issues have been resolved, and we completed patient recruitment. We will be able to complete the study as scheduled.”

Peptron said it confirmed PT320’s therapeutic effect in a progressive Parkinson’s disease animal model and published the study in ACS Pharmacology & Translational Science.

Peptron, the U.S. National Institutes of Health (NIH), Mayo Clinic Hospital, and Taiwan's National Defense Medical Center used a MitoPark transgenic animal with the impaired mitochondrial function of dopamine neurons to induce the progression of Parkinson's disease.

After administering PT320, the research team analyzed various parameters such as behavior patterns, PET scans of brain tissues, and the ability to recover dopamine secretion.

The researchers confirmed PT320’s efficacy, according to Peptron.

Previously, Peptron confirmed PT320’s brain cell regeneration effect in an existing neurotoxin-induced animal model.

As the treatment candidate showed its potency to block the progression of Parkinson’s disease in a transgenic animal model, PT320 will provide a treatment strategy, especially for early-stage Parkinson’s disease patients, Peptron said.

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