Peptron said on Wednesday that it failed to secure statistical significance of the primary endpoint for its Parkinson’s disease treatment candidate (PT320) in phase 2a clinical trials but will continue developing the drug.

Parkinson's patients at five hospitals including Seoul National University Hospital, Seoul Asan Hospital, and Samsung Medical Center were randomly assigned to test group 1 (PT320 2.0 mg), test group 2 (PT320 2.5 mg), or placebo group and administered the drug for 48 weeks, with an additional 12-week follow-up.

The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 score, an index for evaluating motor symptoms of Parkinson's disease, was the primary endpoint of the clinical trial. 

According to the public disclosure, there was no statistical significance between test group 1 and the placebo group for the mean change of MDS-UPDRS part 3 score (p=0.7355). Similarly, when comparing test group 2 and the placebo group, although the motor symptoms improved in test group 2, there was no statistical significance between the groups (p=0.5042).

Meanwhile, secondary outcomes like the K-PDQ-39 score, an indicator for evaluating the quality of life such as daily living ability, showed a statistically significant improvement compared to the placebo group.

Additionally, follow-up observations conducted for 12 weeks demonstrated that the UPDRS part 3 score remained higher than that of the placebo group. In particular, the treatment effect analyzed for patients with severe symptoms among early Parkinson’s patients were statistically significant (p=0.0110).

Regarding safety, no adverse drug reactions were reported.

"The small number of patients, decrease in medication adherence due to self-administration, and reduction in symptom differences from the placebo group, all contributed to poor results in securing statistical significance," said clinical advisors, Professor Foltynie of UCL and Professor Doo-Sup Choi at Mayo Clinic. "We are confident we can increase the likelihood of success by increasing the cohort size and introducing easy-to-administer prefilled syringes."

"We believe PT320's insulin resistance-improving mechanism can be a fundamental treatment for degenerative brain diseases and will continue working on a treatment for Parkinson's disease," a company official said.

They added that the company will also discuss licensing with overseas partners who are currently pursuing technology transfers.