Interim phase 1/2a study results positive for investigational Parkinson’s cell therapy

A South Korean biomedical company has announced positive 1-year assessment data from a phase 1/2a clinical trial of a human embryonic stem cell-derived midbrain dopaminergic progenitor for Parkinson’s disease.

In a press release, S.Biomedics said that the initial 3 participants in the 12-person study given a low dose (3.15 million cells) of the investigational therapy TED-A9 showed no infusion-related adverse effects on either MRI or CT.

Interim data further show that treatment led to a mean decrease from 61.7 at baseline to 49 in MDS-Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score at 1 year post-treatment, indicating significant improvement in motor function. Improvement was also observed in symptoms such as wearing off and freezing of gait, per the release.

The clinical trial, conducted at Severance Hospital of Yonsei University in South Korea, investigated safety and efficacy of TED-A9 on adults aged 50 to 75 years diagnosed with PD for more than 5 years and who exhibited motor complications such as freezing of gait or dyskinesia. Half of the participants were administered a low dose and the other half the high dose (6.3 million cells), with safety expected to be monitored for up to 5 years post-transplant.

“Importantly, the clinical results demonstrated very promising efficacy,” Dong-Wook Kim, MS, PhD, chief technology officer of S.Biomedics, stated in the release. “We are excited that TED-A9 could be a fundamental treatment that directly replaces dopaminergic neurons lost in patients with Parkinson's disease.”

The company additionally revealed in the release that further assessment data in the high-dose cohort is expected to be announced in September or October of 2024.