S BioMedics announced on the 12th that it has released the topline results of the domestic Phase 1/2a clinical trial for its Parkinson's disease treatment candidate, 'A9-DPC (TED-A9)'. In this trial, no dose-limiting toxicity (DLT) was observed even in the high-dose group, successfully confirming the maximum tolerated dose (MTD).

[Clinical Trial Overview] This Phase 1/2a trial was a single-center, open-label, single-administration, dose-escalation study conducted on patients diagnosed with Parkinson's disease for more than five years. Approved by the Ministry of Food and Drug Safety (MFDS), the trial was conducted on a total of 12 patients at Severance Hospital, with the clinical trial period spanning from May 9, 2023, to December 10, 2025.

[Safety Assessment Results] The company stated that upon evaluating the low-dose group (3.15×10⁶ cells/body) and the high-dose group (6.30×10⁶ cells/body), no DLT occurred in either group. Consequently, the maximum tolerated dose (MTD) was determined to be the high dose of 6.30×10⁶ cells/body.

A total of 43 treatment-emergent adverse events (TEAEs) were reported across all 12 patients. However, all 43 cases were evaluated as unrelated to the investigational medicinal product, and there were 0 adverse drug reactions (ADRs). Serious adverse events (SAEs) occurred in 4 out of the 12 patients (33.33%), totaling 4 cases. Although this included one death case, the company evaluated it as unrelated to the cell therapy product. No serious adverse drug reactions (SADRs) were reported.

Not a single case of graft failure or rejection occurred among the patients. Bleeding was reported in one case involving one patient (16.67%) in the high-dose group, and there were no infection cases. One adverse event of special interest (AESI) involving death was also analyzed as unrelated to the drug.

[Exploratory Efficacy Assessment] The company explained that improvement trends were confirmed in the primary exploratory efficacy endpoints. 'MDS-UPDRS Total (Off)', a major motor symptom assessment metric, decreased from an average of 115.83 points to 86.20 points in the low-dose group, and from 121.00 points to 86.00 points in the high-dose group. 'MDS-UPDRS Part III (Off)' also improved from 61.00 points to 46.00 points in the low-dose group, and from 57.67 points to 39.17 points in the high-dose group.

In addition, the 'Hoehn & Yahr Scale (Off)' decreased from 3.67 to 2.60 in the low-dose group, and from 3.83 to 2.17 in the high-dose group. Improvement trends were also observed in some exploratory efficacy endpoints, such as 'PD Diary Off-time'.

[Future Plans and Investment Notices] S BioMedics plans to make additional disclosures as soon as it receives the Clinical Study Report (CSR). Furthermore, the company stated that it intends to establish a subsequent clinical development strategy based on these topline results and utilize the data for academic presentations, journal publications, and IR materials.

The company noted through its investment precautions that the statistical probability of the clinical trial drug receiving final medicinal product approval is known to be around 10%. Results may fall short of expectations during future clinical trials and product approval processes. There is also a possibility that commercialization plans may be altered or discontinued.

These results are based on clinical trial topline data, and some details may be modified or supplemented during the preparation of the final CSR, additional analyses, and regulatory review processes. The company evaluated the safety and exploratory efficacy through this trial and plans to continue with subsequent clinical development.