[Edaily Reporter SONG YOUNG-DOO ] S.Biomedics Co., Ltd.(304360)S.Biomedics Co., Ltd. has released the 24-month follow-up results from the Phase 1/2a clinical trial of its Parkinson’s disease cell therapy “TED-A9” and expressed confidence in its competitiveness compared to its global rival, U.S.-based BlueRock Therapeutics. S.Biomedics Co., Ltd. emphasized that, despite conducting the trial on patients with more severe conditions than those in BlueRock’s trial, it confirmed significant improvements in key motor function indicators and observed that the therapeutic effects continued to increase through the 24-month mark.

Kang Se-il, CEO of S.Biomedics Co., Ltd., said, “The results exceeded our expectations,” adding, “Although our patients’ baseline conditions were much worse than those in the BlueRock trial, the degree of improvement in motor function was greater, and most importantly, the key point is that the effects continued to improve over time.”

“Continuous Improvement Up to 24 Months”

TED-A9 is a cell therapy for Parkinson’s disease that involves the direct transplantation of stem cell-derived dopamine neuron precursors into the ventral midbrain region of patients. TED-A9 shares a similar mechanism of action and administration method with Bemdaneprocel (BRT-DA01) from BlueRock Therapeutics, a subsidiary of Bayer.

This clinical trial involved 12 patients who had been diagnosed with Parkinson’s disease for at least five years (six in the low-dose group, administered 3.15 million cells; six in the high-dose group, administered 6.3 million cells), and evaluated safety and efficacy for 96 weeks (24 months) following transplantation.

The most notable finding was that the therapeutic effect actually increased over time. Since Parkinson’s disease is generally a degenerative disorder characterized by progressive symptom worsening, the fact that the degree of motor function improvement increased over the long term suggests that the transplanted cells have stably engrafted and are continuing to function.

The MDS-UPDRS Part III (OFF) score, which assesses motor function, decreased by an average of 15.0 points in the low-dose group and 18.5 points in the high-dose group at the 24-month mark. In particular, the high-dose group showed a steady increase in the magnitude of improvement throughout the follow-up period, with a 15.5-point decrease at 12 months, a 16.5-point decrease at 18 months, and an 18.5-point decrease at 24 months. The MDS-UPDRS Total (OFF) score, which reflects the overall severity of Parkinson’s disease, also decreased by an average of 27.8 points in the low-dose group and 35.0 points in the high-dose group.

The Hoehn & Yahr Scale, which assesses the stage of disease progression, also showed improvement. At the 24-month mark, the low-dose group improved by an average of 1.0 stage, while the high-dose group improved by an average of 1.7 stages. Notably, the high-dose group—which had an average stage of 3.8 prior to treatment—began to improve 9 months after transplantation and remained stable through the 24-month mark.

The company explained, based on relevant literature, that the improvement in the Hoehn & Yahr Scale in the high-dose group corresponds to reversing approximately 7.7 years of disease progression on average. Given that Parkinson’s disease naturally worsens over time, this result is being interpreted as demonstrating the potential to not only alleviate symptoms but also to slow or reverse the progression of the disease itself.

Changes experienced by patients in their daily lives were also confirmed. Analysis of the Parkinson’s Diary (PD Diary) revealed that “OFF-time”—periods when medication efficacy wanes and movement is restricted—decreased by an average of 4.59 hours per day in the low-dose group and 2.78 hours in the high-dose group. Conversely, “ON-time”—periods when medication efficacy is stable—increased by 3.76 hours in the low-dose group and 4.77 hours in the high-dose group.

Although S.Biomedics Co., Ltd. acknowledges that these results are from an exploratory analysis, the company expects them to serve as meaningful indicators in future global clinical trials, given that they align with the key endpoints of the late-stage clinical trial currently under discussion with the U.S. FDA.

“Better Results in More Severely Ill Patients”… Differentiation from BlueRock

CEO Kang emphasized that attention should be focused on differences in patient populations and the sustainability of treatment effects rather than mere numerical values. He said, “Looking at the MDS, a motor function measure, BlueRock’s scores plateaued at 18 months, while ours continue to decline (improve). If you look at the scores at face value, it might seem like we lost, but our patients were much more severely affected.” He added, “There’s a difference of nearly 8 to 9 points, and we started from a worse baseline. The most important thing is that the trend continues to improve.”

In fact, the pre-transplant MDS-UPDRS Total (OFF) scores for participants in the TED-A9 clinical trial averaged 115.83 points in the low-dose group and 121.00 points in the high-dose group. With an average disease duration of over 10 years, these were severe patients who had suffered from the disease for a long time. At the 12-month mark, based on the MDS-UPDRS Total (OFF) score, TED-A9 recorded improvements of 12.7 points in the low-dose group and 15.5 points in the high-dose group, showing a greater improvement than BlueRock’s bemdaneprocel, which recorded 7.6 points in the low-dose group and 8.3 points in the high-dose group.

Looking solely at the 24-month MDS-UPDRS Part III (OFF) scores, which assess motor function only, the high-dose group of BlueRock (-21.9 points) showed a slightly greater improvement than the high-dose group of TED-A9 (-18.5 points). However, the company explains that a simple numerical comparison has its limitations, as the BlueRock trial targeted patients with moderate disease, whereas the TED-A9 trial focused on severe patients with a disease duration of 10 years or more.

Rather, the sustainability of the improvement pattern is cited as a more significant difference. The improvement in the MDS-UPDRS Part III score for the BlueRock high-dose group peaked at -23.0 points at 18 months, then decreased to -21.9 points at 24 months and -17.9 points at 36 months. In contrast, the TED-A9 high-dose group showed a trend of increasing improvement over time, with scores of -15.5 points at 12 months, -16.5 points at 18 months, and -18.5 points at 24 months.

CEO Kang emphasized, “While our U.S. competitor showed a slowing of improvement after 18 months, TED-A9 has continued to improve steadily through 24 months,” adding, “The fact that the improvement trend itself is continuing is the most important differentiator, and this suggests that the transplanted cells have engrafted over the long term and are continuously performing the functions of dopamine neurons.”

Based on these 24-month data, S.Biomedics Co., Ltd. plans to submit an Investigational New Drug (IND) application for a Phase 3 clinical trial to the U.S. FDA this year. The company has already completed a pre-IND meeting with the FDA and plans to finalize the late-stage clinical trial design through a Type C meeting in the near future. S.Biomedics Co., Ltd. is also conducting preliminary consultations with the Japanese regulatory authority (PMDA).

He said, “BlueRock is another example of a company that, based on early clinical data, consulted with the FDA and proceeded directly to late-stage clinical trials,” adding, “Since TED-A9 has secured competitive data in terms of efficacy and safety, we will actively pursue entry into commercial clinical trials in the U.S.”