Announced details
Treatment of interstitial lung disease associated with systemic sclerosis (SSc-ILD)
Between-group difference in the mRSS slope over the 12- to 36-week interval: β = −0.049/week, p = 0.057. No significant incremental benefit was observed for %FVC, the primary endpoint
Enrollment of 50 patients was completed on 17 December 2024. Treatment of all patients was completed on 25 November 2025
Conducted an investigator-initiated clinical trial with a total of 12 sites, including Tohoku University, The University of Tokyo and Osaka University
A total of 12 sites, including Tohoku University, The University of Tokyo and Osaka University. Other information on location, representative, capital and year of establishment is Not disclosed
A total of 12 sites; enrollment of the planned 50 patients was completed as scheduled
No impact on results for the fiscal year ending March 2027 at present
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | PAI-1 inhibitor RS5614 |
| Counterparty | Tohoku University, The University of Tokyo, Osaka University |
| Counterparty overview | A total of 12 sites, including Tohoku University, The University of Tokyo and Osaka University. Other information on location, representative, capital and year of establishment is Not disclosed |
| Relationship with the Company | Conducted an investigator-initiated clinical trial with a total of 12 sites, including Tohoku University, The University of Tokyo and Osaka University |
| Launch date | October 2023 (trial initiated; actual) |
| Applicable area | Treatment of interstitial lung disease associated with systemic sclerosis (SSc-ILD) |
| Location scale | A total of 12 sites; enrollment of the planned 50 patients was completed as scheduled |
| Quantitative Effects | Between-group difference in the mRSS slope over the 12- to 36-week interval: β = −0.049/week, p = 0.057. No significant incremental benefit was observed for %FVC, the primary endpoint |
| Usage history | Enrollment of 50 patients was completed on 17 December 2024. Treatment of all patients was completed on 25 November 2025 |
| Impact on Business Performance | No impact on results for the fiscal year ending March 2027 at present |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The Company stated that no significant incremental benefit was observed for %FVC at Week 48, the primary endpoint. For mRSS, however, an additional analysis using a piecewise linear mixed-effects model based on longitudinal data from Weeks 0, 12, 24, 36 and 48 suggested a trend toward improvement over the 12- to 36-week interval. Regarding safety, the study drug was generally well tolerated, with no events that significantly deviated from the known adverse-event profile.