Company: TAK
Filing Date: 2025-09-08
Form Type: 6-K
Source: 0001395064-25-000130
Chunk: 3

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-09-08
Form: 6-K
Chunk 3
---
LTE) study.

The oral presentations at World Sleep include data from objective and patient-reported measures of wakefulness, cataplexy, symptom severity and quality of life, including 2,3,4,5 :

•

#### Wakefulness
: Oveporexton improved excessive daytime sleepiness demonstrating statistically significant improvement from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) and in Epworth Sleepiness Scale (ESS) scores at week 12 across doses compared to placebo. The majority of participants treated with the 2/2mg dose achieved wakefulness within normative range (≥20 min) on the MWT, and close to 85 percent of participants achieved ESS scores comparable to healthy individuals (≤10).

•

#### Cataplexy
: Oveporexton demonstrated significant reduction in weekly cataplexy rate over 12 weeks across doses compared to placebo (median of percent change from baseline more than 80%). Median cataplexy free days compared to placebo improved from 0 days at baseline to 4-5 days per week at week 12. Cataplexy is a defining symptom for NT1 and is the sudden loss of muscle tone triggered by strong emotions.

•

#### Symptom Severity
: Oveporexton showed statistically significant changes from baseline in the narcolepsy severity scale (NSS-CT) total score compared to placebo with more than 70 percent of participants reporting the lowest severity level (mild; score 0-14) across doses. Oveporexton also resulted in statistically significant improvements in overall narcolepsy symptoms as assessed by the self-rated Patient Global Impression of Change (PGI-C) scale with nearly all treated participants (97%) reporting improvements.

•

#### Quality of Life
: Oveporexton resulted in statistically significant improvements in quality of life reaching scores in the normative range as assessed by the Short Form-36-item (SF-36) survey. These outcomes were supported by significant improvements on exploratory endpoints including the EuroQol 5-Dimension 5-Level (EQ-5D-5L).

•

#### Safety Profile
: Across both studies, oveporexton was generally well-tolerated. No treatment-related serious adverse events were observed. Consistent with our experience from previous clinical studies, the most common adverse events were insomnia, urinary urgency and frequency. Most adverse events were mild to moderate.

“We are leveraging our leadership in orexin science