By Fineline Cube 
Asieris Pharmaceuticals (SHA: 688176) presented Phase 1b trial data for APL-1401 in moderate-to-severe active ulcerative colitis (UC) at the 19th European Colorectal Congress (ECC 2025). The orally administered dopamine beta-hydroxylase (DBH) inhibitor demonstrated a favorable safety profile and positive efficacy signals within a 4-week treatment period.
Regulatory Milestone & Data Presentation
| Attribute | Details |
|---|---|
| Company | Asieris Pharmaceuticals (688176.SH) |
| Product | APL-1401 |
| Data Presentation | 19th European Colorectal Congress (ECC 2025) |
| Trial Phase | Phase 1b |
| Indication | Moderate-to-severe active ulcerative colitis (UC) |
| Administration | Oral |
Drug Profile & Mechanism of Action
APL-1401 is a potent and selective dopamine beta-hydroxylase (DBH) inhibitor with a novel mechanism for autoimmune diseases:
- Target: DBH, the sole enzyme catalyzing norepinephrine (NE) synthesis from dopamine (DA)
- Mechanism: Inhibition elevates DA levels and decreases NE levels
- Therapeutic Effect: Restores normal intestinal immune homeostasis
- Innovation: First DBH inhibitor in clinical development for ulcerative colitis
Phase 1b Clinical Results
| Endpoint | Result (120 mg dose group) | Clinical Significance |
|---|---|---|
| Safety Profile | Overall favorable, no serious adverse events (SAEs) | Well-tolerated, supports further development |
| Clinical Response Rate | 33.3% at 4 weeks | Positive signal in short treatment window |
| Histological Improvement Rate | 66.7% at 4 weeks | Strong tissue-level response suggests disease modification potential |
| Treatment Duration | 4-week cycle | Rapid onset of action vs. traditional UC therapies |
Market Context & Strategic Outlook
- Ulcerative Colitis Market: China UC prevalence exceeds 400,000 patients; market projected ¥8 billion by 2030
- Unmet Need: Limited oral options beyond 5-ASA, corticosteroids, and JAK inhibitors; DBH mechanism offers novel pathway
- Competitive Landscape: Dominated by anti-TNF agents (Humira, Remicade) and emerging JAK inhibitors; APL-1401 provides differentiated mechanism
- Development Path: Phase 2 trial planned for Q2 2026; potential for accelerated approval based on histological improvement data
- Global Potential: DBH inhibition may be applicable to other autoimmune diseases (Crohn’s, rheumatoid arthritis)
Forward‑Looking Statements
This brief contains forward‑looking statements regarding APL-1401 development timelines, clinical outcomes, and market potential. Actual results may differ due to clinical, regulatory, and competitive uncertainties.-Fineline Info & Tech