ALK-Abelló ACARIZAX Phase 3 Trial Meets Primary Endpoint in China
ALK-Abelló A/S (OMXCOP:ALK_B) announced that its Phase 3 bridging trial in China for house dust mite allergy treatment ACARIZAX successfully met its primary endpoint. The trial, which included 327 participants over a period of 24 to 28 weeks, showed a 1.11 total combined response score difference compared to placebo, representing a 19.1% improvement. The treatment's safety profile remained consistent with results from previous clinical studies.
The positive outcome clears a key clinical hurdle for the company to expand into China's allergy treatment market. Following the announcement, Class B shares of ALK-Abelló A/S gained 2.46% to trade at 233 DKK. Management confirmed that its full-year financial outlook for 2026 remains unchanged, as the near-term financial impact is limited ahead of potential commercial entry.
Moving forward, ALK-Abelló plans to use the Phase 3 data to support a local regulatory application in China alongside its partner, GenSci. Investors will monitor the regulatory submission process and progress toward eventual market authorization and reimbursement.
Key points
- ALK-Abelló's Phase 3 bridging trial for ACARIZAX in China met its primary endpoint in house dust mite allergy.
- The study demonstrated a 1.11 score difference, or a 19.1% improvement over placebo, across 327 participants.
- Safety results were consistent with prior clinical trial data over the 24- to 28-week study duration.
- ALK-Abelló plans to submit a local regulatory filing in China with partner GenSci while keeping 2026 guidance unchanged.
- Shares of ALK-Abelló A/S Class B (OMXCOP:ALK_B) rose 2.46% to 233 DKK following the release.
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What were the key results of ALK-Abelló's Phase 3 trial in China?
The trial met its primary endpoint for ACARIZAX in house dust mite allergy, showing a 1.11 total combined response score difference (19.1% improvement) over placebo with a safety profile consistent with prior data.
What is the next step for ACARIZAX in China?
ALK-Abelló plans to use the Phase 3 trial findings to support a local regulatory filing for ACARIZAX in China in partnership with GenSci.
How did ALK-Abelló's stock react to the trial results?
Shares of ALK-Abelló A/S Class B (OMXCOP:ALK_B) rose 2.46% to 233 DKK following the trial update.