{
  "id": 6537315,
  "title": "Harbour BioMed advances long acting antibody candidate to Phase 3 trial",
  "url": "https://urgent.news/2026/09/10/harbour-biomed-advances-long-acting-antibody-candidate-to-phase-3",
  "topic": "business",
  "section": "Business",
  "published": "2026-09-10T03:42:59.000Z",
  "source": {
    "name": "Vietnam Investment Review",
    "slug": "vietnam-investment-review",
    "url": "https://vir.com.vn/harbour-biomed-advances-long-acting-antibody-candidate-to-phase-3-trial-160393.html"
  },
  "original_language": "en",
  "account": "Cambridge, Massachusetts, Rotterdam, Netherlands, and Shanghai, September 8, 2026 /PRNewswire/ -- Harbour BioMed, a global biopharmaceutical firm, has announced that its collaborator, Windward Bio, has reported encouraging interim results from the Phase 2 POLARIS-1 clinical trial. The trial assesses twice-yearly dosing of HBM9378/WIN378, a novel ultra-long-acting monoclonal antibody. This groundbreaking drug, engineered to inhibit thymic stromal lymphopoietin (TSLP), showcases a unique binding mode to thwart TSLP signaling by targeting two distinct sites on TSLP, thereby affecting its interaction with both co-receptors on epithelial cells. POLARIS-1 is a comprehensive, global Phase 2/3 study presently in its Phase 2 portion, which is a randomized, double-blind, 48-week trial evaluating three dose levels of HBM9378/WIN378 against placebo. The Phase 2 evaluation focuses on pharmacokinetics, safety, immunogenicity, and pharmacodynamic activity, along with dose selection for Phase 3. The trial enrolled 147 patients, surpassing the initial target of 120 participants, with the interim analysis conducted on the first 98 participants. The interim findings revealed dose-dependent mean increases in FEV 1, a lung function indicator, of up to 174 mL (placebo-adjusted mean increase of 256 mL, p=0.033) and significant reductions in FeNO and blood eosinophil count (up to 24 ppb or -43%, p=0.006 and -51%, respectively), both of which are key markers of airway inflammation and exacerbation. HBM9378/WIN378 exhibited near-maximal effects as early as Week 2 and maintained these benefits through Week 24. Moreover, the drug demonstrated favorable safety results with no treatment-related serious adverse events, withdrawals, or discontinuations observed as of the study cut-off. Injection site reactions were rare (less than 1%), and 2% of participants developed anti-drug antibodies (ADAs), a measure of immunogenicity, which did not impact the drug's pharmacology. Harbour BioMed's CEO, Dr. Jingsong Wang, expressed optimism about the positive Phase 2 results and the drug's potential for twice-yearly dosing. The Phase 3 portion of POLARIS-1 will assess HBM9378/WIN378's impact on annualized asthma exacerbation rates in severe asthma patients, with two twice-yearly doses planned for this phase.",
  "summary": "Harbour BioMed announced positive Phase 2 clinical results for TSLP targeting antibody HBM9378 in asthma patients prompting partner Windward Bio to launch a Phase 3 study",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}