#China #Chengdu #HBM9378 #Harbour BioMed #TSLP

Harbour BioMed's Phase I Clinical Trial of HBM9378

Harbour BioMed has recently unveiled the results of its Phase I clinical trial focusing on the antibody HBM9378, a groundbreaking treatment targeting thymic stromal lymphopoietin (TSLP). Conducted under the oversight of Dr. Min Xu at the Chengdu Fifth People’s Hospital, this study marks a significant advancement in the biopharmaceutical realm, particularly in the treatment of severe immunological disorders.

Study Overview

This first-in-human trial (NCT05790694/CTR20221961) was featured in the peer-reviewed journal Drug Design, Development and Therapy. The primary goals were to evaluate safety, tolerability, pharmacokinetics (PK), and immunogenicity. A total of 50 healthy adult participants took part in a randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study. Subjects were divided into cohorts and received various doses ranging from 20 mg to 900 mg of HBM9378, with two individuals receiving a placebo within each dose group.

Key Findings

The findings revealed a favorable safety profile for HBM9378. The overall incidence of treatment-emergent adverse events (TEAEs) was similar among those receiving the antibody and those on placebo, suggesting a low risk of increasing safety concerns with higher doses. Notably, the median time to reach maximum concentration (Tmax) varied between 4.05 and 14.1 days, with a mean half-life (T1/2) ranging from 55.0 to 65.8 days. This extended half-life is particularly promising as it might reduce the frequency of dosing required in future treatments, potentially improving patient adherence.

Interestingly, only 5% of participants developed anti-drug antibodies (ADA) during the study, with no clinical implications or noticeable effects on drug exposure. Importantly, no injection site reactions were reported among the groups.

Implications for Future Research

Harbour BioMed's CEO, Dr. Jingsong Wang, expressed excitement over the Phase I outcomes, stating, "The positive results for HBM9378 represent a significant step in our commitment to develop innovative therapies aimed at treating severe immunological conditions such as asthma and chronic obstructive pulmonary disease (COPD)." He highlighted the importance of these findings in reinforcing confidence in HBM9378's potential to fulfill unmet medical needs.

Dr. Min Xu, who led the study, noted, "Patients with severe immunological disorders could benefit significantly from treatments based on HBM9378. Its favorable pharmacokinetic profile demonstrates not only its tolerance but also its efficacy, setting the stage for advancing clinical development in this vital area of medicine."

As a potential best-in-class monoclonal antibody, HBM9378 holds promise for addressing diseases driven by TSLP, a key cytokine involved in diverse immunological conditions, including asthma and COPD. Its ability to be administered subcutaneously is another advantage, potentially enhancing patient experiences in treatment environments.

Next Steps in Development

The collaboration between Harbour BioMed and Kelun-Biotech—the co-developers of HBM9378—will continue as plans move forward for further clinical testing. The global Phase II POLARIS trial for HBM9378 has already been initiated by Windward Bio, which holds exclusive rights to the drug's commercialization outside of Greater China. Moreover, approval from the National Medical Products Administration (NMPA) in China has been secured for further studies focusing on treating chronic obstructive pulmonary disease.

Conclusion

The implications of HBM9378's Phase I trial results could be broad and transformative within the biopharmaceutical field and for patients suffering from severe immunological disorders. With ongoing research and promising early results, the future looks optimistic for expanding treatment options and improving clinical outcomes in these challenging health conditions.