Harbour BioMed, a global company specializing in the development of novel antibody therapeutics, has received Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) to test a COPD treatment that targets thymic stromal lymphopoietin (TLSP).
The company said in a news release that TLSP plays a critical role in triggering airway inflammation by activating immune responses that contribute to COPD progression. The drug, known as HBM9378/SKB378, is designed to inhibit the TLSP-mediated signaling pathway, aiming to reduce airway inflammation and improve lung function in patients with COPD.
“The regulatory clearance from the NMPA marks an important milestone in advancing our efforts to address significant unmet needs in immunological diseases,” said Jingson Wang, MD, PhD, founder, chairman and CEO of Harbour BioMed. “[The drug] represents a potential best-in-class, long-acting TSLP antibody with exceptional biophysical properties. We will continue exploring its potential to benefit patients worldwide.”
HBM9378/SKB378 (also known as WIN378) is a fully human monoclonal antibody generated from two heavy chains and two light chains (H2L2) as part of a proprietary platform called Harbor Mice. It inhibits the TSLP-mediated signaling pathway by blocking the interaction between TLSP and its receptor — a well-validated cytokine that plays a key role in the development and progression of various immunological conditions including asthma and COPD.
Harbour BioMed has completed a phase 1 clinical trial in China for the drug, with a phase 2 trial set to begin soon.
