China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate ALMB-0168 in osteoarthritis. ALMB-0168, a connexin 43-targeted monoclonal antibody developed in-house by subsidiary AlaMab Therapeutics Inc., is under development to treat acute spinal cord injury, ischemic stroke, and many other neurological diseases.
Preclinical Data and Clinical Progress
A pre-clinical study has shown that ALMB-0166 can significantly reduce the pain of animal bones and joints, and improve the pathological condition of animal cartilage. The drug received an orphan drug designation (ODD) for use in acute spinal cord injury in the US in 2018. It concluded a Phase I study in Australia and initiated a Phase I/II study in China for the same indication.
Future Prospects and Strategic Implications
The NMPA’s approval to initiate the clinical study for ALMB-0168 in osteoarthritis marks a significant milestone in the development of this innovative drug candidate. CSPC Pharmaceutical Group’s commitment to advancing ALMB-0168 underscores its dedication to addressing significant unmet medical needs in neurological diseases and improving patient outcomes.-Fineline Info & Tech
