Samjin Pharmaceutical said on the 4th it has submitted an investigational new drug (IND) application to the Ministery of Food and Drug Safety for a phase 1 clinical trial of its immunology and inflammation treatment candidate "SJN314."
SJN314 is an oral small-molecule MRGPRX2 inhibitor targeting various inflammatory diseases, including chronic spontaneous urticaria and atopic dermatitis.
The target receptor MRGPRX2 is involved in mast cell activation through a non-immunoglobulin E (IgE) pathway. It is drawing attention as a new treatment option for patients who do not respond adequately to existing antihistamines or IgE-based therapies.
The clinical trial will be conducted by the clinical pharmacology research team at Seoul National University Hospital. It plans to evaluate pharmacokinetic characteristics, safety and tolerability in Koreans and white participants. It was designed with the potential for "proof of concept (PoC)" of efficacy in early human studies in mind.
Lee Su-min, head of the research center at Samjin Pharmaceutical, said, "We have set global technology transfer and co-development as key goals, and plan to pursue discussions with partners in parallel from the early clinical stages."