Samjin Pharmaceutical Co., Ltd. announced on Wednesday that it has submitted a clinical phase 1 trial plan for SJN314, its key new drug research pipeline targeting immune and inflammatory diseases, to the Food and Drug Administration (FDA).
SJN314 is an oral small molecule MRGPRX2 inhibitor aimed at treating various inflammatory conditions, including chronic spontaneous urticaria and atopic dermatitis.
Samjin Pharmaceutical has methodically established the drug’s mechanistic validity and potential efficacy through preclinical research projects backed by the Korea Drug Development Fund (KDDF).
MRGPRX2 is a receptor that plays a role in mast cell activation via the non-IgE pathway. It has emerged as a promising new treatment option for patients who don’t respond well to existing antihistamines or IgE-based therapies.
Recently, major pharmaceutical companies have been advancing clinical development and technology transfer deals for MRGPRX2 target pipelines. As interest in early-stage clinical data for non-IgE pathway therapies grows, SJN314 is attracting attention as a potential asset for global partnering discussions in its early clinical phases.
Responding to these global trends and potential partner requirements, Samjin Pharmaceutical has developed a strategy to verify the drug’s safety and pharmacokinetic properties in early clinical stages, paving the way for efficient progression to later phases.
The clinical trial will be conducted by the Clinical Pharmacology Research Team at Seoul National University Hospital. It aims to assess pharmacokinetic characteristics, safety, and tolerability in both Korean and Caucasian subjects. The trial design takes into account the possibility of demonstrating efficacy in early human studies, a crucial factor for global pharmaceutical companies considering technology transfers.
This strategic approach is significant as it creates a framework that could lead directly to global partnering discussions following phase 1 clinical trials.
Dr. Lee Soo-min, Director of Research at Samjin Pharmaceutical, stated that SJN314 is advancing to clinical trials based on data gathered through KDDF-supported preclinical studies. It has set global technology transfer and co-development as key objectives and plan to engage with potential partners from the early clinical stages.