NapaJen Pharma reports Phase 1 safety data for NJA-730 candidate
NapaJen Pharma has completed a Phase 1 clinical trial for its NJA-730 candidate, reporting no serious adverse events. The company intends to advance to Phase 2 trials in 2021 for the prevention of aGvHD.
NapaJen Pharma has announced the completion of its first-in-human Phase 1 clinical trial for NJA-730, a therapeutic candidate designed to treat acute graft-versus-host disease (aGvHD). The study, conducted in Australia with approximately 80 healthy volunteers, focused on evaluating the safety, tolerability, and pharmacokinetic profile of the drug.
The therapeutic combines an anti-CD-40 oligonucleotide with the company's proprietary beta-glucan delivery technology. This mechanism is intended to direct the drug to specific dendritic cells and macrophages, theoretically reducing off-target systemic side effects. Data indicated the compound was well-tolerated at doses up to 6 mg, with only mild or moderate adverse events recorded.
CEO Kenji Arima stated that the results provide essential validation for the company's oligonucleotide delivery platform. The company plans to proceed with a Phase 2 trial in 2021, targeting patients receiving hematopoietic cell transplantation in the United States and Australia.
aGvHD remains a significant risk for transplant patients, where donor lymphocytes attack host tissues. NapaJen’s ongoing research aims to mitigate this reaction through its targeted delivery approach, moving beyond the preliminary data observed in nonclinical models.