Prostemix Voluntarily Withdraws Phase 1 Clinical Trial Application for 'PSI-401'

[Asia Economy Reporter Junho Hwang] Prostemics announced on the 29th that it has voluntarily withdrawn its Phase 1 clinical trial application to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics after oral administration of PSI-401.

The company stated, "The time required for tests and analyses to submit supplementary materials requested by the Ministry of Food and Drug Safety is excessive, making it difficult to submit within the supplementary material deadline." It added, "Since PSI-401 is a new material called exosome and has never been approved for clinical trials in Korea, additional verification documents were expected to be continuously requested. We judged that the business feasibility was insufficient compared to the investment scale and that it would be difficult to expect the success of the clinical trial."

This content was produced with the assistance of AI translation services.