API
< Back to all clusters
[BUSINESS] · South Korea, United States · 4 sources

started · updated

Boryung completes Phase 2 patient recruitment for Bosmolisib cancer drug

Boryung has announced the completion of patient recruitment for its Phase 2 clinical trial of Bosmolisib (BR101801), a next-generation anticancer drug candidate. The trial targets patients with recurrent or refractory peripheral T-cell lymphoma (PTCL), an aggressive form of rare blood cancer for which standard second-line treatments are currently lacking.

Bosmolisib is a first-in-class triple inhibitor designed to simultaneously target PI3K gamma, PI3K delta, and DNA-PK, which are involved in cancer cell growth, survival, and DNA damage repair. The company completed the recruitment of 44 patients across 17 clinical sites in South Korea within approximately seven months of the first patient dosing.

Following a year of follow-up observations, Boryung plans to complete the Phase 2 trial by 2028 and subsequently apply for product authorization. The drug has already received orphan drug designation from the U.S. Food and Drug Administration (FDA) for specific PTCL subtypes, as well as orphan drug development status from South Korea’s Ministry of Food and Drug Safety.

Entities

Boryung · Bosmolisib · Ministry of Food and Drug Safety · U.S. Food and Drug Administration · World Health Organization