Boryung Completes Phase 2 Trial Enrollment
Boryung has completed patient enrollment for Phase 2 clinical trials of 'Bersomolisib (BR101801),' a next-generation anticancer drug candidate that is the world's first to simultaneously inhibit PI3K gamma (γ), PI3K delta (δ), and DNA-PK, substances that cause hematologic malignancies.The company sa
Boryung has finalized enrollment for Phase 2 trials of Bersomolisib (BR101801), a pioneering anticancer drug candidate that simultaneously inhibits PI3K gamma, PI3K delta, and DNA-PK. The company announced on October 19 that it had reached the target of 44 patients, seven months after the first dose in March. This rapid enrollment is notable given the challenge of recruiting participants for trials of rare blood cancers.
The ongoing Phase 2 study, conducted at 17 Korean institutions, aims to assess the drug's efficacy and safety through monotherapy. Bersomolisib, a first-in-class drug, targets three pathways crucial for cancer cell growth, survival, and DNA repair. Early Phase 1 results showed promising objective responses in six out of 19 patients, with four achieving complete responses and some patients demonstrating long-term efficacy.
Bersomolisib has earned orphan drug status from the U.S. FDA and Korea's Ministry of Food and Drug Safety, and has been designated as a rare disease drug in Korea, allowing conditional approval after Phase 2. Boryung aims to complete Phase 2 by 2028, following a year of post-treatment observation, with the goal of obtaining marketing authorization to expedite commercialization.
The company's CEO, Kim Jeong-gyun, emphasized Bersomolisib as a testament to Boryung's research and development prowess and highlighted the drug's potential to provide a new treatment option for patients with peripheral T-cell lymphoma.
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