Abion Nears Completion of Patient Enrollment for Babamakeup Phase 2 Trial... "Pursuing FDA Accelerated Approval"

Abion announced on the 17th that patient enrollment for the Phase 2 clinical trial of Babamekip (ABN401) has entered its final stage. The company plans to rapidly recruit the target number of 40 patients and pursue conditional approval from the Korea Ministry of Food and Drug Safety (MFDS) as well as accelerated approval from the U.S. Food and Drug Administration (FDA).

The company stated, "After enrolling around 10 patients at the end of last year, the number of patients has rapidly increased over the past six months," adding, "Once 40 patients are recruited and efficacy data is secured, we plan to discuss conditional approval with the MFDS."

Earlier, Abion presented the cutoff data from the Phase 2 clinical trial of Babamekip at the Industry Expert Session (IET) of the American Society of Clinical Oncology (ASCO) held earlier this month. At the time of the IET presentation, 34 patients had been enrolled, and the incidence of Grade 3 or higher treatment-related adverse events (TRAE) for Babamekip was reported at 10%. In comparison, the Grade 3 or higher adverse event rates for the FDA-approved competing drugs capmatinib and tepotinib were 38% and 28%, respectively, showing a difference of about 3 to 4 times compared to Babamekip.

An Abion representative said, "The competing drugs received accelerated approval from the FDA after enrolling around 80 patients," and added, "The Grade 3 or higher adverse event rate of Babamekip, which is only about one-third that of the competing drugs, increases the possibility of FDA accelerated approval."

They continued, "If Babamekip is approved by the MFDS and the U.S. FDA, it will become the second globally developed lung cancer drug from Korea following Yuhan Corporation’s Lazertinib," emphasizing, "We will strive to have the high value of our pipeline recognized based on the efficacy demonstrated in global clinical trials."

Meanwhile, Babamekip’s objective response rate (ORR) reached 54%, and median progression-free survival (mPFS) was 11.6 months. The company explained that this mPFS figure is as of June 9 and is expected to increase as the clinical trial progresses.