According to an announcement by D-Pharm Ltd., (TASE: DPRM), an IND application for a Phase III MACSI study of DP-b99 in Korea has received approval from the Korean Food & Drug Administration (KFDA). DP-b99, intended to treat patients with acute ischemic stroke, is being developed by D-Pharm in partnership with Yungjin Pharmaceutical Company Ltd. (YJP), which has submitted the IND. MACSI is a Phase III, randomized, double blind, placebo-controlled stroke study for DP-b99 that is conducted in 150 sites globally.
YJP was exclusively appointed by D-Pharm in 2006 for the development, licensing, and marketing of DP-b99 in South Korea. The IND application for DP-b9 received KFDA approval based on the results of an YJP sponsored pharmacokinetics and safety study in healthy Asian volunteers, which was successfully completed early in 2011 with no safety issues. The pharmacokinetic profile in Asian subjects due to the DP-b99 dosing regimen, intended for routine clinical use, was comparable to that in the corresponding Caucasian population. The Korean part of the MACSI study will be sponsored by YJP that was granted KFDA approval to participate in MACSI due to the successful completion of the safety and pharmacokinetics study.
D-Pharm’s CEO Dr. Alex Kozak remarked, “Success of the study in Asian volunteers and extension of MACSI to South Korea is of strategic value, paving the way for DP-b99 to reach vast Asian markets.”
About MACSI: The US FDA has awarded fast track designation to the DP-b99 development program. The MACSI protocol published in the International Journal of Stroke underwent the Special Protocol Assessment (SPA) procedure as agreed by the US FDA. The MACSI study aims to evaluate the safety and improvement outcomes of the use of intravenous 1.0mg/kg/day DP-b99 within 9 hours in patients with moderately severe hemispheric acute ischemic stroke. The study will enroll a total of 770 patients. The primary endpoint is determined by a modified Rankin Scale (mRS) score at day 90 that will be compared between treatment groups using a ‘shift’, or distribution, analysis.
About DP-b99: DP-b99 is a novel broad-spectrum neuroprotective drug intended for the treatment of stroke patients with a wide range of brain damaging processes. The safety and efficacy profile of DP-b99 has been established by both preclinical and clinical Phase I and II studies. DP-b99 caused a 2-fold recovery of patients in the Phase IIb trial involving 150 ischemic stroke patients. DP-b99 has a 9-hour therapeutic window for being administered.