AsianScientist (Aug. 26, 2011) – Israel-based D-Pharm Ltd. announced this week that the Korean Food & Drug Administration (KFDA) has approved the Investigational New Drug (IND) application for the Phase III MACSI study of DP-b99 in Korea.
The IND has been submitted by D-Pharm’s co-development partner in South Korea, Yungjin Pharmaceutical Company Ltd. (YJP).
DP-b99 is a unique broad-spectrum neuroprotective drug that addresses an array of brain damaging processes occurring in ischemic stroke patients. Both preclinical and clinical Phase I and II studies indicate a favorable efficacy and safety profile for DP-b99.
In the Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.
In 2006, D-Pharm granted an exclusive license to YJP to develop, register, and market DP-b99 in South Korea for treatment of patients with acute ischemic stroke.
To achieve KFDA approval of the IND application, YJP sponsored a pharmacokinetics and safety study of DP-b99, for the first time, in healthy Asian volunteers. The study was successfully completed early in 2011 and demonstrated no safety issues. The dosing regimen of DP-b99, intended for routine clinical use, yielded in Asian subjects a pharmacokinetic profile comparable to that in the corresponding Caucasian population.
Successful completion of the safety and pharmacokinetics study allowed YJP to gain KFDA approval to participate in MACSI.
Currently, the MACSI study, a randomized, double blind, placebo-controlled DP-b99 Phase III stroke study, is ongoing in over 150 clinical sites worldwide. YJP will sponsor the Korean part of the MACSI study. In the MACSI study, DP-b99 is being tested for safety and for the ability to improve outcome in moderately severe acute ischemic stroke patients. A total of 770 patients will be recruited.
“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,” said Dr. Alex Kozak, D-Pharm’s CEO.
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Source: D-Pharm.
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