▲SP-8203 clinical study Ph.2a result announcement at 2018 European Stroke Organization Conference.

Shin Poong Pharm. Co., Ltd. announced the clinical trial phase 2a result of SP-8203 (Otaplimastat), a candidate drug for the acute ischemic stroke, at the 2018 European Stroke Organization Conference (hereinafter ESOC) in Gothenburg, Sweden May 16^th -18^th. ESOC along with International Stroke Organization Conference (hereinafter ISOC) is considered one of the most authoritative societies in stroke space. The content of presentation highlighted the figures from the phase 2a study; in order to confirm the safety and efficacy of SP-8203 in stroke patients, 80 patients were enrolled at 8 major university hospitals in South Korea (Stage1: 11 patients / single dose; Stage 2: 69 patients / double blind / randomized / 2 doses / placebo controlled). It has been being observed for 90 days after the administration of SP-8203 to which tPA was combined. There was no statistically significant difference in mortality or adverse events.

The speaker, Prof. Jong-sung Kim of Asan medical center in Seoul South Korea, noted that the safety of SP-8203 in stroke patients who agreed to receive tPA in the first place, or the ones getting the endovascular surgery with tPA has been confirmed through this clinical trial. In addition to the safety result, significant improvements in neurological disorders was checked by multivariate logistic regression analysis that calibrates age, sex, and time to administration of tPA after symptoms onset. The upcoming clinical trials (phase 2b) would be a turning point that puts SP-8203 at a vantage position. Also, he expressed expectations for potential as a first-in-class drug. 

It has proved that SP-8203 as a first-in-class candidate has a multiple neuroprotective effects through a variety of the stroke animal models. Particularly, because it extends the therapeutic window when combined with tPA, more patients would have the benefit of reducing cerebral infarction and edema as well as hemorrhage and mortality. In fact, a few years following by the project outset, SP-8203 won the top 10 future pharmaceutical special projects run by the Ministry of Health and Welfare, because it was highly evaluated for its distinctiveness, and it will have the supporting cash-in for the further clinical studies until 2020.

“Shin Poong Pharm. Co., Ltd. believes the safety and efficacy of SP-8203 has the feasibility to be proven clinically and statistically through upcoming clinical trial.” said Jei-man Ryu, the CEO of the company.

In addition, Shin Poong Pharm.Co., Ltd. plans to introduce the clinical results at the Bio International Convention held in Boston, USA from April 4 to 7 next month.