SunTen Phytotech (STPT), a research and development company of the Sun Ten Group, announced its latest new drug development progress: STD007 has been approved to launch First-in-Human (FIH) clinical trial in Taiwan by the Department of Health (DOH), Taiwan.

STD007 is a small molecular drug purified from commonly prescribed Chinese medicinal herbs for the treatment of inflammatory bowel disease (IBD).  The drug mechanism of STD007 is different to that of conventional drug treatment, STD007 can protect intestinal mucosa (thereby reducing the occurrence of ulcers) while reducing intestinal inflammatory reaction by inhibiting nuclear activation of the inflammatory initiating factor.  Animal pharmacological studies proved STD007 efficacy at 300 times that of sulfonamides, a western drug used for treating IBD.  Animal toxicity studies (required as part of pre clinical assessment) showed STD007 at high level of safety.

The timeframe of STD007 development from drug discovery to initiation of clinical trial was less than three years, a new record in terms of drug development in Taiwan.   STPT has chosen Taiwan as the site to implement FIH Phase I clinical trial.  This will also be the first small molecular drug discovered domestically that is allowed to conduct FIH clinical trial locally by the Taiwan DOH.  The next goal for STPT upon completion of Phase I clinical trial is to submit an Investigational New Drug (IND) application to the US FDA for Phase Ib/IIa clinical trials in the United States.  STPT is planning to proceed STD007 into global clinical trials next year.