PhytoHealth (TWSE:4108), the first Taiwan Stock Exchange (TWSE), listed new drug development company, announced today that it has completed patient enrollment in its Phase II clinical trial of PHN081 (PDC-748), an antitussive new drug candidate. This Phase II trial was conducted at Chang Gung Memorial Hospital after the U.S. FDA’s approval to proceed the phase II clinical trial of PHN081 (PDC-748).

 

This Phase II trial is a randomized, double-blind, placebo controlled, dose escalating study. The purpose of this trial is to evaluate the safety and efficacy of the escalating dose levels of PHN081 (PDC-748) in patients with acute cough.

 

PHN081 (PDC-748) was developed from a single traditional Chinese medicine (TCM) plant which was applied for medicinal purposes with an established historical record of safe use. The pharmacological findings suggest that PHN081 (PDC-748) possess potent antitussive effect with a dose-responding manner. Furthermore, the Phase I//II trial has demonstrated the tolerance and safety of this new drug candidate.

 

PhytoHealth is preparing for the final report of this Phase II clinical trial and the End of Phase II meeting with the U.S. FDA. Furthermore, PhytoHealth also plans to advance PHN081 (PDC-748) into a pivotal Phase III clinical trial with U.S. FDA approval.