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SyneuRx prepares for pre-phase-III meeting with FDA for its PentarlandirOct 26, 2022

Chairman of the Board of Directors of SyneuRx Corp., Mr Guochuan Tsai (蔡果荃), said that after the completion of the Phase II clinical trial of its new drug Pentarlandir for the treatment of mild diseases, the company will soon submit a pre-Phase III clinical consultation to the US FDA and will actively seek licensees to collaborate on the Phase III trial.

Tsai pointed out that since the virus cannot be completely killed, if the body's immune system overreacts, it will become an immune storm and further lead to organ failure.

The new drug, which can also be classified as a Chinese medicine as the raw material is plant-based, was also approved by the Singapore Health Sciences Authority today.

As planned by SyneuRx, a pre-phase III clinical trial consultation for Pentarlandir will be submitted to the US FDA in the near future, and it is expected to take as early as 60 days for the meeting to commence and discuss the direction of the clinical trial design. Vice President Snoopy Jiang (姜志翰) added that since the Phase III clinical trial is a multi-centre global trial, the overall cost is high, in addition to the potential for a 1,000-person enrollment, so the authorisation will be initiated to find a co-developer.

Jiang pointed out that he has already contacted four or five Chinese pharmaceutical companies and provided Phase II clinical data for Pentarlandir, while the US market continues to be approached, but the US pharmaceutical companies prefer to discuss further once they have complete data.

For more information please visit: www.syneurx.com