US Phytotherapy Inc. (USPI) is developing natural, plant-based anti-viral agents, for the treatment of a number of viral infections, including, chikungunya, dengue, yellow fever, malaria and Zika virus infections. The company's development strategy is to generate drug candidates by analysing medicinal plants and extracting solutions for various conditions. The company has developed first in a series of new generation drugs using natural artemisinin and berberine to treat a range of mosquito borne viruses with no side effects. The lead compound of the programme, PROACT-D, is a patented plant based solution is being developed for the treatment of dengue and another lead compound PROACT-Z, is being developed to target zika infection. Preclinical development for the candidates is underway in the US.
As at May 2020, no recent reports of development had been identified for preclinical development in Chikungunya-virus-infections in USA, preclinical development in Dengue in USA, preclinical development in Malaria in USA, preclinical development in Yellow-fever in USA, preclinical development in Zika-virus-infection in USA.
Key Development Milestones
In August 2016, US Phytotherapy reported successful completion of preclinical studies on PROACT-D for the treatment of Dengue. The company plans to file IND to initiate phase I trials for Dengue in the first half of 2017. Prior to IND submission the company intends to collaborate with a contract research organisation (CRO) to perform final toxicity, pharmacokinetic, pharmacodynamic and metabolism studies in various animal species  .
In May 2016, US Phytotherapy reported that it was conducting preclinical in vivo studies and was in pre-IND discussions with the FDA. The solution demonstrated a dose-dependent inhibition of dengue virus infectivity in three distinctly different models of dengue virus infection. In preclinical studies (in-vitro and in-vivo in mice), PROACT-D demonstrated significant ability to treat dengue infection with an excellent safety profile and therapeutic activity at very low doses    .
In preclinical studies, PROACT-Z, demonstrated a dose-dependent inhibition of zika virus infectivity in preliminary cell culture studies using ZIKV FSS 13025. The IND-enabling studies are scheduled to be completed by the fourth quarter of 2016   .