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Research programme: anti-viral therapeutics - US Phytotherapy

Drug Profile

Research programme: anti-viral therapeutics - US Phytotherapy

Alternative Names: PROACT D; PROACT-Z

Latest Information Update: 28 May 2020

At a glance

  • Originator US Phytotherapy
  • Class
  • Mechanism of Action
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • No development reported Chikungunya virus infections; Dengue; Malaria; Yellow fever; Zika virus infection

Most Recent Events

  • 28 May 2020 No recent reports of development identified for preclinical development in Chikungunya-virus-infections in USA
  • 28 May 2020 No recent reports of development identified for preclinical development in Dengue in USA
  • 28 May 2020 No recent reports of development identified for preclinical development in Malaria in USA

Development Overview

Introduction

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 [1] .

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 [1] [2] [3] .

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 [1] [2] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Chikungunya virus infections - - No development reported (Preclinical) USA unspecified / unspecified 28 May 2020
Dengue - - No development reported (Preclinical) USA unspecified / unspecified 28 May 2020
Malaria - - No development reported (Preclinical) USA unspecified / unspecified 28 May 2020
Yellow fever - - No development reported (Preclinical) USA unspecified / unspecified 28 May 2020
Zika virus infection - - No development reported (Preclinical) USA unspecified / unspecified 28 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
US Phytotherapy Originator USA
US Phytotherapy Owner USA

Development History

Event Date Update Type Comment
28 May 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Chikungunya-virus-infections in USA Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Dengue in USA Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Malaria in USA Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Yellow-fever in USA Updated 28 May 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection in USA Updated 28 May 2020
24 Aug 2016 Regulatory Status US Phytotherapy announces intention to file IND to US FDA for Dengue [1] Updated 26 Aug 2016
24 Aug 2016 Trial Update US Phytotherapy plans phase I trials for Dengue in USA [1] Updated 26 Aug 2016
20 Apr 2016 Phase Change - Preclinical Preclinical trials in Chikungunya virus infections, Dengue, Malaria, Yellow fever, Zika virus infection in USA (unspecified route) [2] Updated 19 May 2016

References

  1. US Phytotherapy Reports Successful pre-clinical testing of PROACT-D.

    Media Release
  2. US Phytotherapy Successfully Tests a Viable Treatment for Zika Virus.

    Media Release
  3. US Phytotherapy Reports Significant Efficacy in Initial Studies on Dengue Virus.

    Media Release
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