COVID-19: Novel Coronavirus

We have a unique opportunity to contribute to the global challenge posed by coronavirus and other viruses threatening our communities. The active compound in WP1122 was found to reduce in vitro replications of SARS-CoV-2 by 100%.

1: as of 4/25/21

Tackling Coronavirus with WP1122

Moleculin has a unique opportunity to contribute to the global challenge posed by coronavirus and other viruses threatening our communities.  We announced a collaboration with a major Texas university institution to evaluate our drug candidate, WP1122, and its analogs and this has now been followed by collaborations with additional players who bring the needed expertise to fully develop this new potential treatment for diseases like COVID-19.

Preclinical Data

  • Multiple independent University studies show antiviral activity of 2-DG against SARS-CoV-2
  • 2-DG was just given Emergency Use Authorization for treating COVID-19 in India based on Phase 2 results1
  • WP1122 has substantially higher in vitro antiviral activity than 2-DG
  • Pre-Assessment meeting with MHRA supportive of initiating Phase 1 HV trial in UK in H2 2021

Next Steps

  • Initiation of Phase 1a/1b study targeted in H2 2021
  • Potential to launch Phase 2 pivotal study in H2 2021

1: Based on public disclosures of trial conducted by an unrelated company in India

Independent researchers at the Institute of Biochemistry II – Goethe-Universität Frankfurt in Germany announced their discovery that 2-DG, the active compound in WP1122, reduced in vitro replication of SARS-CoV-2 by 100%.   

Based on preclinical data, we have reason to believe that WP1122 may be effective against COVID-19. This is based on the vital roles that glucose plays in the proliferation of SARS-CoV-2. Viruses like SARS-CoV-2 place increased demand on glucose and upregulate their host cell’s metabolic processes. Some of the most important of these processes are believed to be glycolysis and glycosylation.

Based on previously announced data demonstrating the antiviral potential of our lead antimetabolite molecule, WP1122, we intend to test the drug candidate for the potential treatment of COVID-19. Although we have previously disclosed that antiviral clinical trials in the US will be dependent upon demonstrating efficacy in an appropriate COVID-19 animal model, we recently engaged in discussions with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) regarding the potential for beginning clinical trials of WP1122 without the need for additional preclinical animal efficacy models. Based on our initial discussions with the MHRA, we believe that a COVID-19 animal model will not be required in order to submit a clinical trial application (CTA) for a Phase 1 clinical trial beginning with healthy volunteers in that country, although no final determination has been made by the MHRA. Based on this feedback, we intend to proceed with the submission of a CTA for a Phase 1 clinical trial of WP1122 in the UK.

The preclinical work to evaluate molecules within the WP1122 portfolio of antimetabolites (which include molecules capable of inhibiting glycolysis and altering glycosylation) for viral indications is mostly similar to the preclinical work we originally planned as part of developing WP1122 for cancer indications. Accordingly, we believe the preclinical work we have completed for WP1122 will also support an IND application or its equivalent in other countries for cancer-related clinical trials. We continue to plan to submit such an IND in the US in 2021.