Veyonda® COVID-19 Study Approved For Immediate Start

Sydney, 1 September 2020: Australian drug development companyNoxopharm Limited (ASX: NOX)
today announces the commencement of a clinical study of Veyonda® in COVID-19 patients.
Following review by expert panels, official approval has been granted for immediate commencement of the Phase 1 NOXCOVID-1 study.

This is an important milestone for the Company. It also represents an important medical milestone in being the first known use of a drug in COVID-19 patients that inhibits a target (STING pathway) increasingly being incriminated as a leading cause of death and long-term disability in
these patients.

Noxopharm has previously (19 Jun 2020, 21 Apr 2020, 1 Apr 2020) provided information on
Veyonda® and what it believes to be its potential to prevent the progression of COVID-19 disease
via the STING pathway into the phenomenon known as a ‘cytokine storm’ leading onto septic

The NOXCOVID-1 study
NOXCOVID-1 will involve approximately 40 COVID-19 patients in hospitals in Ukraine and
Moldova, two countries currently experiencing high rates of infection and hospitalisation.

A range of doses of Veyonda® will be administered to patients hospitalised with moderate
symptoms who are at high risk of tipping over into a cytokine storm and developing septic shock.
Typically, these patients are sick enough to require hospitalisation, but do not yet have such
severe symptoms that they require ICU care or mechanical ventilation.

Patients will be treated with Veyonda® for at least 14 days and may receive treatment for up to
28 days if required. The safety and tolerability of the medication in patients with poor lung
function will be measured, as well as the drug’s ability to prevent patients progressing into a
cytokine storm and septic shock. One of the key endpoints is the effect of treatment on blood
cytokine levels, which will be assayed in an Australian laboratory.

Training of the medical personnel at the study sites has been completed and now that approval
has been granted, supplies for the study are being shipped without delay. The study will
commence immediately and patients will be enrolled until late-October 2020. Findings of the
study are anticipated to be released in early-2021.

Dr Gisela Mautner, Noxopharm Chief Medical Officer, said: “This is an important step in
potentially bringing to market a medication that could reduce the devastating worsening lung
function and multi-organ failure that afflicts a number of COVID-19 sufferers. There is growing
scientific evidence that excessive STING signalling is behind the cytokine storm causing severe
disease and even death in COVID-19 patients. Therefore, the Company is excited to be in a
position to put this theory into practice and hopefully help to reduce the terrible impact of this

Graham Kelly, Noxopharm CEO, said: “Increasingly it looks likely that the world is going to have
to learn to live with the SARS-CoV-2 virus, including needing to have effective therapies to deal
with the 5% or so of patients who contract the virus and whose lung failure puts them at risk of
developing a cytokine storm and its associated serious clotting disorders. The upcoming
NOXCOVID-1 study potentially could position Veyonda® as a front-line therapy for those patients,
irrespective of whether an effective and safe vaccine is developed.”

The Company will consider its next step after reviewing the final NOXCOVID-1 data. Noxopharm
remains in discussion with the U.S. FDA on conducting a clinical study in the U.S., with
NOXCOVID-1 serving as a pilot, proof-of-principle study.

About Noxopharm
Noxopharm Limited (ASX:NOX) is an Australian clinical-stage drug development company focused on the treatment of cancer and septic shock.
Veyonda® is the Company’s first pipe-line drug candidate currently in Phase 2 clinical trialling. Veyonda® has two main drug actions – inhibition of sphingosine kinase and inhibition of STING signalling. Activity against the former target contributes to its dual-acting oncotoxic and immuno-oncology functions designed to enhance the effectiveness and safety of standard oncology treatments, i.e., chemotherapy, radiotherapy and immune checkpoint inhibitors. Activity against the latter target provides an anti-inflammatory effect, also contributing to an anti-cancer action, but also potentially blocking sepsis. Noxopharm also is the major shareholder of US biotechnology company Nyrada Inc (ASX:NYR).

About Veyonda® and cytokine storm
Idronoxil, the active ingredient in Veyonda®, blocks the STING signalling pathway5. This immune pathway is induced upon lung damage,6 and is responsible for triggering the production of a range of cytokines, including IL-6, IL-10 and IP-10, which are responsible for the cytokine storm which can lead to septic shock and potentially death.

Media Enquiries
Julia Maguire
The Capital Network
T: + 61 2 8999 3699

Related Posts

Subscribe Our Newsletter