Noxopharm has launched a clinical programme, called NOXCOVID, for its Covid-19 drug candidate Veyonda by starting a phase 1 trial in Europe.
According to the Australian clinical-stage pharma company, Veyonda has been designed to inhibit cGAS-STING signalling.
The drug candidate is being developed as a potential treatment of cytokine storm and septic shock that are considered to be among the main causes of morbidities and death in Covid-19 patients.
Veyonda’s objective, as per Noxopharm, is to block the onset of the cytokine storm which is known for causing tissue damage in the lungs and other major organs. The drug candidate is also being developed by the Australian drug maker as an adjunct therapy to radiotherapy in the treatment of prostate cancer.
Noxopharm said that Veyonda is not intended to replace other potential Covid-19 treatments such as dexamethasone that may offer a clinical benefit in patients with more advanced disease, who are already suffering from a cytokine storm.
Noxopharm CEO Graham Kelly said: “Septic shock is a lethal condition that occurs when the body experiences severe tissue damage associated with viral and bacterial infections and trauma. Instead of the body repairing the damage, the repair process goes into overdrive and the resulting excessive inflammatory and immune responses create even more damage.
“Apart from Covid-19 patients, septic shock is thought to be responsible for about ten million deaths worldwide every year, or one in five deaths. Covid-19 simply has brought to the fore the lack of an effective treatment for this very common but severe problem.”
NOXCOVID-1 is a phase 1 dose-escalation and dose-expansion study, which will focus on safety and proof-of-principle endpoints. The early-stage trial will feature up to nearly 40 patients who have been hospitalised due to respiratory insufficiency associated with the SARS-CoV-2 virus that causes Covid-19.
In April this year, the company said that laboratory studies indicated a mechanism of action of Veyonda’s active ingredient idronoxil is to stop the cGAS-STING signalling pathway. This includes STING and cytokine’s overexuberant response to the kind of hypoxic tissue damage related to low oxygen levels in patients suffering from Covid-19 and severe respiratory distress.
Noxopharm said that it is important to target the cytokine storm at its headwaters, thereby potentially modifying the production of the wide range of incriminating cytokines. The drug development company said that cGAS-STING pathway is increasingly being seen as the headwater.
Kelly added: “The purpose of this Phase I study is to test this theory in a clinical setting as quickly and as cost-effectively as we can.
“While Veyonda is first and foremost an anti-cancer drug, a successful treatment of septic shock represents both an enormous commercial opportunity and a pressing humanitarian need that we cannot ignore.”