Brisbane-based Zucero Therapeutics has announced what it describes as 'promising' laboratory-based findings for its lead clinical candidate pixatimod and COVID-19.
The company said pixatimod was originally developed for infectious disease and cancer. It is a first-in-class innate immunomodulatory small molecule that has been tested in Phase 1 clinical oncology studies in 83 patients to date.
Zucero said it made the decision earlier this year to pursue a dual-track antiviral/oncology development pathway for pixatimod.
The company announced plans on 20 March 2020 to undertake investigations on the antiviral properties of pixatimod in relation to COVID-19.
It said it has been working with national and international academic collaborators who have been assessing pixatimod’s antiviral properties, including in a number of in vitro live virus infectivity studies.
The company said, "Zucero is now pleased to advise the in vitro studies clearly demonstrated that pixatimod binds directly to the SARS-CoV-2 spike protein S1 receptor binding domain (RBD) which alters its conformation, a finding that confirms predictions from in silico modelling data.
"Moreover, a number of independent laboratories used different methods with different SARS-CoV-2 isolates to report the effective concentration of pixatimod required to block host cell infection of live virus by 50% (EC50)."
Zucero chief scientific officer Dr Keith Dredge said, “These robust and reproducible results highlight a new therapeutic approach to directly inhibit the SARS-CoV-2 virus and clearly support further testing of pixatimod for use in the treatment and prevention of COVID-19.”
Pixatimod is currently in Phase 1b clinical trials for advanced cancer in Australia. Pixatimod was also recently selected as a 'Priority Group 1' asset for laboratory testing by the CSIRO and Doherty Institute as part of the SARS-CoV-2 Antiviral and Antiseptic Screening Program. The company said it is currently in contract discussions with the CSIRO relating to this testing program.
Zucero also announced it is a recipient of the Therapeutic Innovation Australia voucher-based scheme designated Pipeline Accelerator COVID-19. This will co-fund bioanalytical and pharmacokinetic studies by TetraQ, which is at The University of Queensland, to support the progression of pixatimod for COVID-19.
“In this rapidly changing environment, Zucero has responded quickly and is applying its internally-designed, proprietary innovative technology to address this global public health challenge with very encouraging results,” said Zucero’s chairman Chris Burrell.
“On the back of this new COVID-19 data and the emerging data from our Phase 1b oncology trial, we are seeking to accelerate our antiviral and oncology development programs with the aim of initiating Phase 2 clinical trials in the US later this year.”