STA cancer therapy progressing to late-stage COVID-19 trial

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Australian company Specialised Therapeutics Australia has updated on a trial of its cancer therapy APLIDIN (plitidepsin) as a potential treatment for COVID-19 infection.

APLIDIN is currently registered in Australia for the treatment of multiple myeloma. It is not yet reimbursed through the PBS.

Specialised Therapeutics Australia is commercialising APLIDIN under an arrangement with Spanish biopharmaceutical company PharmaMar.

PharmaMar has announced results of a phase one trial involving APLIDIN as a treatment for COVID-19 infection.

The company said the trial met its primary safety and secondary efficacy endpoints.

Trial participants - patients with COVID-19 admitted to hospital - were administered APLIDIN at one of three doses levels over three consecutive days. 

Their viral load was evaluated at the initiation of treatment and then on days four, seven, 15 and 30. 

PharmaMar said, "The study has demonstrated a substantial reduction of the viral load in patients between days 4 and 7 from starting the treatment, the average reduction of the viral load on day 7 was 50% and on day 15, 70%. More than 90% of the patients included in the trial had medium or high viral loads on beginning the treatment."

It added, "80.7% of patients have been discharged on or before the 15th day of hospitalization, and 38.2% before the 8th day (according to the protocol, they must be hospitalized for a minimum of 7 days). Furthermore, a remarkable correlation has been observed between the decrease in viral load, the clinical improvement and the resolution of pneumonia, as well as a drop in inflammation parameters, such as the C-reactive protein (CRP)."

The company said it will now initiate discussions with regulatory agencies to set the parameters for a phase three trial in patients with COVID-19 who require hospitalisation.

The CEO of Specialised Therapeutics Australia, Carlo Montagner, welcomed the trial outcome.

He said, "Australia is the only country in the world to have approved APLIDIN to date for relapsed refractory multiple myeloma patients.

"This compound has a novel mechanism of action and is under investigation as a potential therapy to treat COVID-19.

"We, along with our international partner PharmaMar, are highly encouraged by the data that has emerged from this Phase 1 study. STA will now support plans to progress to a Phase 3 investigation of Aplidin and are in discussion regarding the potential to include Australian sites."