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July 13, 2021

GCAR to discontinue analysis of Amgen’s apremilast in REMAP-COVID trial

Apremilast was selected for the trial due to its potential to hinder inflammatory response caused by Covid-19.

Global Coalition for Adaptive Research (GCAR) has decided to stop the analysis of Amgen’s oral drug, apremilast (Otezla), in the REMAP-COVID clinical trial.

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Apremilast hinders the Phosphodiesterase 4 (PDE4) activity.

The drug was chosen for assessment as it is believed to potentially prevent inflammatory response linked to the signs, symptoms and pulmonary involvements seen in certain Covid-19 patients by regulating inflammatory cytokine production.

The randomised, embedded, multifactorial, adaptive platform REMAP-COVID trial is designed to evaluate various therapies for severe pneumonia in non-pandemic and pandemic settings.

Sponsored by GCAR in the US, REMAP-CAP swiftly pivoted to its pandemic mode in February last year.

The REMAP-COVID sub-study in the US analysed further potential therapies that selectively target SARS-CoV-2 and enrolled Covid-19 patients.

The global trial leverages an advanced design to effectively assess several interventions concurrently with therapies analysed within domains, depending on the pathway or action mechanism.

In REMAP-COVID, apremilast was tested within one of two domains assessing immune modulation.

GCAR noted that other treatments will continue to be assessed in this immune modulation domain of the trial.

The REMAP-CAP trial has so far enrolled more than 7,800 subjects at 323 sites in 22 countries to analyse 48 existing or completed interventions in 14 domains.

This trial is being carried out in partnership with Berry Consultants with support from various governments and non-profit organisations worldwide.

In January this year, GCAR commenced analysis of Kazia Therapeutics’ paxalisib and Kintara Therapeutics’ VAL-083 in GBM AGILE adaptive platform trial for newly-diagnosed and recurrent glioblastoma (GBM), a type of brain cancer.

The paxalisib arm was meant to enrol recently diagnosed unmethylated (NDUM) and recurrent GBM patients.

The VAL-083 arm was for NDUM and recurrent GBM patients and those with newly-diagnosed methylated MGMT.

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