BioSig Technologies’ (BSGM -29.1%) majority owned subsidiary, ViralClear Pharmaceuticals has announced to increase the size of its Phase 2 trial of merimepodib in combination with remdesivir, from 40 to 80 subjects.
When the trial was first initiated, it was anticipated that COVID-19 hospitalized patients who require non-invasive ventilation (ordinal score of 3) and patients who require high flow oxygen devices and supplemental oxygen (ordinal score of 4) would have similar outcomes in terms of their disease.
However, based on a review of blinded data, subjects with scores of 3 and 4 showed distinct differences.
Subjects who were admitted with a score of 4 have had an uneventful course of disease and were discharged due to improvement in clinical condition.
Subjects with a score of 3 fared differently: one group improved and were discharged from the hospital, while others have not improved.
ViralClear decided to increase the enrollment with a focus on subjects with a score of 3 at entry.
Once additional subjects are enrolled and further clinical data is obtained, the company will discuss with the FDA the appropriate size for a Phase 3 trial.
ViralClear has also recruited a US-based contract manufacturer to manufacture the stability batches of merimepodib that will also serve as clinical trial supplies for the Phase 3 trial.
The company will conduct a merimepodib monotherapy trial in outpatient setting after current combination trial completes.
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