BioSig Technologies Inc (NASDAQ:BSGM) and its subsidiary ViralClear Pharmaceuticals Inc have decided to halt its Phase 2 coronavirus trial of merimepodib paired with remdesivir, the company announced Monday.
The study was expanded from 40 to 80 hospitalized COVID-19 patients, the company said, a decision that limited enrollment to NIAID Grade 3 participants, seriously ill patients who required high flow, high concentration oxygen. For that reason, the Safety Monitoring Committee (SMC) was unblinded, as these patients are at higher risk from dying from the coronavirus.
The most recent review of the data by the SMC found that 42 of the 44 patients enrolled in the trial received either merimepodib solution or a matching placebo. All 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37 day follow-up period.
READ: BioSig Technologies says subsidiary ViralClear Pharmaceuticals expanding drug development program to treat COVID-19
However, the 20 NIAID Grade 3 patients at the time of enrollment had markedly different outcomes, the company said.
Specifically, the unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib, making it unlikely that the trial would meet its primary safety endpoints. The company therefore elected to stop enrollment into the clinical trial.
Patients will be followed as per the protocol for safety monitoring, the company said, but no further study drug treatments will be administered.
BioSig said it does not intend to further develop merimepodib, although it plans to investigate if other parties are interested in acquiring or licensing the drug.
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