BioSig Technologies Inc. (NASDAQ: BSGM) was absolutely crushed on Monday after the company announced that it would halt its midstage coronavirus study. Unfortunately, management doesn’t see the trial meeting its primary safety endpoints, so they are pulling the plug.
Specifically, these results come from the Phase 2 study evaluating the safety and efficacy of merimepodib in combination with intravenous remdesivir in adult patients with advanced COVID-19.
At the time of the most recent review of the data by the Safety Monitoring Committee (SMC), 44 patients had been enrolled in the trial, of whom 42 had received study drug (either merimepodib solution or matching placebo).
This most recent review of the data documented all 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37-day follow-up period. However, there were markedly different outcomes for patients who were NIAID Grade 3 (patients who require high flow, high concentration oxygen to maintain adequate oxygenation).
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. As a result, the company intends to stop enrollment for the trial and it would be halted altogether.
Management noted that it does not intend to further develop merimepodib. However, BioSig will see if other parties are interested in acquiring or licensing merimepodib.
Excluding Monday’s move, BioSig Technologies stock had underperformed the broad markets with a decline of about 15% year to date. In the past 52 weeks, the share price was down closer to 33%.
BioSig Technologies stock traded down about 38% to $3.12 on Monday, in a 52-week range of $2.36 to $12.43. The consensus price target is $17.00.