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Posted On: 07/31/2022 2:29:12 PM
Post# of 154867
EUA filed In June for Sabizabulin. A Covid severe and critical single daily pill that the IDMC stopped the phase 3 trial for efficacy of 55+% reduced death. Looks like the new kid on the block with something that actually might get a EUA. Great trial results with a small group of 210 patients. This is also a ARDS possible drug with anti-inflammatory MOA. Has cancer potential also.
We should know our competition and this looks like one we should know about.
What do you think OHM? Is this just a omicron reduced death rate and a lucky trial… Or does this drug hit it out of the park?
From Veru web site
COVID global clinical program
We discovered that sabizabulin, an oral, first-in-class, new chemical entity, cytoskeleton disruptor, which is being developed for cancer indications, has dual anti-inflammatory and antiviral properties. We hypothesized and confirmed in preclinical and clinical studies that based on this mechanism of drug action, sabizabulin may serve as a two-pronged approach to the treatment of COVID-19 viral infection, and the subsequent debilitating inflammatory effects that can lead to ARDS and death. A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial to evaluate the efficacy and safety of sabizabulin 9mg versus placebo was conducted in approximately 210 hospitalized moderate to severe COVID 19 (requiring at least supplemental oxygen) who were at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. After a pre-EUA meeting with FDA, a request for FDA emergency use authorization was submitted June 7, 2022. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. In February 2021, we reported positive Phase 2 clinical study results where sabizabulin treatment demonstrated significant reduction of mortality in hospitalized patients with moderate to severe COVID-19 symptoms who were at high risk for developing ARDS.
We should know our competition and this looks like one we should know about.
What do you think OHM? Is this just a omicron reduced death rate and a lucky trial… Or does this drug hit it out of the park?
From Veru web site
COVID global clinical program
We discovered that sabizabulin, an oral, first-in-class, new chemical entity, cytoskeleton disruptor, which is being developed for cancer indications, has dual anti-inflammatory and antiviral properties. We hypothesized and confirmed in preclinical and clinical studies that based on this mechanism of drug action, sabizabulin may serve as a two-pronged approach to the treatment of COVID-19 viral infection, and the subsequent debilitating inflammatory effects that can lead to ARDS and death. A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial to evaluate the efficacy and safety of sabizabulin 9mg versus placebo was conducted in approximately 210 hospitalized moderate to severe COVID 19 (requiring at least supplemental oxygen) who were at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. After a pre-EUA meeting with FDA, a request for FDA emergency use authorization was submitted June 7, 2022. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. In February 2021, we reported positive Phase 2 clinical study results where sabizabulin treatment demonstrated significant reduction of mortality in hospitalized patients with moderate to severe COVID-19 symptoms who were at high risk for developing ARDS.
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