Replies to post #36217 on Humanigen Inc (HGENQ)

[DonDonDonDon]

its been 120 and counting days since study concluded.
one thing is certain . it aint no emergency

It has been 120 days since they announced that target enrollment had been reached. We don't know if more patients were dosed after that announcement. And then you have to add 60 days onto the date of the last patient being dosed before the trial concluded. And then they had to wait for each individual treatment site to acquire the data and send it in before they can lock data. The trial can only move as fast as the slowest site and there were more than 50 sites. Things are moving slower than the LIVE-AIR trial but the LIVE-AIR trial locked data after the 29 day endpoints whereas the ACTIV is locking data after the 60 day endpoints. And the ACTIV trial is a government trial. A certain amount of sluggishness is to be expected. Patience grasshopper.

[cowtown jay]

"...it aint no emergency."

"...A double-blind study that ended last week showed that sabizabulin, a new oral medication from pharmaceutical company Veru has the potential to cut the virus’s mortality rate in half for moderate and severe cases. It was so successful, in fact, that researchers stopped the trial early.

“What that implies is that it’s unethical to continue treating people with placebo,” Mitchell Steiner, chairman, president, and CEO of Veru, told Fortune.

While the study was originally meant to involve around 210 patients hospitalized with COVID, an early analysis of the first 150 patients showed such overwhelming success that the study’s independent data monitoring committee recommended halting it. The group of people who took the placebo pill had a 45% mortality rate, while the sabizabulin-treated group had a mortality rate of just 20%...

That's scary to think, that by the time you get into the hospital and you're on oxygen, you have a fifty-fifty chance of surviving,” says Steiner. “This takes some of the scariness out of going to the hospital...

Because of the persistent need for effective treatment for severe COVID, the third phase of Sabizabulin’s trial received “fast track” designation by the Food and Drug Administration (FDA) in January.

Veru is currently seeking emergency-use authorization of sabizabulin from the FDA, which a previous COVID treatment, remdesivir, received in May 2020. That means the drug could be available in just a few months...

Veru is currently in discussions with the Biomedical Advanced Research and Development Authority (BARDA) and other government agencies to secure an advance purchasing agreement for the drug, pending approval from the FDA."

https://fortune.com/2022/04/12/experimental-covid-drug-sabizabulin/

"MIAMI, May 02, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, today announced that the FDA has granted the Company a pre-Emergency Use Authorization (EUA) meeting on May 10, 2022, for the positive Phase 3 COVID-19 study for sabizabulin.

A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4) 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 to complete 60 days of follow-up, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55% relative reduction in deaths. The Company is seeking FDA emergency use authorization. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022."

https://finance.yahoo.com/news/fda-granted-veru-pre-emergency-123000144.html

Some of these numbers are incomprehensible to me. A 45% mortality rate in hospitalized Covid patients?

"...by the time you get into the hospital and you're on oxygen, you have a fifty-fifty chance of surviving,” says Steiner.

"Based on a planned interim analysis of the first 150 patients to complete 60 days of follow-up, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, cytoskeleton disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55% relative reduction in deaths."

A statistically significant mortality rate based on 150 patients? And our LIVE-AIR trial of over 500 patients was too small?

No trial recruitment started yet?

https://clinicaltrials.gov/ct2/show/NCT04842747?term=sabizabulin&draw=2&rank=4