Humanigen Inc (HGENQ)

[cowtown jay]

Last March, DTGoody provided the following link.

https://www.humanigen.com/covid-19

This was the announcement of our topline results. However, there were also links to several articles that Humanigen had archived. In reviewing the articles, I questioned why Humanigen would provide information regarding tocilizumab.

https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1

I thought that Corundum gave me a very plausible response.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162557306

In any event, the archived articles clearly show Humanigen's awareness of competitive products.

One month after the tocilizumab preprint is published, in March of 2021, "Roche Group member Genentech has reported that the Phase III REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) failed to meet its primary, as well as secondary endpoints."

https://www.clinicaltrialsarena.com/news/genentech-tretament-fails-endpoints/

Nevertheless, last month, the FDA grants Hoffmann-La Roche, Ltd.
C/O Genentech, Inc., authorization for the emergency use of Actemra.

https://www.fda.gov/media/150319/download

Note the language in the EUA for tocilizumab (Actemra).

"The data supporting this EUA for Actemra are based on four clinical trials. These included one randomized, controlled, open-label, platform trial [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA). While all four clinical trials contribute to the FDA’s understanding of Actemra for the treatment of COVID-19, the most important scientific evidence on the potential benefit of Actemra for its authorized use came from the RECOVERY and EMPACTA trials."

Okay...so, just what were the results for the FDA grant an EUA to Roche/Geneneron on June 24th (and not yet to us, even though they have had our application for an EUA since May 28th, and are aware that we successfully met our primary and secondary endpoints)?

Here's a synopsis and links of the four tocilizumab trials.

1. REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) failed to meet its primary, as well as secondary endpoints.

https://www.clinicaltrialsarena.com/news/genentech-tretament-fails-endpoints/

2. EMPACTA Clinical and Safety Findings

Primary endpoint was met: patients with COVID-19 associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.

There was no significant difference vs palcebo on secondary endpoints

https://www.roche.com/investors/updates/inv-update-2020-09-18.htm

The FDA is fully aware that we demonstrated between a 54% - a 90% effective rate of reducing the need for ventilation.

3. COVACTA trial

Roche’s Actemra fails to meet Phase III goals in Covid-19 patients
29 Jul 2020 (Last Updated August 7th, 2020 12:16)
Roche has reported that its Actemra/RoActemra (tocilizumab) drug failed to meet the primary endpoint of improved clinical status in the Phase III COVACTA trial involving hospitalised adults with severe Covid-19-related pneumonia.

The key secondary endpoints, including the difference mortality at week 4, were also not met.

https://www.clinicaltrialsarena.com/news/roche-actemra-covid-data/

4. RECOVERY trial results

In the safety population, serious adverse events occurred in 103 of 295 patients (34.9%) in the tocilizumab group and in 55 of 143 patients (38.5%) in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group (weighted difference, 0.3 percentage points; 95% CI, –7.6 to 8.2; nominal P=0.94).

CONCLUSIONS
In this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days. (Funded by F. Hoffmann–La Roche and the Department of Health and Human Services; COVACTA ClinicalTrials.gov number, NCT04320615. opens in new tab.)

https://www.nejm.org/doi/full/10.1056/NEJMoa2028700

If we're not getting screwed by the NIH, we're getting screwed by the FDA.

But, we're not the only ones getting screwed here. The governments and other entities that are waiting on our EUA are also getting screwed, as are the patients all over the world who need this drug.

Most of the current Covid cases are outside of the US. Foreign regulators have options, outside of a US regulatory approval, to provide this life-saving therapeutic to their citizens. I hope they do whatever is necessary to get lenz for their patients.