Replies to post #21771 on Humanigen Inc (fka HGENQ)

[cowtown jay]

Looks like it's not an either/or reason, Knuckle.

In much the same way that CYDY has been required to raise their 75% interim review population to 390, so have we. From our Nov 6th Press Release:

"The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial."

https://www.humanigen.com/press/Humanigen-Announces-Positive-Interim-Phase-3-Data-of-Lenzilumab%E2%84%A2-in-Patients-Hospitalized-with-COVID-19?utm_campaign=2c9a5d27-c185-4e58-a4de-3b497fa85002&utm_source=so&utm_medium=mail&cid=5f2ca5db-61bc-4e3f-a805-dbcc48b3e7a3

To my knowledge, that is the only instruction CYDY has received or reported.

But we have additional instruction, which seems to be targeted to our completed Phase III.

"At the recommendation of the DSMB, the company plans to increase enrollment to achieve 402 events (approximately 515 patients). This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90 percent."

Why the different instructions to the two companies, if it is accurate to say that?

Because, "Based on this feedback from the DSMB, we believe the Phase 3 trial is significantly de-risked. Targeting 402 events improves the probability of success, maintains the power of the study at 90 percent, and further supports our plans for Emergency Use Authorization (EUA) and Biologics License Application (BLA) submission,” said Dale Chappell, MD, MBA, chief scientific officer of Humanigen. “We are working to quickly activate additional trial sites across the U.S. to support rapid enrollment and increase access to lenzilumab with a continued commitment to inclusion and diversity.” So not an either/or situation. The increase is for both an EUA and a BLA.

I think CYDY may be targeting a BLA for leronlimab to treat HIV, so it doesn't necessarily have to be folded into their Covid study.