Humanigen Inc (HGENQ)

[Corundum]

Some issues with Kiniksa's Mavrilimumab study, which you should read at clinicaltrials.gov.

1. There are/were 588 patients split into 6 groups of study, so about 100 per group unless they weighted more to one part of the study. This is way under-powered for statistical significance, and way below what FDA is demanding these days. This means an all new study has been required.

2. The groups getting the Mavri drug were getting (in one dose) from 1/3 to 1/2 the amount of drug that HGEN is providing in total (3 doses over 24 hours). Since safety was based on these dosage levels, they will have to stick with them, or do an all new safety study first.

3. Half (?) the patients in their study were already on ventilators (but less than or equal to 48 hours). HGEN is not competing in this arena (too difficult to show good results -- the patients are already too inflamed, too sick, etc.) HGEN is a prophylactic treatment that you are supposed to take before you get really sick, even though it is for hospitalized patients with less than 94% oxygen levels. The cytokine storm has not yet arrived for HGEN patients.

4. The Mavri drug goes after a different part (the receptor) of the GM-CSF protein, unlike HGEN and others in the GM-CSF field.

5. The following study seems to question whether the Kiniksa drug (KPL301, formerly CAM3001 as mentioned in the study) can be effective without ongoing infusions of the drug:

https://jlb.onlinelibrary.wiley.com/doi/full/10.1002/JLB.3MA0918-347R

It raises several other serious questions about whether a receptor-based drug will be successful.

I am not a scientist, so my reading of that article/study may be wrong.