I think most are missing the boat when considering this drug.
Yep, CW said drug.
"M254 is a hyper-sialylated immunoglobulin designed as a high potency alternative
for intravenous immunoglobulin (IVIg), a therapeutic drug product that is
manufactured using pooled, human immunoglobulin G, or IgG, antibodies purified
from blood plasma. IVIg is used to treat several inflammatory diseases,
including idiopathic thrombocytopenic purpura, and chronic inflammatory
demyelinating polyneuropathy. M254 has the potential to remediate the
limitations of IVIg because sialylation of the Fc region of IgG has been seen to
augment the anti-inflammatory attributes of IVIg. We initiated an IND-enabling
toxicology study in 2017 and are targeting the initiation of an initial clinical
study in the second half of 2018. We continue to identify and explore potential
collaboration opportunities to further develop and commercialize this product
candidate.”
OK, so we have a known already approved drug that they have done sialylation of the Fc region. That made the drug up to 10 times more potent. So as I am reading it we need to find the proper dosing amounts and verify efficacy.They have already cross checked it against patient blood samples and done the toxicology study in 2017.
As CW said "it is their sleeper drug.”
Sometime after the next six days they start the phase trial. CW has already indicated he expects it to go relatively quickly.
The thing that has changed is we are not going to give away half of our profits on this potential $6 billion drug.
We are not having to re invent the wheel to get an initial drug approval here. We are seeking to show up to a 10 times improvement in a known drug.
Dosage amounts and safety as I understand. It sounds like they have given a lot of thought to this phase trial.
Boing X 2
