Tuesday, October 11, 2016 7:34:19 PM
Note: in a Phase1 report some pharmacokinetics were reported: GR-MD-02 plasma Concentration vs. Time (hours) profile, eg. at 8mg/kg dosing. Half-lives of 1st and 4th doses are approx equal (18 hrs); after 4 doses the area under the curve (AUC) was approx doubled, indicating the model is
"saturable".
They stated that 8mg/kg dosing is "within the upper range of the targeted therapeutic window", although the derivation of said target wasn't clear, other than based on mouse observations plus a mouse-human equivalency ratio.
Anyway these data, simply on their face, suggest (to me) that an upping of dose frequency would have more potential than dose size escalation.
Final note: I recall GALT reported
(2014) observable efficacy (GR-MD-02) via oral administration (mouse NASH). This was a heckova surprise to me. (But that's a fun feature of science). Carbohydrates are liable to be digested in the GI tract. Molecular lifetime and any breakdown fragments should be identified. Just dreaming...how about a strategic combination of intravenous and oral? Oral could provide convenient boosts between
i.v.'s.
Speaking of boosts, GALT's clinical and i-property would likely be one
for the humdrum pipelines of a lot of Pharmas.
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