Halozyme Therapeutics Inc (HALO)

[rod5247]

"Some analysts believe it could achieve best-in-class status due to partner Halozyme's promise to improve the efficacy of individual subcutaneous injections and reduce the required dose with its delivery platform."

After checking clinicalTrials.gov, Pfizer was testing 75mg, 150mg and settled on 150mg for study dose every two weeks.

The planned Phase I is dosing 300mg without rhuph20, 150/300/450mg with rhuph20 so reducing the dose does not appear to be the objective. They could be looking for improved efficacy and/or less frequent dosing.

imo, they are looking for once a month dosing and think 300mg is the ticket since that is only cohort with subjects with hypercholesterolemia receiving a statin.

"Experimental: Cohort 4: bococizumab 300 mg + rHuPH20
bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to subjects with hypercholesterolemia receiving a statin"

"LDL-C at Week 4 [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
Absolute value, and absolute change and % change in LDL cholesterol at Week 4 following bococizumab administration alone and when co-mixed with rHuPH20."

ClinicalTrials.gov Identifier:

NCT02667223