Halozyme Therapeutics, Inc.’s (HALO) Hylenex recombinant met the primary endpoint in the CONSISTENT 1 study conducted in type I diabetic patients (n=456) by showing non-inferiority of A1C levels from baseline at 6 months. The study is evaluating the safety and efficacy of Hylenex recombinant and a new formulation of Hylenex for pre-treatment of the insulin infusion site in patients dependent on insulin pumps, compared to no pre-treatment.
The study was conducted on two treatment groups and one control group. Patients in the treatment group were administered with Hylenex recombinant while the control group received standard continuous subcutaneous insulin infusion (CSII). The rate of overall hypoglycemic events in the pooled data from the combined treatment groups was found to be reduced by 12% compared to the control group.
Hylenex recombinant, a formulation of rHuPH20, is already approved in the U.S. as an adjuvant for achieving hydration in patients, to facilitate subcutaneous fluid administration, to increase the dispersion and absorption of other injected drugs or to improve the resorption of radiopaque agents.
Halozyme is looking to update Hylenex’s label so that efficacy and safety data from the CONSISTENT 1 study can be included.
Meanwhile, Halozyme is reviewing various strategic alternatives and seeking partnering options for the advancement of its cellulite candidate, HTI-501.
We note that Halozyme has partnered programs with companies like Pfizer (PFE) and Roche (RHHBY) among others.
Halozyme carries a Zacks Rank#3 (Hold). A better-ranked stock in the biotech sector is Alexion Pharmaceuticals, Inc. (ALXN), carrying a Zacks Rank #1 (Strong Buy).
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