Halozyme Therapeutics, Inc.
Additional Data from Phase II Diabetes Study Demonstrates Advantages of rHuPH20
SUMMARY
On 10/1, HALO announced that additional data from a Phase II study of recombinant hyaluronidase enzyme (rHuPH20) co-administered with Humulin-R was presented at EASD. Importantly,
(1) consistent with data presented at ADA from the Humalog portion of the study, co-administration resulted in faster insulin absorption and higher peak insulin concentrations.
(2) We anticipate these advantages could lead to improved glycemic control and lower hypoglycemia and weight gain.
(3) A slightly higher number of injection site reactions (ISRs) were seen for rHuPH20+Humulin, but the study is too small to draw meaningful conclusions.
(4) With progress, we believe HALO's diabetes program will attract a partner, and believe chronic administration data (mid-2010, mid-2011) could catalyze partnership discussions.
KEY POINTS
Data Demonstrates Advantages of rHuPH20 Co-Administered With Humulin-R. Data presented at EASD (PK data from 12 patients, glucose data from 21pts) in Type I diabetics demonstrates rHuPH20+Humulin-R results in faster insulin absorption, increased insulin concentration and reduction in post-prandial glucose levels. This data is consistent with the Humalog portion of study in healthy volunteers.
Advantages of Co-Administration Could Result In Improved Treatment Outcomes. In our view, co-administration with rHuPH20 could lead to improved treatment outcomes for diabetic patients, including reduction in postprandial blood glucose levels and improved glycemic control, decreased incidence of hypoglycemia, and reduced weight gain through insulin dose-reduction.
Additional Humulin AEs But Study Too Small To Draw Conclusion.
Incidences of erythema and ecchymosis (types of ISRs) were higher in the Humulin arm (3) vs. Humalog arm (1). However, the study is too small to draw conclusions (n=22). Also ISRs for rHuPH20+Lispro were in-line with Lispro's alone, which is more important commercially vs. Humulin.
Continued Progress In HALO Diabetes Program Could Help Secure Partnership. We believe advantages of co-administration of insulin with rHuPH20 could attract a partner. Additional safety and chronic administration data (expected mid-2010, mid-2011) could accelerate partnership discussions.
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