Positive Phase 2 Results for Halozyme’s Ultra Fast Insulins

Halozyme Therapeutics, a San Diego based biopharmaceutical company, announced positive results from two Phase 2 clinical trials of its ultrafast PH20 insulin analog formulations in patients with type 1 and type 2 diabetes. Both trials met the primary endpoint of non-inferiority of HbA1c compared to the insulin analog comparator, Humalog (insulin lispro), with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms.

Compared to insulin analog alone, PH20 insulin analog use resulted in a greater than 50% increase in the proportion of patients able to consistently achieve AACE (American Association of Clinical Endocrinologists) guidelines for post-prandial glucose targets in both type 1 and type 2 patients. Across all of the treatment groups, there was no meaningful difference in hypoglycemia incidence or event rates. Hypoglycemia events were generally mild, and adverse events with PH20 insulin analog formulations were similar to those observed during the insulin analog comparator phase.

The company is planning a complete presentation of the data at a major medical meeting in 2012. Halozyme intends to explore opportunities that could maximize the global availability of its injectable PH20 insulin analog therapy to patients with type 1 and type 2 diabetes. The company also has an ongoing study in patients with type 1 diabetes who use insulin pumps to determine if a single dose of ultra-fast insulin administered at the beginning of each subcutaneous infusion of analog insulin may reduce the variability of insulin absorption over infusion set life. It is hypothesized that more responsive and predictable insulin absorption over infusion set life may enable patients to further reduce glucose excursions on pump therapy.