Data from interim analyses of a Phase III clinical study in patients with primary immune deficiency (PID) who received Baxter's HyQ were presented at the 26th meeting of the European Society for Immunodeficiencies (ESID) in Istanbul, Turkey. HyQ is an immune globulin (IG) therapy facilitated subcutaneously by recombinant human hyaluronidase, a dispersion and permeation enhancer.
The interim data showed that 28 out of 29 HyQ treated study participants were able to infuse IG under the skin at infusion volumes, intervals and rates equivalent to their previous intravenous administration of IG. The majority of HyQ infusions were administered using a single injection site. The mean maximum infusion rate with HyQ was 245 mL per hour at a single injection site with a mean infusion time of 2.4 hours, which is comparable to intravenous administration. In a tolerability assessment of HyQ, most treatment-related adverse events were mild and localized to the infusion site and included pain and inflammation.
"Currently, patients with primary immune deficiency have to choose between monthly intravenous or weekly subcutaneous immune globulin therapy, which can require multiple injection sites. These data suggest that HyQ, if approved by the FDA, may combine advantageous features of both treatment options by enabling patients with primary immune deficiency to self-administer a full dose of IG treatment with one injection, once a month," said Richard L. Wasserman, M.D., Ph.D., Clinical Professor of Pediatrics at University of Texas Southwestern Medical School, an investigator in the Phase III trial.
In a separate interim analysis based on 23 participants from the same Phase III study, the median dose required to achieve a similar systemic IG exposure to the intravenous administration dose was 107 percent of the intravenous dose for HyQ, compared to 137 percent of the intravenous dose for traditional subcutaneous administration. This translated to a median four-week dose of 507 mg/kg for HyQ, 609 mg/kg for traditional subcutaneous administration and 480 mg/kg for intravenous administration, suggesting that HyQ achieves bioavailability comparable to intravenous administration.
The primary endpoint of the Phase III HyQ study, which has enrolled 89 primary immunodeficiency patients in North America, is prevention of acute serious bacterial infections. The benefit-risk profile of HyQ will be determined upon study completion.
"Baxter has made a commitment to researching and developing innovative therapeutic advances for patients with primary immune deficiency to help them further individualize their care, and HyQ is reflective of that commitment. The interim results for HyQ are encouraging as we work to bring this therapeutic option to patients," said Hartmut Ehrlich, M.D., vice president of global research and development and medical affairs for Baxter BioScience.
Baxter International Inc.