Halozyme (HALO) Says Prandial Insulin + rHuPH20 Phase 2 Met Primary Endpoint in Type 1 Diabetes Patients
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Halozyme Therapeutics, Inc. (Nasdaq: HALO) reports results from a Phase 2 study of prandial insulin formulations, which include the Company's recombinant human hyaluronidase (rHuPH20) enzyme, in patients with Type 1 diabetes. The study met its primary endpoint of A1C non-inferiority (A1C is a measure of average blood sugar over three months). Further, data from the study indicated that rHuPH20 reduced postprandial glycemic excursions, as well as significantly reduced hypoglycemic events. These findings were presented in an oral presentation at the 72nd Scientific Sessions of the American Diabetes Association (ADA) on Monday, June 11 from 6:15 - 6:30 PM EDT.
Details:
The study compared two rapid acting insulin analog products (lispro or aspart), formulated with rHuPH20 (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone). The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.05, +.15). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.9%. Data from the study also showed that mean post-meal glycemic excursions (measured at 90 minutes) in the patient groups treated with Analog-PH20 were reduced by 82 percent (p=.0045), with more patients consistently achieving post-prandial glucose targets for at least two-thirds of their meals, as compared with the patient group treated with lispro alone. For those patient groups treated with Analog-PH20, overall hypoglycemic rates as defined by the ADA (glucose <70 mg/dL) were reduced by 5 percent (p=.035) and hypoglycemic events as defined by a more stringent definition (glucose <56 mg/dL) by 7 percent (p=.044), as compared with the patient group treated with lispro alone.
Additionally, over the 12 week study period total daily insulin dose with the Analog-PH20 treatment groups was comparable (54+27 U vs. 56+27 U, p=.057) as was weight change (-0.25 lbs. vs. +0.10 lbs., p=.27), compared with the patient group treated with lispro alone. Adverse events were also comparable between treatments, with no meaningful difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated. Treatment phase severe adverse events were limited to hypoglycemia, which occurred in two subjects treated with lispro alone.
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Details:
The study compared two rapid acting insulin analog products (lispro or aspart), formulated with rHuPH20 (lispro-PH20 and aspart-PH20, each an Analog-PH20), to an active comparator (lispro alone). The study met the primary endpoint, showing that the Analog-PH20 formulations were non-inferior for A1C, compared to lispro alone (0.4% margin) with no treatment difference (95% CI -.05, +.15). Patient groups in all treatment arms of this study achieved excellent blood glucose control, with endpoint A1C values <6.9%. Data from the study also showed that mean post-meal glycemic excursions (measured at 90 minutes) in the patient groups treated with Analog-PH20 were reduced by 82 percent (p=.0045), with more patients consistently achieving post-prandial glucose targets for at least two-thirds of their meals, as compared with the patient group treated with lispro alone. For those patient groups treated with Analog-PH20, overall hypoglycemic rates as defined by the ADA (glucose <70 mg/dL) were reduced by 5 percent (p=.035) and hypoglycemic events as defined by a more stringent definition (glucose <56 mg/dL) by 7 percent (p=.044), as compared with the patient group treated with lispro alone.
Additionally, over the 12 week study period total daily insulin dose with the Analog-PH20 treatment groups was comparable (54+27 U vs. 56+27 U, p=.057) as was weight change (-0.25 lbs. vs. +0.10 lbs., p=.27), compared with the patient group treated with lispro alone. Adverse events were also comparable between treatments, with no meaningful difference in adverse events, immunogenicity or injection site pain and Analog-PH20 was well tolerated. Treatment phase severe adverse events were limited to hypoglycemia, which occurred in two subjects treated with lispro alone.
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