Halozyme Announces that Consistent 1 Trial Of Hylenex® Recombinant Met Primary Endpoint
SAN DIEGO, March 31, 2014 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. The trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under U.S Food and Drug Administration (FDA) review, when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion (CSII) in comparison to no pre-treatment. In accordance with the trial protocol pre-specified analysis of the endpoints, data from the two patient groups treated with Hylenex formulations (treatment groups) were pooled in comparison to a group consisting of patients using standard CSII with rapid acting analog insulin alone (control group). Adverse events were similar across the treatment and control groups. The most common treatment related adverse event in the Hylenex groups was mild infusion site discomfort.
With respect to secondary endpoints, the rate of overall hypoglycemic events (serum glucose of ≤70mg/dL) in the combined treatment groups was reduced by 12% (p=.08) compared to the control group. In addition, the rate of hypoglycemic events where serum glucose was<56mg/dL was reduced by 23% (p=.02) in the combined treatment groups compared to the control group. The rate of nocturnal hypoglycemia events (≤70mg/dL) was reduced by 21% (p=.02) in the combined treatment groups in comparison to the control group. The rate of severe hypoglycemic events (i.e. those requiring the assistance of a third party) was reduced by 61% (p=.08) in the combined treatment groups, in comparison to the control group. Glycemic excursions after meals, and glucose variability as assessed by blood glucose standard deviation, were not different between treatment groups versus the control group.
"The reduction in hypoglycemia rates observed in this study is encouraging," stated Dr. Bruce Bode, Clinical Associate Professor, Department of Medicine, Emory University and the lead investigator for the trial. "Reduction of hypoglycemia risk remains one of the key unmet medical needs in the treatment of type 1 diabetes."
"The data from CONSISTENT 1 will be part of the data package that we will use to seek an update to the Hylenex label with the FDA to include key efficacy and safety data prior to our commencement of promotion for this use," stated Dr. Helen Torley, President and Chief Executive Officer. "We have initiated a dialogue with the FDA to understand the overall data package that will be required and the path to a label update."
Additional Study Details
The CONSISTENT 1 (CONtinuous Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes) trial is evaluating the safety and efficacy of Hylenex® recombinant and a new formulation of Hylenex under FDA review in a 24 month trial in 456 patients with type 1 diabetes. Patients were randomized 3:1 to either a treatment group or a control group. Patients in the treatment groups are administered a Hylenex formulation consisting of 150 units of rHuPH20 once every three days through each new infusion cannula, immediately prior to initiation of insulin delivery. Patients have been provided with individualized instructions to optimize glucose control, including optimization of insulin dosing (both amount and timing) based on an intensive blood glucose monitoring program. The primary efficacy endpoint is comparison of change from baseline in A1C levels at six months using an industry standard non-inferiority margin of 0.4%. Secondary endpoints are hypoglycemia rates, hyperglycemia comparisons, glucose variability and safety endpoints including adverse events, local tolerability and immunogenicity.
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company's research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com and follow us on Twitter @HALOTherapeutic.
About Hylenex® recombinant (hyaluronidase human injection)
Hylenex recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography. Hylenex recombinant is contraindicated in patients with a known hypersensitivity to recombinant human hyaluronidase or any excipient used to make the drug.
The most frequently reported adverse reactions with Hylenex recombinant have been local injection site reactions, such as erythema and pain. For additional information or full Prescribing Information visit www.hylenex.com or www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible benefits, attributes and outcomes regarding the use of Hylenex® in the CSII setting and our intention to seek an update to the Hylenex label to include key efficacy and safety data on use in CSII) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2014.
SOURCE Halozyme Therapeutics, Inc.