Halozyme Therapeutics reported that the CONSISTENT 1 trial evaluating its diabetes drug Hylenex met its primary endpoint.
The CONSISTENT 1 (CONtinuous Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes) trial assessed the safety and efficacy of Hylenex recombinant and a new formulation of Hylenex undergoing FDA review. The trial will run for 24 months and involve 456 patients with type 1 diabetes. The primary endpoint of non-inferiority of A1C levels at six months was met.
Dr. Bruce Bode, clinical associate professor at the department of medicine in Emory University and study lead investigator, said, “The reduction in hypoglycemia rates observed in this study is encouraging. Reduction of hypoglycemia risk remains one of the key unmet medical needs in the treatment of type 1 diabetes.”
Hylenex recombinant is a tissue permeability modifier indicated as an adjunct therapy to increase dispersion and absorption of separately injected or subcutaneously infused drugs. Hylenex is indicated for the facilitation of subcutaneous fluid administration and in subcutaneous urography. The drug is contraindicated in patients with hypersensitivity to recombinant human hyaluronidase or any excipient in Hylenex.
The drug also reduced the rate of overall hypoglycemic events by 12 percent in combined treatment groups as part of the trial secondary endpoints. Hypoglycemic events with serum glucose were reduced by 23 percent, while the rate of nocturnal hypoglycemia events was cut down by 21 percent in the same patient group compared to the control group.
Dr. Helen Torley, president and CEO of Halozyme, said, “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. 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.”
Headquartered in San Diego, CA, Halozyme is a biopharmaceutical company focused on developing enzymes that target the extracellular matrix. The company primarily focuses on hyaluronidases, a family of enzymes used to increase dispersion and absorption of biologics, drugs, and fluids into the body.