Halozyme's HTI-501 Meets Primary Endpoint In Phase 1/2 Clinical Trial

(RTTNews) - Halozyme Therapeutics, Inc. (HALO), a company whose research focuses primarily on family of human enzymes known as hyaluronidases, which increase the dispersion and absorption of biologics, Tuesday said the primary endpoint of the Phase 1/2 clinical trial of HTI-501, a proprietary recombinant human protease, was met. The trial showed a statistically significant improvement in the appearance of cellulite in the areas of the patients's skin treated with HTI-501.

"We are very pleased that this study has shown successful proof of concept of the activity of this novel enzyme," said Francisco Perez, past President of World Congress of Cosmetic Dermatology and principal clinical investigator for the study.

In the 36 patients evaluated, the skin areas treated with HTI-501 showed a statistically significant reduction in cellulite at the primary 28 day observation point, with a mean improvement of 53% (p<.001) compared with the same skin area pre-treatment, as assessed by the treating physician. The mean improvement from pre-treatment was 33 percent at 28 days (p<.001) for treatment with control vehicle injection, which compares to the mean improvement for HTI-501 (p=.005). The primary endpoint was physician assessment at day 28 with continued follow-up of patient responses through six months following treatment.