March 25, 2014
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced top-line data from a proof of concept Phase 1/2 clinical trial evaluating the use of HTI-501 in the treatment of cellulite. The primary endpoint of the clinical trial was met, showing a statistically significant improvement in the appearance of cellulite in the areas of the patients' skin treated with HTI-501 as determined by physician assessment 28 days after treatment compared to the same skin areas prior to treatment and skin areas treated with vehicle control. In follow up, the effect, as assessed by physician assessment, was maintained at three and six months.
"We are very pleased that this study has shown successful proof of concept of the activity of this novel enzyme," said
, M.D., past President of World Congress of Cosmetic Dermatology and principal clinical investigator for the study. "These data support further development of HTI-501 as a potential treatment for cellulite, a highly prevalent condition with very limited therapeutic options."
In the 36 evaluable patients, the skin areas treated with HTI-501 showed a statistically significant reduction in the appearance of cellulite at the primary 28 day observation point, with a mean improvement of 53% (p<.001) compared to the same skin area pretreatment, as assessed by the treating physician. The mean improvement from pretreatment was 33% at 28 days (p<.001) for the skin areas treated with the control vehicle injection, significantly less than the mean improvement for HTI-501 (p=.005).
The Phase 1 dose-escalation portion of the trial was completed in 2012. The Phase 2 portion completed dosing in
and was designed to assess the pharmacologic activity of HTI-501 and extend the safety evaluation to include multiple injections in a treatment area. The primary endpoint was physician assessment at day 28 with continued follow-up of patient responses through six months following treatment. The trial was conducted in
in healthy adult females with cellulite, known medically as edematous fibrosclerotic panniculopathy.
Additional Study Details
In addition to the primary assessments and to better understand the placebo effect, an independent blinded panel evaluation was performed on images from the evaluable patients. Three board certified dermatologists independently reviewed and categorized paired images of treated skin areas as better, slightly better, not different, slightly worse, or worse at 28 days after treatment compared to the same skin areas pretreatment. Panel members were blinded as to which images were pre- and post-treatment and whether the treatment was with HTI-501 or the vehicle control. The panel found that at day 28, the appearance of cellulite was improved from pretreatment for areas of skin treated with HTI-501 (p=.017). In contrast, the appearance of cellulite was not significantly different from pretreatment for areas of skin treated with the vehicle control (p=.20). Furthermore, HTI-501 treatment showed a statistically significant improvement relative to treatment with the vehicle control (p=.007).
Based on the treating physician assessment, the reduction in the appearance of cellulite was also observed at three months and maintained through the final month six follow up observation in this trial. For 35 subjects who remained on study at the three month observation point, the physician assessment showed a mean improvement of 57% (p<.001) from the same skin area pretreatment for the patients treated with HTI-501. In comparison, the mean improvement from pretreatment was 43% at three months (p<.001) for the skin areas treated with the control vehicle injection. For 34 subjects who remained on study through the final six month observation point, the physician assessment showed a mean improvement of 61% (p<.001) from the same skin area pretreatment for patients treated with HTI-501. In comparison, the mean improvement from pretreatment was 43% at six months (p<.001) for the skin areas treated with the control vehicle injection. The independent expert panel also reviewed the three month and six month images from the treatment and control arms compared with the skin areas pretreatment, and noted a significant improvement in the treatment arm at six months, but not at three months, with skin areas treated with HTI-501, and no difference at either three or six months with skin areas treated with vehicle control.