BioSpecifics Reports Top-line Data From Phase 2 Trial Of CCH For Canine Lipoma

(RTTNews) - BioSpecifics Technologies Corp. (BSTC),announced top-line data from Chien-804, the placebo-controlled, double-blind, randomized Phase 2 trial evaluating the efficacy of collagenase clostridium histolyticum or CCH in canines with benign subcutaneous lipomas. Lipomas are encapsulated deposits of fat often detected as bulges under the skin and affect an estimated 1.7 million dogs in the U.S.

The company said the trial did not meet its primary endpoint of a statistically significant post-treatment difference in the mean percent change in lipoma volume by CT scan; however, in the responder analysis there was a statistically significant reduction in lipoma surface area among dogs treated with CCH (p=0.0084).

"We are disappointed that the study did not meet its primary endpoint but are pleased that we achieved statistical significance in a responder analysis of those dogs who had a 50% decrease in lipoma surface area as measured by caliper, which is a standard method for measuring a subcutaneous lipoma.... We are also encouraged to see a high satisfaction rating from the owners of pets who received CCH and hope to be able to offer them this minimally-invasive treatment," said Thomas L. Wegman, President of BioSpecifics.

There were no drug-related serious adverse events reported during the trial. The most frequent treatment-related adverse events were local injection site reactions including bruising, injection site swelling, injection site pain and injection site edema. These adverse events are consistent with those seen previously in clinical experience in humans.

BioSpecifics' strategic partner Auxilium Pharmaceuticals Inc. (AUXL) has the option to exclusively license development and marketing rights to the canine lipoma indication, which would trigger an opt-in payment and potential future milestone and royalty payments from Auxilium.

BioSpecifics expects to submit a final study report to Auxilium in the first quarter of 2014, which will trigger the 120 day opt-in period. If Auxilium does not opt-in, then the rights will revert back to BioSpecifics.

BioSpecifics said it plans to report top-line results from the Phase 2 human lipoma trial in January 2014.