Innocoll, Inc., a biotechnology company and portfolio business of Gurnet Point Capital, announces positive topline results from Study INN-CB-024, a Phase 3 randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of a 300mg dose of Xaracoll, a collagen drug-device implant, in patients undergoing abdominoplasty. Among patients receiving Xaracoll, a reduction in pain intensity and opioid use was observed through 24 hours post-surgery.
Study INN-CB-024 enrolled 366 patients, who were randomly assigned to have either Xaracoll 300mg (n=181) or placebo collagen matrix (n=185) implanted during surgery. The primary outcome measure was the time-weighted sum of pain intensity from time of implantation through 24 hours (SPI24). There was a statistically significant treatment effect for Xaracoll compared to placebo in SPI24 (p = 0.002).
Further, approximately three times as many patients in the Xaracoll cohort were opioid-free through 24 hours compared to the placebo-collagen matrix group (18.8% versus 6.5%). This data complements the positive results of Xaracoll in acute post-surgical pain following open inguinal hernia repair in adults, for which Xaracoll is currently approved.
The most common treatment emergent adverse events (TEAE) (>=2% for Xaracoll and greater than placebo collagen-matrix) were dysgeusia (2.2% versus 1.6%), incision site swelling (2.8% versus 2.7%), incision site erythema (2.8% versus 2.2%), postprocedural discharge (2.8% vs 1.1%), back pain (7.7% versus 7.6%), pruritus generalized (2.8% vs. 1.6%), rash (2.2% vs. 1.1%), oropharyngeal pain (4.4% vs 1.6%), blood pressure increased (3.3% vs. 1.6%). There was one serious adverse event of surgical drain-site infection in a patient that received placebo collagen-matrix that was considered unrelated to treatment. No TEAE led to study discontinuation.
These positive topline Phase 3 clinical trial results will support Innocoll’s soft-tissue surgery development program and its anticipated sNDA application to expand the indications for Xaracoll. Additional studies in this development program include surgery types such as abdominoplasty, ventral hernia, hysterectomy, reduction mammoplasty, and colectomy.
“We are excited to report the positive results of this Phase 3 clinical trial with Xaracoll. This study supports Xaracoll’s potential for use in post-surgical pain relief in patients undergoing soft tissue surgery,” says Innocoll President and CEO Louis Pascarella.
Acute postsurgical pain management, especially across soft-tissue surgeries, has historically relied on systemically administered treatments, especially opioid medications. Exposure to opioids post-operatively can result in opioid-related adverse reactions like constipation in the short-term, but in addition several publications have reported that receipt of an opioid after surgery is associated with a risk for persistent opioid use one year later.
Innocoll’s chief medical officer Gwendolyn Niebler, DO, adds, “We are proud of these results. The prospect of providing a non-opioid treatment option like Xaracoll to more patients looking to manage acute post-surgical pain after soft-tissue surgeries is compelling.”
