ATHLONE, Ireland, -- Innocoll AG (INNL), a global, commercial-stage, specialty pharmaceutical company that develops, manufactures and supplies a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the first patient was dosed in the MATRIX-1 (Multisite Assessment of PosToperative Pain Reduction wIth XaraColl) Phase 3 study for the treatment of postoperative pain following open hernioplasty with mesh using XaraColl, Innocoll's surgically implantable and bioresorbable bupivacaine-collagen matrix.
Postoperative pain management is a serious concern for surgeons and patients. According to Life Science Database, there are over 76 million surgeries performed annually in the US with approximately 1.4 million being hernia operations. Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. While opioids are very effective analgesics, opioids also carry with them many undesirable potential side effects: sedation, respiratory depression, nausea and vomiting, hypotension and bradycardia, pruritus, and inhibition of bowel function.
XaraColl acts locally following implantation at the surgical site and is intended to provide sustained pain relief by delivering appropriate concentrations of bupivacaine directly at the site of surgical trauma for up to 72 hours. Bupivacaine is a long acting local anesthetic with a well-characterized safety and efficacy profile. The XaraColl collagen matrix helps deliver that local pain relief for up to 72 hours.
"Postoperative pain management is critical for a successful result of nearly any surgical procedure. When pain is adequately controlled, patients have a better experience." said Dr. James Tursi, Chief Medical Officer at Innocoll. "A better experience for the patient means a better experience for the surgeon. Importantly, the ability to limit or reduce exposure to opioids may enable patients to avoid opioid related side effects and potentially opioid related complications."
The MATRIX-1 Phase 3 study is one of two identical randomized, placebo-controlled, double-blinded studies to investigate the safety and efficacy of a surgically implantable and resorbable bupivacaine-collagen matrix. The second Phase 3 study, MATRIX-2 is expected to start later this quarter. Each study is expected to enroll approximately 300 patients age 18 and older in the United States. Patients with a unilateral inguinal hernia undergoing open hernioplasty with mesh placement will be treated in one of two arms per study: three 100 mg XaraColl matrices for a total dose of 300 mg of bupivacaine hydrochloride or three placebo matrices. The matrices are placed at the site of the hernia repair in order to provide local levels of bupivacaine directly at the location of surgical trauma.
The primary efficacy endpoint is the sum of pain intensity difference (SPID) over 24 hours comparing the XaraColl matrix to placebo. Additional endpoints include the SPID at 48 and 72 hours as well as total opioid use at 24, 48 and 72 hours. Safety will be evaluated through the collection of adverse events through 30 days postoperatively.
To qualify for the study, patients must have a planned (non-emergent) unilateral inguinal hernioplasty (open laparotomy, tension-free technique) to be performed according to standard surgical technique under general anesthesia. Following screening and determination of eligibility, study participants will be assigned to one of two groups. Patients will be treated with implantation of three 100 mg XaraColl matrices (total dose 300 mg) or three placebo matrices. Pain measurements will be recorded at predetermined intervals over the first 72 hours following implantation of the matrices. Enrollment is expected to complete in the first quarter of 2016 and topline results from the study are expected in the second quarter of 2016.
More information on the study will be posted at www.clinicaltrials.gov.
About Innocoll AG
Innocoll is a global, commercial-stage, specialty pharmaceutical company. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies. The company's late stage product pipeline is focused on addressing a number of large unmet medical needs, including: XaraColl(R) for the treatment of post-operative pain; Cogenzia(R) for the adjuvant treatment of diabetic foot infections; and CollaGUARD(R), a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp(R) G, Septocoll(R), RegenePro(R), Collieva(R), CollaCare(R), Collexa(R), and Zorpreva(TM), which are sold through strategic partnerships with various partners including Takeda, Biomet, and EUSA Pharma. All of the company's products and product candidates are made using Type 1 collagen and are manufactured in-house at its facility in Saal, Germany. CollaRx(R), Collatamp(R), CollaGUARD(R), Collieva(R), CollaCare(R), Collexa(R), Cogenzia(R) LidoColl(R), LiquiColl(R), Septocoll(R), and XaraColl(R) are registered trademarks, and CollaPress(TM), DermaSil(TM), Durieva(TM), and Zorpreva(TM) are trademarks of the company.