ATHLONE, Ireland -- Innocoll AG (Nasdaq:INNL), a global, commercial-stage, specialty pharmaceutical company that develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, today announced that the results of a pharmacokinetic (PK) study to support using a dose of 300 mg of XaraColl, Innocoll's collagen/bupivacaine bioresorbable implant, in its planned Phase 3 studies to evaluate the efficacy of XaraColl in the treatment of post-operative pain.
The 62-patient PK study had 3 main objectives:
- To evaluate the PK profile of 200 mg and 300 mg doses of XaraColl compared to a 150 mg bupivacaine HCl injection in patients undergoing open laparotomy hernioplasty;
- To document maximal systemic levels (Cmax) of bupivacaine; and
- To evaluate the preliminary safety and tolerability of XaraColl treatment.
The study confirmed proportional systemic levels of bupivacaine for both the 200 mg and 300 mg dose XaraColl implants. The maximal mean serum concentrations (Cmax) were below levels that would be expected to result in systemic toxic effects. A preliminary review of safety observations in connection with the PK study suggested both doses were well tolerated.
"We were pleased to find that the PK results are consistent with the expected values across each treatment group and no subjects were reported to have a Cmax that might suggest the risk of systemic toxicity," stated James P. Tursi, M.D., Chief Medical Officer of Innocoll. "Additionally, a preliminary safety evaluation suggests that both the 200 mg and 300 mg doses were well tolerated. This top-line data supports a dose selection of 300 mg to move into our Phase 3 program for XaraColl. We look forward to discussing our plans with the FDA."
Tony Zook, Chief Executive Officer of Innocoll added, "Initiating the XaraColl Phase 3 development program is one of our key objectives for 2015 as we continue to execute on our plans. I'm pleased to also announce that we delivered a positive result for this study within our target timelines. We have previously stated that throughout 2015 we will focus on the execution of our key deliverables. With the previously announced debt financing that we have secured and the generation of this positive data, we are off to a solid start towards achieving those targets."
XaraColl is a biodegradable and fully bioresorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx®. This technology achieves a high concentration of drug at the target tissue, while maintaining relatively low systemic levels. XaraColl is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The product is expected to be available in several different strengths, and is designed such that multiple units can be used per patient, for optimum dosing flexibility and efficacy. XaraColl is easy to use and can be cut or rolled depending on the surgical setting and can be used laparoscopically.
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® for the treatment of post-operative pain; Cogenzia® for the adjuvant treatment of diabetic foot infections; and CollaGUARD®, a barrier for the prevention of post-surgical adhesions. The Company's approved products include: CollaGUARD(Ex-US), Collatamp® G, Septocoll®, RegenePro®, Collieva®, CollaCare®, Collexa®, and Zorpreva™, 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®, Collatamp®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Cogenzia® LidoColl®, LiquiColl®, Septocoll®, and XaraColl® are registered trademarks, and CollaPress™, DermaSil™, Durieva™, and Zorpreva™ are trademarks of the company.