gIcare Pharma Initiates Phase 2a Study of Its Lead Product, GIC-1001, in Sedation-Free Analgesia for Colorectal Cancer Screening
MONTRÉAL--(BUSINESS WIRE)--gIcare Pharma Inc today announced the initiation of a phase 2a study of GIC-1001, a novel orally-administered opioid agonist drug candidate to provide sedation-free, colonic analgesia in patients undergoing colonoscopy.
“The IND has been cleared, and both the FDA and Health Canada agreed with gIcare’s drug development plan. gIcare pharma obtained the support of regulatory agencies in the use of an innovative pain assessment methodology as primary endpoint”
The double-blind, randomized, placebo-controlled, dose-ranging trial will enroll 240 patients in the US and Canada, to assess the efficacy and safety of GIC-1001 for sedation-less colorectal cancer (CRC) screening using video-colonoscopy.
“GIC-1001 was shown to be safe during Phase I trials and we are pleased to announce that the first patient has been enrolled and completed treatment,” said Maxime Ranger, Ph.D., President and Chief Executive Officer, gIcare Pharma Inc.
“The IND has been cleared, and both the FDA and Health Canada agreed with gIcare’s drug development plan. gIcare pharma obtained the support of regulatory agencies in the use of an innovative pain assessment methodology as primary endpoint,” said Sander van Deventer, MD, gastroenterologist and General Partner at Forbion Capital.
“Over the last decade, there has been a significant increase in the use of therapeutics that induce moderate and deep sedation during colonoscopy procedures. Annual sedation-related costs in colonoscopy exceed 5 billion dollars in the US and have yet to show a true procedural outcome benefit,” said Jamie Stiff, Partner at Genesys Capital.
“Contrary to the current standard, GIC-1001 has the potential to provide significant procedural benefit while removing significant costs associated with moderate and deep sedation. It is clear that GIC-1001 aligns with the current US shift from fee-for-service to value-driven healthcare in the era of cost containment,” said Dr. Ranger.
Phase 2a Study Design
The Phase 2a, double-blind, placebo-controlled, dose-ranging study is designed to assess the safety and efficacy of GIC-1001 in 240 adult patients undergoing sedation-free, full colonoscopy. In the study, patients will be randomly assigned to one of three different dose levels (250, 375 or 500 mg) of GIC-1001, or matching placebo, for a 3-day dose regimen (three times a day) and a 10th dose will be taken about 2 hours prior to the colonoscopy. The pharmacokinetics of GIC-1001 will be assessed on a subset of patients (N: 24). gIcare Pharma expects to provide topline results from the study in the second quarter of 2014.
Video-colonoscopy remains the best tool to screen for colorectal cancer and more than 14 million endoscopic procedures are performed annually in the US alone. This number includes 9 million full colonoscopies, which may cause serious discomfort and in many cases, pain. In almost 50% of cases, deep sedation (i.e. propofol) is used, while the other colonoscopies are managed through the use of moderate sedation (e.g. midazolam/fentanyl).
GIC-1001 is an orally-administered, non-centrally-acting opioid agonist interacting with colonic mu- and kappa-opioid receptors. In addition to colon-restricted analgesia, the drug has significant antispasmodic effects, which are expected to reduce colonic spasms, facilitate the insertion and passage of the colonoscope, and then shorten the time to reach the caecum, without interfering with the patient’s normal gastrointestinal tract motility.
About gIcare Pharma Inc
gIcare Pharma is a specialty company, which develops innovative drugs in gastroenterology. In 2011, the Company acquired a patent portfolio, which included GIC-1001, and envisioned the use of non-centrally-acting opioid agonists in colonoscopy. For more information, please visit www.gicarepharma.com
About Forbion Capital Partners
Forbion Capital Partners is a dedicated Life Sciences venture capital firm with offices in Naarden, The Netherlands, and Munich, Germany. Forbion invests in life sciences companies, particularly in world-class drug discovery & development as well as med tech companies addressing substantial unmet medical needs. For more information, please visit www.forbion.com.
About Genesys Capital
Genesys Capital is focused on building companies in the fast-growing sectors of healthcare and biotechnology. Through its expertise and industry network, Genesys accelerates the development of commercially viable emerging companies that represent promising biotechnology investment opportunities. Genesys is one of the largest Canadian-based venture capital firms exclusively focused on the life sciences industry. For more information, visit www.genesyscapital.com