BLUE BELL, PA July 15, 2004 -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP)
today announced the results of the Company’s multicenter, Phase 2 study of its next generation sodium phosphate tablet, INKP-102. This new generation purgative is being developed for use in cleansing of the bowel as a preparation for colonoscopy in adults. INKP-102 is free of microcrystalline cellulose (MCC), smaller in size and easier to swallow than the currently marketed Visicol® tablets. The Company has filed a patent application that, if granted, would protect INKP-102 until 2024.
The recently completed, randomized, investigator blinded Phase 2 study included 214 adults who underwent colonoscopy after taking one of seven assigned dosing regimens. The study included six dosing regimens of INKP-102 and the current labeled dosing regimen for Visicol® tablets. The study was designed with input from the FDA, who agreed that this study (assuming appropriate results) and a single Phase 3 study showing non-inferiority compared to Visicol® tablets could be adequate to support approval of INKP-102. Of the six INKP-102 arms, four were administered at a reduced dose compared to the Company’s currently marketed Visicol® tablets and two of these reduced dose regimens were completed using a single-day administration.
The physician performing the colonoscopy, who was blinded with regard to the patient’s treatment group, rated colon cleansing twice, using two different scales: one based on retained “colonic contents” and one based on retained “stool.” Each scale had cleansing ratings of “Excellent,” “Good,” “Fair,” or “Inadequate.” For each scale, a treatment success was defined as an overall colon cleansing rating of “Excellent” or “Good.” The study was not powered to show superiority or pre-defined non-inferiority of the new formulation compared to Visicol®. Rather, the study was intended to be “supportive” of a single Phase 3 study, as recommended by the FDA.
The two cleansing scales produced very similar cleansing ratings. Using the “colonic contents” scale the success rate with Visicol® tablets was 86.2%, very similar to the results in the Phase 3 studies performed to support the approved New Drug Application (NDA) for Visicol®. Five of the six new formulation treatment arms had success rates higher than that of Visicol® tablets. There were no serious adverse events in this study and only one patient dropped out of the study for an adverse event.
“We believe that this study strongly supports the efficacy and safety of INKP-102,” said Martin Rose, M.D., J.D., InKine’s Executive Vice President for Research and Development. “Five of the six new formulation treatment arms had treatment success rates greater than that of marketed Visicol® tablets, including several arms with a reduced tablet dose and one arm where dosing was completed the evening before colonoscopy. These types of modifications to the currently approved dosing regimen represent advantages for patients undergoing colonoscopy, and we intend to study them further in our Phase 3 study of INKP-102,” added Dr. Rose.
Michael P. DeMicco, MD, a study investigator from the Associated Gastroenterology Medical Group in Anaheim, CA stated, “The new MCC-free sodium phosphate tablets demonstrated excellent overall colon cleansing. Patients may prefer the MCC-free sodium phosphate tablets since there are less tablets and fluid to take in less time.”
InKine plans to meet with FDA to reach agreement on the design details of a single Phase 3 study to support the approval of INKP-102. In the Phase 3 study, the Company plans to compare 40 Visicol® tablets to 40 tablets of INKP-102 and at least one additional INKP-102 arm with a reduced number of tablets. Study launch is planned for the second half of this year.
About InKine Pharmaceutical
InKine Pharmaceutical Company,
is a publicly traded specialty pharmaceutical company focused on developing and commercializing pharmaceutical products for the diagnosis and treatment of gastrointestinal disorders. The Company's development strategy is to acquire late-stage drug candidates with short time lines to commercialization. The Company's franchise product, Visicol® is the only tablet purgative preparation indicated for bowel cleansing prior to colonoscopy. InKine's second product, IB-Stat®, is an oral hyoscyamine spray for the treatment of a variety of indications. The Company is also promoting VSL#3®, a probiotic that is effective in treating certain gastrointestinal disorders. Additionally, the Company is developing INKP-102, an advanced generation purgative, which is in Phase II clinical trials for bowel cleansing prior to colonoscopy and Colirest™, which is in clinical trials for the treatment of Crohn's disease. For further information, please visit InKine on its web site http://www.inkine.com.
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