Gastrointestinal focused developer ColonaryConcepts said today it cleared a Phase 2 study of its investigational colonoscopy prep kit, reporting that over 90% of patients using the company’s system had ‘excellent’ or ‘good’ rated colonoscopies.
Individuals in the 65-patient trial trial reported high rates of satisfaction with the kit and experienced no serious adverse events, according to the Boston-based company.
“We are very pleased with the results of this study, which provide strong clinical evidence supporting our approach and negate the long-held belief that fasting and the ingestion of high volumes of fluids are required for proper colonoscopy preparation. The results from this study – more than 90% of patients using the lead formulation had ‘excellent’ or ‘good’ rated colonoscopies – clearly encourage us to expand our investigations to a Phase 3 clinical trial, which we plan to initiate in Q4 2016,” co-founder Dr. Corey Siegel said in a press release.
The company said it has plans to meet with the FDA in August this year to discuss plans to proceed to Phase 3 clinical trials with the colonoscopy prep kit.
“Patients participating in this clinical study reported high satisfaction. That’s good news because we are determined to help make it easier for all patients to undergo regular colorectal screening – still recognized as the best way to catch this cancer at an early stage,” co-founder Dr. Joshua Korzenik said in a prepared statement.
The company’s colonoscopy prep tech includes formulated kits designed to address patients’ major pain points in preparing for the procedure, and the company is seeking FDA approval under the statutory 505(b)(2) NDA regulatory pathway.
“ColonaryConcepts was specifically founded to respond to a clear patient-voiced need for a better patient experience in colonoscopy. Our goal is to increase compliance with this life-saving cancer screening procedure. While the novel colonoscopy prep kit is our most advanced product, we are also creating a pipeline of other products for gastrointestinal health that use food as a delivery vehicle for active pharmaceutical ingredients and that address the needs of specific patient populations within both the prescription and over-the-counter drug markets,” CEO Herbert Stern said in prepared remarks.
