M Pharmaceutical Inc. (CNSX:MQ) shares shot up more than 8% on Monday after the company released findings from the second of three proprietary pilot studies related to the recently acquired Chelatexx technology, referred to as the company's C-103 project which showed 98% success in eliminating gastrointestinal adverse effects.
In this study, which was conducted in the United States, C-103 was over 98-per-cent effective in eliminating the side effects associated with orlistat. This finding is consistent with the first of the three pilot study findings announced on Aug. 11.
The results of the first two studies provide strong validation for the development of the C-103 reformulation of orlistat.
C-103 is a novel formulation of orlistat, patented until 2030 in the United States. Orlistat is Food and Drug Administration-approved for weight management and sold by Roche (VTX:ROG) as Xenical (prescription) and by GlaxoSmithKline (LON:GSK) as alli (over the counter).
Orlistat is the best-selling weight loss medication of all time with peak sales of over $900mln in 2007, but use is limited by socially unacceptable bowel-related side effects (fecal incontinence, oily spotting and flatus with discharge).
C-103 is a patented, proprietary combination of orlistat, simethicone and activated charcoal, which is designed to maintain the efficacy of orlistat while minimizing its bowel-related side effects. The drugs are not systemically absorbed and all are approved by the FDA for OTC usage and have strong safety profiles.
The primary study objective was to demonstrate the effectiveness of a patented, proprietary combination of orlistat, simethicome and activated charcoal to ameliorate the gastrointestinal adverse effects compared with orlistat API (active pharmaceutical ingredient) taken alone. Participants were not asked to change their diets for the study.
"FDA research has documented that over 90% of orlistat users have experienced adverse events termed underwear issues. According to FDA data, approximately 90% of orlistat users discontinue the product within a month due to those underwear issues," said Gary Thompson, president of M Pharmaceutical USA Inc.
"Working with the knowledge that the Chelatexx technology (C-103) has the potential to significantly reduce the adverse events commonly experienced by consumers of orlistat, our objective is to formulate these technologies, orlistat and Chelatexx, into one sequential-release duel compartment capsule that maintains the efficacy of orlistat, but without the messy adverse events."
The shares were last seen up 8.7% at C$0.12.